What's New

Pfizer restructures in preperation for potential sell off

Pfizer has announced plans to reorganise into three separate units through the separation of its consumer health care business from the other two arms of the company.

Pfizer is currently comprised of two segments: Innovative Health and Essential Health. The restructuring will involve the formation of a third segment which will take responsibility for all of Pfizer’s over-the-counter brands which were previously dispersed between the other two sections of the business.

The restructuring will also see the Innovative Health branch reorganised under the name ‘Innovative Medicines while the Essential Health’ section of the company will function under its new title Established Medicines. Both branches will see a streamlining of their operation in coming years.

The plan, which will come into effect at the beginning of 2019, is intended to promote “future growth”.  As expanded upon by Pfizer CEO Ian Read:  "As we transition to a period post-2020 where we expect a higher and more sustained revenue-growth profile, we see this new structure better positioning each business to achieve its growth potential."

The restructuring will see biosimilars, which had previously come under the umbrella of Essential Health, included into Pfizer’s Innovative Medicines segment. Equally, a new hospital business unit including anti-infectives and sterile injectables will be incorporated into Pfizer’s Innovative Medicines branch.

Albert Bourla, Chief Operating Officer, noted that; “This design gives us a sharper focus on diverse patients in diverse markets.”

The restructuring has led to commentators discussing the possibility that Pfizer will sell the consumer healthcare branch of its business. As stated by Credit Suisse analyst Vamil Divan: “We believe the potential for Pfizer to ultimately sell or spin the business likely remains on the table over time.”

Otsuka snaps up Visterra in $430 million deal

Otsuka Pharmaceutical has announced it has reached a definitive, board-approved agreement with Visterra to acquire the latter company in an all-cash transaction to the value of $430 million.

The deal will see Otsuka acquire Visterra’s Hierotope platform, a tool which leverages novel computational and experimental technologies in the design of precision antibody-based therapies to target diseases which are not adequately tackled by existing antibody therapeutic technologies. It will also pick up a pipeline which includes candidates for cancer, chronic pain, infectious diseases, and IgA nephropathy and other kidney diseases, complementing its own portfolio in kidney and infectious diseases as well as neurological diseases, haematological cancers, and cardiovascular conditions.

“I am highly gratified that Visterra's exceptional antibody platform technology, promising pipeline and talented researchers will join up with Otsuka,” said Tatsuo Higuchi, the firm’s President and Representative Director. “By collaborating and reinforcing each other's culture, human ingenuity and technology, we hope to help fulfil Visterra’s promise as a powerful new drug creation engine and expand Otsuka’s research horizons.”

Dr Brian J G Pereira, CEO of Visterra, also commented: “This transaction affirms the power of Visterra’s novel technology platform, the promise of our product candidates, and the value our employees and shareholders have created. Our two companies share a common culture of creativity and innovation, and commitment to patients with kidney diseases, cancer and other hard-to-treat diseases. Joining forces with Otsuka will provide Visterra the resources, support and commitment to accelerate development of our pipeline and fully realize the potential of our technology platform,”

The transaction is expected to close in the third quarter of 2018, subject to customary closing conditions.

The MHRA Announces Move
On 18th June 2018, the MHRA moved out of its location in Victoria to a new office in Canary Wharf.

The centres which have moved include:

• the MHRA Regulatory Centre including the British Pharmacopoeia (BP)
• the Clinical Practice Research Datalink (CPRD)

Further information about the move is available via:


The MHRA’s new contact address is:
10 South Colonnade
Canary Wharf
E14 4PU
All contact telephone numbers remain the same.


US government proposes renaming the FDA

The US government has outlined a proposal under which the FDA would be renamed the Federal Drug Administration, with the agency losing its responsibility for regulating food safety. The proposal aims to address “the current fragmented” oversight of food safety; if it goes ahead, the FDA’s remit will be limited to the regulation of drugs, devices, biological products, tobacco, dietary supplements and cosmetics. The plans are part of a wide-ranging initiative that includes renaming the Department of Health and Human Services as the Department of Health and Public Welfare.

Brookwood are pleased to be the principle sponsor for the 16th Pharmacovigilance 2018 conference in Massachusetts, USA 2nd – 4th October 2018

The Global Pharmacovigilance Market expected to Reach US$6.1 bn by 2020 expanding at a CAGR of 14.2% from 2015 to 2020 and also expected to reach a market size of $8.23 billion by 2022. By 2020, the size of the global pharmaceutical market is anticipated to grow to USD 1.3 trillion, with the E7 countries -- Brazil, China, India, Indonesia, Mexico, Russia and Turkey.

16th Pharmacovigilance 2018 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. The entire program will cover the detection, analysis and prevention of adverse drug reactions. It will be studied with the help of case studies and industry experiences.

This conference will help the drug safety representatives from the pharmaceutical industry and academic and quality research organizations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing Pv requirements, and to improve their organizations’ compliance with Pv requirements. Also it can help you control your product’s lifecycle, your patient’s trust, and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting Pv development. What does the future hold for Pv? Find out at our conference on opportunities and activities shaping Pv to 2020 with respect to regulations, technologies and services. Learn and know on what are drug producers and service providers doing? What regulations and technologies influence the current PV field? You can also discover at 16th Pharmacovigilance 2018 on spending forecasts for PV (US, the EU and Asia).

It gives me great pleasure in welcoming all of you to the Virtue Insight’s 16th Pharmacovigilance 2018. I wish and pray that all our efforts will be beneficial to our industries and to our country at large.

