What's New

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 found in those guidelines.

The plan for E8(R1) is an outcome of the ICH Reflection Paper ‘“GCP Renovation”:
Modernization of ICH E8 and Subsequent Renovation of ICH E6’, which outlined an
approach to renovating and modernising the ICH guidelines related to clinical trial design, planning, management, conduct and reporting.
The proposed revision will include a review of the issues and questions that are most critical to clinical
trial quality and the ability of a trial to achieve meaningful and reliable results. Additionally, E8(R1) will incorporate the most current guidelines for achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials, including the broad range of trial designs and data sources currently in use.
The revision of the ICH E8 Guideline is expected to enhance the reliability of trial results through
attention to trial quality. It will also

• better integrate the overall design and planning with subject protection and data reliability
considerations that are the focus of the ICH E6 Guideline, statistical considerations that are the focus of the ICH E9 Guideline, and other considerations addressed in other ICH efficacy guidelines

• enhance the utility of the ICH efficacy guidelines by including critical-to-quality factors as a key
consideration in trial planning and design

• promote the quality of trial design and conduct for a broad range of trial types and data sources
with critical-to-quality factors aligned to the objectives of the trial.

Following E8(R1), the ICH Reflection Paper proposes the updating of the ICH E6(R2) Guideline on Good Clinical Practice, to address the increasing diversity of trial designs and data sources.
The project, which began in September 2017, is expected to be completed by 2021. With the final Concept Paper now approved, it is anticipated that the Step 2b Guideline will be completed by Q1 2019, following further face-to-face meetings of the Expert Working Group in June and November 2018.
A meeting with stakeholders will be held to discuss the Step 2b document, possibly at the end of the public consultation period.


BIA reacts to announcement from European Commission President Jean-Claude Juncker and Prime Minister Theresa May this morning [8 December] that ‘sufficient progress’ has been agreed on phase one of the Brexit negotiations.

CEO, Steve Bates, said: “We welcome today’s agreement. It is now crucial that the UK and EU agree a transition period to ensure that the supply of medicines to patients in the UK and across Europe is not affected. Public health and health security should be the first priority for the second phase of talks and we stand ready as a unified life science sector to provide expert input on such a process.
"On the detail, greater certainty in key areas proposed is welcome. I hope the citizens rights proposals enable people to better plan their life science careers with their families. My initial reading of the ‘goods on the market’ proposals is that it should enable medicinal products that have been tested and released prior to the Brexit date (which may well now be later than March 2019) to be freely available in the EU, even if that testing and release is carried out in the UK and the goods are shipped to other EU countries after the UK withdraws. This is important detail for global companies deciding how, and crucially when, to progress existing Brexit contingency plans."

BIA CEO Steve Bates responds to the announcement of the Life Sciences Sector Deal
Responding to today’s announcement of the Life Sciences Sector Deal, BIA CEO, Steve Bates, said: “It is fantastic that the life sciences are the first sector to have a deal published and this document showcases a range of investment in to the industry and partnerships working across this exciting and entrepreneurial industry. BIA members are particularly prominent in advanced therapies manufacturing and genomics.
“The sector deal shows government commitment to the agenda we have long led on access to finance, support for start-up and scale-up businesses, Innovate UK funding and medicines manufacturing. The BIA will be involved in the implementation of the deal as a clear voice for small businesses and I look forward to engaging in the planned funding and review next year.”
Many BIA members are also highlighted directly in the sector deal, showing the increasing strength and importance of the UK bioscience sector:
• Oxford BioMedica’s lentiviral vector platform technology has been endorsed by the FDA through approval of Novartis’s CAR-T cell therapy product, Kymriah™. Continued growth is assured through recent regulatory filings by Novartis in both Europe and in the United States, and with additional OXB strategic partnerships with other organisations, including Orchard Therapeutics.
• Touchlight Genetics is expanding operations at Hampton, London, with a Good Manufacturing Practice (GMP) facility to synthetically manufacture commercial-scale DNA (for gene therapy/gene editing/DNA vaccines) in two weeks, disrupting decades old fermentation approaches.
• Adaptimmune, with its pipeline of T-cell therapies to treat cancer, has to date raised over £300m and invested in new facilities for its growth and has over 200 UK employees. In 2017 alone it raised $100m
BIA members will recognise many of the announcements from meetings and discussions at BIA events and forums throughout 2017:
• The Medicines Manufacturing Industry Partnership (MMIP) has led on the key initiatives and catalysing major investments in new facilities
• The Finance and Tax Advisory Committee has shaped the BIA’s input into the Patient Capital Review, which forms the business environment finance commitments in the deal
• £86m investment to support SMEs through the Accelerated Access Review was announced at the BIA’s joint conference with the MHRA in July
• BIA members have shaped the BIA’s policy calls for the industrial strategy through surveys, interviews and a dedicated workshop in March 2017  
You can read the full sector deal document here: https://www.gov.uk/government/publications/life-sciences-sector-deal

About the UK BioIndustry Association (BIA)
Established over 25 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives.

For further information, please go to www.bioindustry.org and twitter.com/BIA_UK



A Guide to GCP for Clinical Data Management
A brand new book for data management teams. Written by experienced head of data management, Mark Elsley, in conjunction with Professor David Hutchinson.
This book covers the key ICH GCP E6(R2) requirements relevant to members of the data management team. It also provides valuable practical advice gained from the author’s extensive experience in this field.