Key themes discussed at this conference

• Pharmacovigilance in the US: What comes next for the industry?
• Recent developments - legislation, policies, systems, technology, communication strategies and best practice in PV
• Optimising the overall PV ecosystem - Challenges and Opportunities
• Why does pharmacovigilance sometimes fail and where could the fault lie?
• Pharmacovigilance and healthcare system
• Technology Impact - Cloud – Big data – Analytics – AI – Machine learning
• Updates to PSUR, PBRERs, DSUR, PASS
• Good Clinical Practices and Good Pharmacovigilance practices
• Future of outsourced phase I, II and III trials and post-marketing studies,
• Data quality management and analysis – analyzing the new guidelines
• Strategies to improve clinical trials and PV
• Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
• Patient centric approach to help improve patient safety
• Outsourcing activities - Choosing your right vendor and setting the path right
• PV Audit & inspections - preparation, implementation and lessons to be learnt
• Discover approaches for collecting, integrating and analyzing all of the safety
data generated from preclinical models
• Current regulations and guidelines - USA, EU and RoW
• The developing regulatory framework in advanced and developing markets
• Be part of a major networking opportunity

For more conference details visit www.brookwoodacademy.org/documents/16th-Pharmacovigilance-2018.pdf

Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU

Publication of updated Q+As and practical guidance

The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU).
Updates to the questions-and-answers document are marked ‘NEW’ and include information on how the UK’s withdrawal will affect the status of inspection outcomes by the UK national competent authority and batch release processes for medicines that are subject to Official Control Authority Batch Release (OCABR) and Official Batch Protocol Review (OBPR). The document also clarifies how scientific opinions of the Committee for Medicinal Products for Human Use (CHMP) for ancillary medicinal substances in medical devices requested by UK notified bodies will be affected. In addition, it includes new information on back-up arrangements for Qualified Persons for Pharmacovigilance (QPPVs) and on marketing multi-country packs of medicines, where one of the countries in which the packs will be sold includes the UK.
The Agency has also published an updated version of its practical guidance for industry which outlines the steps that companies should follow to make sure that necessary changes to their marketing authorisation are made by the end of March 2019, to allow for the continued marketing of their medicine in the Union after Brexit. The document should be read in conjunction with the updated questions-and-answers document. All updates are marked ‘NEW’.
Companies are reminded to plan for the UK’s withdrawal from the EU on 29 March 2019 in order to avoid any impact on the continuous supply of medicines for human and veterinary use within the EU and are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU.
More details can be found at http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/06/news_detail_002975.jsp&mid=WC0b01ac058004d5c1

New Industrial Biotechnology Strategy launched to secure UK leadership in clean growth
Today(6th June 2018) the Industrial Biotechnology Leadership Forum (IBLF) launches the new ‘National Industrial Biotechnology Strategy to 2030’, promoted in partnership with the UK BioIndustry Association (BIA). The Strategy has been developed by the IBLF and two collaborative networks in industrial biotech, CBMNet and BIOCATNET.
The ‘National Industrial Biotechnology Strategy to 2030’ aims to ensure that the UK becomes a leader in the global shift towards clean growth by fostering the development of industrial biotech SMEs. It will be launched at an event in Parliament on Wednesday 6 June organised by the BIA and hosted by Daniel Zeichner, MP for Cambridge. The event brings together industry, academia and policymakers to discuss how the UK industrial biotech sector can solve many environmental problems by promoting clean growth and reducing waste, such as oil-based plastics by creating biodegradable alternatives.
The Strategy will be implemented in three phases with actions across seven themes:
1.        External environment – to achieve consensus on a consistent long-term policy landscape that supports industrial biotech
2.        Funding and access to finance – leading to a supportive financial environment that recognises the potential of IB for driving growth and innovation
3.         Infrastructure and regional footprint – ensuring that industrial biotech is a major contributor to clean economic growth across all of the UK
4.        Trade, investment and commercialisation – positioning the UK as an international industrial biotech innovation and commercialisation hub
5.        Regulations and standards – making certain that UK frameworks are recognised as robust and support risk aware innovation
6.        Skills – fostering the skills required by industry to make sure that the industrial biotech sector is recognised as an attractive career option
7.        Communication –  promoting one IB community voice, with consistent clear messages, where wider society is well informed and supportive of Responsible Research and Innovation in industrial biotech
These actions aim to place industrial biotech at the core of the UK Industrial Strategy and the Bioeconomy Strategy, embedding industrial biotech products and processes at the heart of a future high technology economy, driving clean growth and national prosperity.
Steve Bagshaw, CEO of Fujifilm Diosynth Biotechnologies and Chair of the IBLF, said: “The Strategy describes the vision of the UK industrial biotech community, driven by the IBLF; in harnessing the world-class science we have in the UK in order to enable industrial biotech to become a mainstream part of UK industry. Through industrial biotech we can find sustainable alternatives to fossil fuels for the production of everyday chemicals, materials and energy, as well as delivering new functionalities and benefits. Industrial biotech is the only way to manufacture unique biopharmaceuticals. These help tackle serious illness such as cancer and infectious diseases. Industrial biotech can mitigate climate change through the development of greener, cleaner manufacturing processes, as well as offering opportunities for waste utilisation and new products that benefit society that cannot be made any other way.”
Dr Tim Fell, CEO of Synthace and Chair of BIA’s Engineering Biology Advisory Committee, said: “It is fantastic to see the publication of the Strategy, which will act as a catalyst for the growth of UK’s industrial biotech sector. Synthetic biology is a key enabler of industrial biotech and the two share many of the same opportunities and challenges. The BIA’s Engineering Biology Advisory Committee is at the heart of the UK’s thriving sector, bringing together companies working at the interface of synthetic biology and industrial biotech to develop innovative technologies for a healthier and environmentally sustainable society. The Strategy highlights the importance of industry and government working together to achieve this common goal.”
Steve Bates OBE, CEO of BIA, said: “Industrial biotech plays a key role in societal goals like helping eliminate avoidable plastic waste which David Attenborough’s TV programme Blue Planet 2 has brought to recent public attention. The BIA is delighted that today’s strategy showcases UK entrepreneurs unleashing the innovation that will provide not only a cleaner, greener Britain but also prosperity for the next generation. This sector is key to developing the technologically and economically practical innovation needed to deliver the environmental objectives of the UK government.”
Daniel Zeichner, MP for Cambridge, said: “It is crucial that as we plan for the future, we make sure that clean growth is at the heart of our development strategies. Clean growth is central to making an industry or business sustainable, so it is excellent that industrial biotech has focused on this. My constituency, Cambridge, is an international innovation hub for this sector and has fantastic clean tech; local bioindustry recognises the importance of reducing waste. I look forward to seeing how we can become cleaner and greener in the future.”
Paul Mines, CEO of Biome Bioplastics, said: “The current scale of oil-based plastic waste is no longer acceptable to UK consumers. Bioplastics offer a viable and responsible alternative, however, they only account for a fraction of today’s plastic production. Industrial biotechnology provides the underpinning science that will unlock improved material performance and use of bio-based inputs leading to widespread use of the next generation of bio-based and biodegradable plastics. The Strategy announced today provides a framework for industrial biotechnology in the UK that will allow SME’s, like Biome Bioplastics, to play their part in the clean growth agenda by growing fast whilst reducing waste.”

Updated "Sponsor's Guidance" for Clinical trial application in France
For more details visit: http://ansm.sante.fr/var/ansm_site/storage/original/application/90105aa64b104e53265ce9ef6ca25da3.pdf

UK MPs call for Brexit priority over pharma industry

A new report published by the Business, Energy and Industrial Strategy Committee has called for the UK government to ensure that the pharmaceutical industry is aligned as closely as possible to European regulation post-Brexit.

The call is the most direct recommendation yet, from within government, for what the pharmaceutical industry has been asking for since Brexit was first announced.

Theresa May did give some indication, in March, that she would like to see some UK industries remain regulated by EU agencies, by “making an appropriate financial contribution” to retain their services.

The report, The impact of Brexit on the pharmaceutical sector, delineates clearly why not managing to achieve this would be so damaging to the UK industry. It highlights that with £11.9 worth of exports to consumers in the EU, the UK economy cannot risk damaging this relationship.

In addition, it notes that trade between the UK and EU countries is vital, two-way relationship, with 446 million consumers to trade to in the bloc and three quarters of UK medicines coming from the EU.

Perhaps less convincingly, the report argues that a separate regulatory system in the UK could result in an additional cost of £45,000 for every new product released, suggesting that this would damage desire to market in the UK. In reality, this cost per product is small change for most pharmaceutical companies.

Rachel Reeves MP, Chair of the Business, Energy and Industrial Strategy Committee, said: “The Government’s own analysis identifies pharmaceuticals as the sector for which UK/EU market access is the most important given the industry is reliant on friction-free border movement for their products.  Any delays at the border faced by short-life pharmaceuticals for emergency treatments would have a hugely detrimental impact on patients.

“The Prime Minister has previously set out a positive and compelling case for continued cooperation on medicines, but, with the clock ticking, it is now time for the Government to end the uncertainty and translate words into actions. Some form of membership of the EMA is vital to the continued success of the pharma industry and to the welfare of British patients and the Government should strike a deal to keep some of the organisation’s jobs and facilities in the UK, to continue to share our world-leading expertise.”

A statement released by the ABPI, unsurprisingly, supported the findings of the report: “Every month, 45 million packs of medicine move from the UK to the EU, with 37 million moving the other way. Today’s Select Committee Report is right - a Brexit ‘no deal’ would significantly damage public health, patient access to medicines and the UK’s leading pharmaceutical sector. This must be avoided at all costs. Securing cooperation on the regulation, trade and supply of medicines must be a priority for both the UK Government and the EU.”

FDA Proposed Rule: Responsibilities for the Initiation and Conduct of Clinical Investigations

FDA says in April 2019, it will propose rule updates to investigational new drug application (IND) regulations to define and clarify the roles and responsibilities of persons engaged in the initiation, conduct, and oversight of clinical investigations subject to IND requirements. “The proposed changes would better protect the rights, safety, and welfare of subjects and help ensure the integrity of clinical trial data. The proposed rule should help reduce study misconduct and ensure the integrity of clinical trial data (benefits) while requiring additional documenting, reporting, and recordkeeping for clinical investigators (costs),” according to the announcement.
Final Rule: Post-marketing Safety Reporting Requirements for Human Drug and Biological Products:
This final rule would amend regulations for post-marketing safety reporting for human drugs and biological products, including blood and blood products, to better align FDA requirements with ICH guidelines and update reporting requirements in light of current pharmacovigilance practice and safety information sources. It would also enhance the quality of safety reports received by the agency.
The revisions were proposed as a part of a single rulemaking to clarify and revise pre-marketing and post-marketing safety reporting requirements for human drug and biological products. The pre-marketing safety reporting requirements were finalized in a separate final rule published on Sept. 29, 2010. The final rule applies to post-marketing safety reporting requirements.
Final Rule: Fixed Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph:
The final rule, which is expected in February 2019, amends FDA regulations on fixed-combination prescription and OTC drugs. Current regulations require that the sponsor of a fixed-combination drug show that each of the components contributes to the drug’s claimed effects.
“The final rule harmonizes the combination drug requirements into a single set of regulations for both prescription and OTC combination drugs, and codifies existing policy on what kinds of studies are needed to show that the combination drug requirements are met,” the FDA said.
It also applies the regulations to “combinations of biological drug products and to drug-biological product combinations; clarifies application of FDA's requirements regarding fixed-dose combinations to certain natural source drugs and certain synthetic drugs; establishes circumstances under which the Agency might waive the combination requirements for a particular drug or biological product; and addresses the issue of co-packaging,” the agency said.
Proposed Rule: Certain Requirements Regarding Prescription Drug Marketing (203 Amendment)
The FDA also plans to issue a proposed rule by November 2018 to amend prescription drug marketing rules to align with the provisions of the Drug Supply Chain Security Act by November. The rulemaking will clarify existing regulations to reduce confusion with the DSCSA’s standards for wholesale distribution.
Proposed Rule: Biologics License Applications and Master Files
The agency plans to issue a proposed rule this month on drug master files for biologics license applications. Under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), any biological product approved in a new drug application will be considered a BLA from March 23, 2020. The proposed rule would permit the use of DMFs for NDAs subject to the BPCI Act transition.
Proposed Rule: Post Approval Changes to Approved Applications
A proposed rule planned for March 2019 will update current FDA rules on post-approval amendments to approved NDAs, ANDAs and BLAs and update regulations on certain post-approval reports.
Direct Final Rule: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
Scheduled for this month, this final rule will permit an Institutional Review Board (IRB) to waive informed consent under certain conditions for minimal risk clinical investigations. According to the announcement, this will “facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat disease and will harmonize with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies.”
Proposed Rule: Responsibilities for the Initiation and Conduct of Clinical Investigations
FDA says in April 2019, it will propose rule updates to investigational new drug application (IND) regulations to define and clarify the roles and responsibilities of persons engaged in the initiation, conduct, and oversight of clinical investigations subject to IND requirements. “The proposed changes would better protect the rights, safety, and welfare of subjects and help ensure the integrity of clinical trial data. The proposed rule should help reduce study misconduct and ensure the integrity of clinical trial data (benefits) while requiring additional documenting, reporting, and recordkeeping for clinical investigators (costs),” according to the announcement.
Proposed Rule: Institutional Review Boards; Cooperative Research
Expected last year but now slated for December 2019, this proposed rule would replace current FDA requirements for cooperative research such that “any institution located in the U.S. participating in multisite cooperative research would need to rely on approval by a single IRB for that portion of the research that is conducted in the U.S., with some exceptions. This proposed rule also would also establish an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution.”
Proposed Rule: Pediatric Study Plan requirements for New Drug and Biologics License Applications
Already past the 2013 statutory deadline for these rules, and now slated for April 2019, this proposed rule would establish requirements for the content of initial pediatric study plans required to be submitted under the Pediatric Research Equity Act (PREA) which requires sponsors of certain applications to submit a plan for studying their drug/biologic in pediatric patients; a primary factor in the increased ability to provide labeling and other drug information for pediatric patients for many more drug and biological products. “Although the plans are required to be submitted based on the statutory provision, a regulation is required and will provide clarity, specificity, and direction to sponsors, as well as assist FDA in ensuring compliance, and ultimately help to better advance the study of drugs in pediatric populations to support advancing pediatric indications,” states the announcement.
Read the full agenda here: https://bit.ly/2IcyFW4

Anmeal and Impax create diversified pharmaceutical company.

Amneal Pharmaceuticals LLC and Impax Laboratories Inc. have completed their business combination to form Amneal Pharmaceuticals, Inc. ("Amneal" or the "Company"). As a diversified company with a robust generics business, Amneal is now the 5th largest generics business in the US, with a growing, high-margin specialty franchise.
Shares of Impax ceased trading on the NASDAQ stock exchange on 4 May 2018. Amneal will begin trading today on the New York Stock Exchange (NYSE) under the ticker "AMRX". Pursuant to the business combination agreement, each share of Impax common stock was converted into the right to receive one share of Amneal Class A common stock.
"We are very excited for the future of Amneal, and strongly believe that with our team, differentiated product portfolio, extensive R&D and manufacturing infrastructure and expertise, Amneal is well positioned to become an industry leader," said Chirag Patel and Chintu Patel, Co-Founders and Co-Chairmen of Amneal. "We are very proud of the Company we have built and look forward to Amneal's continued success under Rob Stewart's leadership."
Robert Stewart, President and CEO of Amneal, said: "As we enter our next stage of growth, we look forward to implementing our integration plans and quickly starting to realize the many benefits of this combination. We will promptly begin to leverage our enhanced product portfolio to fuel organic growth while capturing numerous synergies to unlock value and generate strong cash flow to support the rapid repayment of debt and further investment in growth opportunities."
The Company expects to benefit from its expanded product portfolio, differentiated pipeline and cost-efficient global manufacturing and development capabilities in nearly all dosage forms. Amneal expects to generate annual double-digit revenue and adjusted EPS growth and to achieve annual cost synergies of approximately $200 million within 3 years.
"This is a truly transformative combination that firmly establishes Amneal as an industry leader, with high-value generic product pipelines and a growing specialty business," said Paul Bisaro, Executive Chairman of Amneal. "With our combined resources, we are well-positioned to execute our plans to bring high-quality, affordable medicines to patients and generate long-term returns for our shareholders."
Review of the Strategic and Financial Benefits of the Combination
•  The Company currently has a generics portfolio with more than 200 differentiated product families marketed in nearly all dosage forms and holds a number one or number two position in a significant number of its marketed products, and has a growing specialty franchise targeting CNS disorders and anti-parasitic infections.
•  The generic products pipeline is currently one of the largest in the US, including approximately 149 ANDAs filed at the FDA and 135 projects in active stages of development, with nearly half of all pipeline products exclusive first-to-file, first-to-market or other high-value opportunities with three or fewer competitors estimated at the time of launch. In addition, the Company has a foundation for commercial entry into biosimilars through in-licensed products in various stages of development.
•  The Company is committed to ongoing investments in R&D with an expected annual investment of approximately 10% of net revenues, with a focus on the strategic development of high-value products within generics and specialty pharmaceuticals. The Company has an extensive, diversified global supply chain supporting capabilities across nearly all dosage forms including solid oral dose, softgels, injectables, topicals, transdermals, inhalation, complex molecules and drug-device combinations, with R&D and manufacturing sites in the US, India and Ireland.
•  The Company expects to generate annual double-digit growth in net revenue, adjusted EBITDA and adjusted EPS over the next 3 years.
•  The Company expects to achieve significant annual cost saving opportunities of approximately $200 million within 3 years. The majority of the savings will result from the complementary nature of the companies' combined operations as well as margin-enhancing product transfer opportunities.


EudraLex - Volume 10 - Clinical trials guidelines
 Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials.
A number of documents in Volume 10 are being revised and updated to bring them in line with the changes required by the Clinical Trials Regulation (EU) No 536/2014. Additionally, new documents were prepared to cover new aspects introduced by the same Regulation.
In order to make a distinction between documents applicable to clinical trials authorised under Directive 2001/20/EC (i.e. the current applicable documents) and documents relevant to clinical trials authorised under Regulation (EU) No 536/2014, these documents will be listed in two separate pages on the Eudralex Volume 10 website.
Until the Clinical Trials Regulation becomes applicable sponsors should follow the documents relevant to the Clinical Trials Directive.
During the transitional period, which will last for a period of 3 years starting from when the Regulation becomes applicable, both sets of documents will apply accordingly and should be referred to respectively according to the legislation under which the Clinical trial is conducted.
At the end of the transitional period all clinical trials shall be conducted under the Regulation and should follow only the set of documents applicable to the Regulation.
Although it is not mandatory, stakeholders are encouraged to take already into consideration a number of aspects that are outlined in the new or updated documents published in the page dedicated to the Clinical Trial Regulation and apply them to those clinical trials authorised under the Directive, to the extent possible and in compatibility with the legal framework of the Directive.
For more information go to https://ec.europa.eu/health/documents/eudralex/vol-10/#fragment1


General Data Protection Regulation (GDPR)
The new EU General Data Protection Regulation (GDPR) is expected to apply in the UK from 25 May 2018. The detail of its application in the UK will be set out in a new Data Protection Act, which Parliament has yet to agree. Applicants should therefore not submit GDPR-related amendments at this time.
For health and social care research, the new Regulation is not very different from the current Act and the Health Research Authority will not be adding to the existing effective safeguards. In particular, Research Ethics Committee (REC) approval and the legal gateway for processing confidential patient information on the advice of the Confidentiality Advisory Group (CAG)  will continue, as will the other common law provisions. A summary of the key changes for all data processing (not just research) is available from the Information Governance Alliance.
The Information Commissioner’s Office has published resources for GDPR preparation, but they are not specific to research. Preparation guidance for research community is available from the Medical Research Council.
The HRA has published detailed guidance about operational arrangements that researchers and organisations may need to put in place.
We've also developed technical guidance intended for Data Protection Officers (DPO), research managers or information governance leads / security architecture leads, or equivalent. It may also be relevant for researchers. Some prior knowledge of terminology is assumed.
All guidance will be kept up to date in light of relevant national and European guidelines and the Data Protection Act 2018. As guidance becomes available, we will publicise it and link to it from this page.
Canary have two books available covering this subject which can be found at https://www.canarybooks.com/Data-Protection
An online training module is also available which can be found at https://www.brookwoodtraining-online.net/Data-Protection


MHRA will lose EMA work before Brexit transition period
Despite plans to continue its close wotk with the EMA, the MHRA will love involvement in evaluating medicines for the EU from March 2019.

The UK will lose its involvement in evaluating medicines for the European Medicines Agency (EMA) from the date it formally leaves the European Union in March 2019, despite plans for the UK to remain closely tied to the European Union (EU) during a transition period lasting until the end of 2020.

The EMA has appointed new rapporteurs and co-rapporteurs for 370 centrally authorised products where the UK’s Medicines and Healthcare Regulatory Agency (MHRA) and the Veterinary Medicines Directorate had co-ordinated post-authorisation work.
The new rapporteurs — who come from the other EU states plus Norway and Iceland — will take on full responsibility for the medicines on 30 March 2019, the day after the UK leaves the EU.
Despite post-Brexit transition plans the EMA said the MHRA could no longer engage in “centralised regulatory procedures” after 29 March 2019 unless another date for Brexit is agreed.

The MHRA said there has been no decision yet on the future relationship with the EMA. “We want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical innovations. We are committed to continuing a close working relationship with the European Medicines Agency,” it said in a statement. “This was reiterated further by the Prime Minister in her Mansion House speech of 2 March, where she confirmed the government would like to explore with the EU the terms on which the UK could remain part of EU agencies, such as the EMA.”
It said it is considering the impact of the EMA decision, but that most of its regulatory work is national rather than EU. It would not comment on whether it had requested that that work remain with it post-Brexit.
Niall Dickson, co-chair of the Brexit Health Alliance, which includes the Academy of Medical Royal Colleges, the NHS Confederation, and the Association of the British Pharmaceutical Industry among its members, said: “Our shared approach to regulation has given patients throughout Europe faster access to treatment. The UK has been a significant player in shaping the current system and now we are leaving the EU we accept that is bound to change.

“The EMA’s decision that the UK will no longer be leading work assessing new medicines, therefore, comes as no surprise. But we very much hope that the UK and EU will reach an agreement which will enable us to participate more fully. We believe that would be in the interests of both sides.
Work on licensing and monitoring medicines has been one of the first areas to be directly affected by Brexit. In November 2017, the 27 remaining EU member states took the decision to relocate the EMA headquarters from London to Amsterdam.
The Pharmaceutical Journal 16 APR 2018 By Alison Moore

Redistribution of UK’s portfolio of centrally authorised products

Assignment of new rapporteurs and co-rapporteurs completed

The EU27 Member States and the European Medicines Agency (EMA) have completed the reallocation of the medicines for which the United Kingdom’s (UK) Medicines and Healthcare products Regulatory AgencyExternal link icon (MHRA) and Veterinary Medicines DirectorateExternal link icon (VMD) are currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine.

Over 370 centrally authorised products have been transferred to new rapporteurs and co-rapporteurs from the EU27 Member States, plus Iceland and Norway, following a methodology developed by EMA’s working groups on committees’ operational preparedness for human and veterinary medicines.

The new (co)-rapporteurships will be communicated to the relevant marketing authorisation holders before the end of April.

The redistribution plan covers the post-authorisation stage in a medicine’s lifecycle, i.e. once a medicine has a marketing authorisation. It follows a multifaceted approach and takes into account both the diverse expertise in the European medicines regulatory network and the workload associated with each medicine. It allows Member States to participate in EMA activities according to their individual capacity.

The methodology used for the reallocation of medicines is based on Member States’ current expertise with a specific class of medicines. It also builds on existing knowledge, for example, by transferring medicines to the current co-rapporteur for a particular product, or to the peer reviewer involved in the marketing authorisation application.

In addition, the reallocation methodology takes into account the type of product. Generic medicines, for example, were allocated to national competent authorities who traditionally have participated less in EMA evaluations but have indicated that they would like to increase their involvement with such medicines. Clusters of products with the same international non-proprietary name (INN) and/or belonging to the same marketing authorisation holder have been allocated to a single rapporteur in order to facilitate review of post-authorisation procedures and ultimately improve efficiency within the network.

Further details are explained in a report.

EMA will facilitate the transfer of knowledge on the specific medicines from the UK to the new rapporteurs and co-rapporteurs once marketing authorisation holders have been informed of the changes. The new rapporteurs and co-rapporteurs will only take full responsibility for the re-allocated products as of 30 March 2019, when the UK withdraws from the European Union and becomes a third country.

EMA relocation to Amsterdam

On 20 November 2017, European Union (EU) Member States decided to relocate the European Medicines Agency (EMA) to Amsterdam, the Netherlands, as a result of the United Kingdom’s (UK) withdrawal from the EU. The Agency immediately began working with the Dutch authorities to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest.
EMA and the Netherlands have agreed a joint governance structure to steer and oversee the relocation project, with plans to progress activities within five work streams:
• temporary premises;
• permanent premises;
• staff relocation;
• financial and legal aspects;
• external communication.
Temporary and permanent premises
EMA's new permanent headquarters, a tailor-made building in the Zuidas business district of Amsterdam, are planned for completion on 15 November 2019.
The Dutch government will offer temporary premises to EMA, the Spark building in the Sloterdijk area of Amsterdam, from 1 January 2019 until its permanent building is completed.
This will allow EMA to gradually move all staff to Amsterdam before the end of March 2019 and ensure EMA’s business continuity in Amsterdam for the limited time until its new permanent building is ready.
On 28 February 2018, EMA's Management Board voted on a revised offer of the Dutch government regarding the Agency’s new permanent premises in Zuidas and endorsed the notification to the EU’s Budgetary Authority (comprising the European Council and European Parliament) of EMA’s intention to move to the new building.
EMA sent its notification to the Budgetary Authority on 2 March. The Budgetary Authority is expected to provide an opinion within four weeks.
This is a key step in the building approval process. EMA can only enter into a contractual obligation for its final premises if it receives a positive opinion from the Budgetary Authority

For more details on this story check out the EMA website at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_001893.jsp&mid=WC0b01ac0580cb2e5c


Boehringer teams up with OSE in €1.1 billion cancer drug partnership

Boehringer Ingelheim and biotech firm OSE Immunotherapeutics have announced that they have entered an exclusive collaboration and license agreement to develop the latter’s candidate for the treatment of advanced solid tumours. 

As part of the deal, Boehringer will obtain global rights to OSE-172, OSE’s SIRP-alpha antagonist, in exchange for an up-front payment of €15 million, followed by another sum of €15 million after the drug reaches Phase 1 trials. In its entirety, the deal is worth a potential €1.1 billion when development, commercialisation and sales milestones payments are taken into account.

OSE’s candidate is a monoclonal antibody which operates by targeting the SIRP-alpha receptor expressed in myeloid lineage cells, blocking the CD47 ligand from binding to the receptor and triggering its cellular inhibitory effects.

“We are excited to partner with OSE Immunotherapeutics to develop this promising, novel cancer immunotherapy,” commented Dr Jonathon Sedgwick, Global Head of Cancer Immunology & Immune Modulation Research at Boehringer Ingelheim. “A key area of focus is the identification of drugs that target myeloid cell immune regulatory receptors of which SIRP-alpha is a leading example. We are dedicated to developing ground-breaking, first-in-class therapies that can transform the lives of patients and help win the fight against cancer.”

OSE CEO Dr Dominique Costantini also added: “This partnership with Boehringer Ingelheim is a real recognition of the value of our innovative approach to treating cancer and will create an exciting new alliance to fuel the Phase 1 development of OSE-172. Boehringer Ingelheim’s expertise and insights will be invaluable as we step up the clinical development and work to commercialise this new treatment paradigm.”

EMA Management Board: highlights of March 2018 meeting

Board adopts 2017 report on veterinary medicines for minor use minor species and hears update on clinical trial portal and database

Increasing availability of veterinary medicines for minor use and minor species

At its 15 March meeting in London, the European Medicines Agency’s (EMA) Management Board endorsed the 2017 report on the implementation of the policy on veterinary medicines for minor use minor species (MUMS) / limited markets. The policy aims to stimulate the development of new veterinary medicines for minor species and for rare diseases in major species that would otherwise not be developed under current market conditions.

Stakeholders continue to be highly interested in the scheme. A total of 207 requests for classification as a MUMS medicine were received since the policy entered into force in 2009. 31% of the 29 requests received last year were submitted by small and medium-sized enterprises (SMEs).

The MUMS scheme foresees two types of incentives for developers: reduced data requirements and financial incentives for applications. It has proved successful in facilitating the authorisation of new treatments for animals, especially for food-producing species. In 2017, two MUMS medicines were recommended for marketing authorisation, including a product intended for the treatment of honey bees in hives infested with Varroa destructor and a bait vaccine for the immunisation of foxes and raccoon dogs against rabies.

Review of clinical trial portal and database

The Board received an update on progress with the development of the European Union (EU) portal and database. Based on the experience with this complex development so far, the developer has submitted a revised project plan with improved project management, development and testing processes and resources. It also contains increased contingency.

The Board heard that the first item (release 0.6) due under that plan has been received and has met the acceptance criteria. Further experience will enable greater confidence in the plan to be gained and an external party will also be asked to review this and report to the Board. The plan shows that release 0.7 should be available for audit, as required by Article 82 of the Clinical Trial Regulation, early in 2019. More precise information on timelines will be communicated after the audit.

Advanced therapies: achievements and challenges

Dr Martina Schüssler-Lenz, chair of EMA’s Committee for Advanced Therapies (CAT), also deputy head of advanced therapy medicinal products at the Paul-Ehrlich Institute (PEI)External link icon in Germany, presented the achievements and ongoing challenges in the area of advanced therapies, i.e. medicines that are based either on cells, genes or tissues. These medicines offer new treatment options for rare diseases and patients with high unmet medical need.

Ten advanced therapies have been granted an EU-wide marketing authorisation since the creation of the CAT in 2009. Four advanced therapies are currently under evaluation, including one cell-based and three gene-based therapies. In 2018, the CAT expects to start evaluating four additional medicines.

“We are observing rapidly evolving scientific and technical innovation entering the field of advanced therapies,” explained Dr Schüssler-Lenz, “but the Committee is well set up to cope with the scientific and regulatory challenges ahead due to its expertise and the way members interact and learn from each other.”

Dr Schüssler-Lenz also noted that requests for scientific advice for advanced therapies have increased significantly between 2012 and 2017 and that the CAT is now routinely involved in all scientific advice procedures for these medicines.

Monitoring of EMA independence policies

The Board reviewed the progress made during 2016 and 2017 with the implementation of the various Agency policies related to the independence of members and experts of EMA’s scientific committees, Management Board members and Agency staff. A report on independence covering 2016 and 2017 includes controls carried out during that time period. In line with the Agency’s commitment to continually review its operations, the report also identifies recommendations for further improvement and an action plan for 2018. The report will be made available on EMA’s website in due course.

Update on Brexit

The Board was informed that the dossier on EMA’s intention to move to its new permanent building in the Zuidas district of Amsterdam has been sent to the EU’s budgetary authority. The notification to the budgetary authority of EMA’s intention to move to new headquarters is required by the Agency’s financial regulation and is a key step in the building approval process.

The Board was also updated on the survey to marketing authorisation holders that EMA launched in January. The survey was sent to marketing authorisation holders of centrally authorised products (CAPs) who are located in the United Kingdom (UK) or who have quality control, batch release and/or import/manufacturing sites or a qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master files in the UK. The aim of the survey is to identify CAPs potentially at risk of supply shortages and to obtain information on the timelines for submission of the necessary regulatory changes. Responses received provided information on 90% of the medicines that were subject to the survey. The data are currently being analysed and a high-level summary of the results will be published.


EMA shares progress on Brexit preparations

At the EMA Management Board meeting in December 2017, the agency shared details of preparations for its move to The Netherlands and the operational arrangements for the UK’s withdrawal from the EU. This was the first meeting of the Board since the General Affairs Council of 20 November and the decision on the EMA’s relocation to Amsterdam. The agency now has just over a year to prepare, with a deadline of 30 March 2019 for taking up its new residence.
The agency reported that collaboration with The Netherlands commenced promptly and that agreement has been reached on the joint governance structure, with plans to progress activities within five workstreams:
• temporary premises
• permanent premises
• staff relocation
• financial and legal aspects
• external communication.
A delegation from the Dutch government attended the Management Board meeting and explained
how the Dutch authorities plan to meet the EMA’s requirements. While the Dutch authorities are committed to ensuring a seamless transition of the agency’s operations to its new location in Amsterdam, it is notable that the agency’s permanent new headquarters – the tailormade Vivaldi building – is not due for completion until November 2019.
The Dutch government will offer temporary premises to the EMA from 1 January 2019 (or earlier if requested) until the new building is ready.
The EMA and the Dutch authorities are working on a Memorandum of Understanding, and a
permanent Netherlands helpdesk has been set up within the EMA to offer guidance to staff on practical aspects to facilitate their relocation.
The Board was also informed that the EMA’s Brexit preparedness business continuity plan will enter Phase 2 in January 2018, in order to free up further resources that are needed to prepare for the UK’s withdrawal from the EU. Further details will be published within the EMA’s 2018 work programme.
 The EU27 (ie. all current Member States except the UK) and the EMA have developed a methodology
for the redistribution of work currently performed by the UK’s regulatory agency. The joint redistribution
plan reflects the strengthened capacity of the European medicines regulatory network, and the risk-based methodology takes into account the diverse expertise in the network and the workload associated with the medicines. More details will be communicated soon.

Guidance for companies
The EMA website now has dedicated pages on the agency’s relocation and the agency has published
a 9-page procedural guidance document to help pharmaceutical companies prepare for the UK’s withdrawal from the EU. The document outlines the practical and simplified requirements that
companies should follow when they apply for changes to marketing authorisations to allow for the continued marketing of their medicinesin the European Economic Area post-Brexit.

The guidance assumes that the UK will become a third country on 30 March 2019. It should be read in conjunction with the questions and answers published in May 2017 on the UK’s withdrawal from the EU within the framework of the centralised procedure. Key questions relating to medicinal products include the following:
• how can I submit an application for the transfer of a marketing authorisation for my products and
what would the applicable fees be?
• how will planned or ongoing regulatory procedures be handled during the transfer of a marketing
• is it possible to submit a transfer of the orphan designation in parallel with a transfer of the
marketing authorisation?
• is it possible to simplify transfer applications when these are Brexit-related?
• how can I submit a transfer or change in the name/ address of an orphan drug designation sponsor?
• how do I submit changes to the Qualified Person for Pharmacovigilance and/or changes in the
Pharmacovigilance Master File location?
• how do I submit changes to the person responsible for scientific services and to the person responsible
for batch recall and quality defects?

Marketing authorisation holders, applicants and sponsors of centrally authorised medicines should consider how Brexit will impact their medicines and which changes need to be addressed before the UK leaves the EU. They also need to ensure that the necessary changes are made by that date.
The EMA is preparing a series of additional Brexit-related guidances that will be published on its website. Companies are advised to regularly check the website for new information.


The International Council for Harmonisation (ICH) has proposed modernising the E8 Guideline in
order to incorporate the most current concepts, achieving fit-for-purpose data quality as one of the
essential considerations for all clinical trials.

The modernisation of the ICH E8 Guideline is the first step towards GCP renovation. The final
Concept Paper on the revision of the guideline (E8(R1)) was endorsed by the ICH Management
Committee on 14 November 2017. It notes that the E8 Guideline (‘General Considerations for
Clinical Trials’), which sets out general principles on the conduct of clinical trials, was adopted
in 1997 and has not previously undergone revision. Since 1997, clinical trial design and conduct have become more complex, and a wide range of trial designs and data sources that now routinely contribute to drug development are not adequately addressed in the original E8 Guideline.
Approaches for optimising trial quality, which promote the reliability, efficiency and patient focus of clinical trials, are needed. This involves identifying factors that are critical to the quality of a clinical trial at the design stage, and planning the trial conduct proportionate to the risks to these quality factors, thereby protecting human subjects and ensuring the reliability of trial results.
Specifically, the E8 Guideline has high-level descriptions of trial objectives and design but does not address how design or planning considerations can optimise trial and data quality. Moreover, the set of trial designs described in the E8 Guideline is limited and does not reflect today’s best practice.

To resolve these issues, E8(R1) will

• identify a basic set of critical-to-quality factors (eg. eligibility criteria, masking, types of controls,
outcome ascertainment, site feasibility, safety monitoring, statistical analysis, and investigational
product handling and administration) that can be adapted to different types of trials to support the
meaningfulness and reliability of trial results and protect human subjects

• address a broader range of trial designs and data sources

• provide an updated comprehensive guide to, or cross-referencing of, all other relevant ICH
guidelines that inform the design, planning and conduct of clinical research, without reproducing
the detailed material foun

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