Content is based on a GCP checklist providing more detail on the following general requirements
• Ensure that staff are suitably qualified and trained
• Create, maintain and follow sops describing the clinical data management processes
• Validate and control all computerized systems used to collect and handle clinical data
• Ensure that the flow of data from the source to the database is well documented
• Ensure that source data meet ALCOA+ standards
• Create a user-friendly CRF and database
• Check CRF data for accuracy, consistency and completeness
• Produce, maintain and archive high-quality documentation
• Ensure that CROs are suitably qualified and experienced
• Use a risk register at functional and study level
• Have input into risk-based approaches to trial management

The book includes a GCP checklist for clinical data management and supports an online training course on the same subject.

UK government unveils pharma research HQ coup

The UK government’s Autumn Budget struck a gloomy note for the economy, with figures pointing towards low productivity and the likelihood of slowing growth in the years to come.

With Brexit negotiations progressing at a snail’s pace, the government needed a boost to show that its economic plans were proving fruitful and they have released news that will allow them to claim some success.

This comes in the form of MSD’s investment in a research hub in the UK, with the company (known as Merck in North America) pumping up to £1 billion into the facility and creating 950 roles to staff the facility. The “Discovery Centre” will be based in London and the company hopes to have the facility ready by 2020.

Greg Clark, UK Business Secretary, heralded the move as a mark of the UK’s ability to draw investment: “Our life sciences sector is one of the UK’s fastest developing industries, with a turnover in excess of £64 billion, employing 233,000 across the UK. MSD’s commitment today, and the wider Sector Deal investment we have secured, proves the process outlined in the Industrial Strategy can give companies the confidence and direction they need to invest in the UK. It will ensure Britain continues to be at the forefront of innovation and represents a huge vote of confidence in our Industrial Strategy.”

The UK government has touted the life sciences industry as one that can drive growth, regardless of the outcome of negotiations. Admittedly, this angle sustained a blow almost immediately after the Brexit decision – when it became clear that the EMA headquarters would be leaving London, settling on Amsterdam as its preferred location.

However, it seems that the UK government has scored several successes in encouraging life sciences companies to invest in the UK – with further announcements expected over the next few weeks signposting the country’s competitiveness in the field. One is expected from GSK, one of the big two pharma companies that calls the country its home – the other being AstraZeneca.

“We believe London to be a unique bioscience centre of excellence and a key component of the established golden triangle for academic science of London-Oxford-Cambridge,” said Louise Houson, Managing Director of MSD in the UK and Ireland. “This investment presents a major opportunity for us to work in collaboration with the UK Government to build on the forward thinking and ambitious Industrial Strategy White Paper published by the Government today.”

Alongside the announcement of MSD’s facility, there was also the announcement that Qiagen, a provider of sample and assay technologies for molecular diagnostics, would also build a facility in Manchester. This would also provide a boost of 800 roles, through the development of a genomics campus

Amsterdam wins bid to host EU medicines agency post-Brexit

Amsterdam has won a vote to host the European Medicines Agency (EMA) which will relocate from London after the UK leaves the European Union.
The UK is losing both the EMA and the European Banking Authority (EBA) which employ around 1,000 people.
Ministers from the 27 EU countries remaining in the bloc after the UK departs in 2019 have taken part in the secret ballot.
They will now vote later on the new home for the EBA.
Some 16 cities bid for the EMA, while eight want to host the EBA - Brussels, Dublin, Frankfurt, Paris, Prague, Luxembourg City, Vienna and Warsaw.
The EMA is the more alluring of the two bodies, as it promises to make its new host into a hub for Europe's medical industry.

Update in Clinical research & GCP – Copenhagen 23rd October 2017
Refreshments & Registration from 8.30am

• EU Clinical Trial Regulation 2014 No. 536
A brief overview of the finalised Regulation awaiting implementation

• Risk proportionate approaches in clinical trials
Summary of the latest EMA Recommendations

• Pharmacovigilance update
Inspectors want to see that all staff have some basic PV knowledge. This session will
provide an update on what’s new as well as to provide some PV basics.

• Inspection expectations for the Trial Master File
Highlights of the EMA’s Trial Master File draft Reflection Paper

• Q&A using keypads on the draft EMA Serious breaches guideline

• EMA First-in-Human Guidance
A summary of EMA’s 2017 guideline on first-in-human studies

• Latest news on what’s coming and new
Including: AxMPs, modernization of ICH E8 and its knock on impact on ICH GCP E6,
Delegated Regulation on GMP affecting

Check out the website at www.brookwoodacademy.org to book a place



EU Clinical Trials Regulation: an update

Despite early promise that the EU Clinical Trials Regulation (No. 536/2014) might have been implemented in May 2016, it is now clear that it will not come into operation until 2018.

The Regulation aims to create an environment that is favourable for conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information.
The Regulation will harmonise the assessment and supervision processes for clinical trials via an EU
portal and database, set up and maintained by the European Medicines Agency (EMA) in collaboration with Member States and the European Commission.
Consequently, the rate-limiting step for implementing the Regulation has always been confirmation of the full functionality of the portal and database through an independent audit.

The EMA’s current delivery timeframe indicates that the EU portal and database should be available for independent audit by August 2017. If the systems pass the audit, the Regulation will come into effect by October 2018.

Lengthy transitional period
Assuming that the Regulation does come into effect in October 2018 – and the EMA states that it is doing everything possible to bring this date forward – there will be a 3-year transition period until October 2021, during which there will be an overlap of the new Clinical Trials Regulation with the Clinical Trials Directive 2001/20/EC:
• from October 2018 to October 2019, applications for clinical trials may be submitted under either the new Regulation using the EU portal and database or under the current Directive using the EudraCT database
• from October 2019 to October 2021, only clinical trials authorised under the Directive will continue to be governed by that Directive
• from October 2021, any ongoing trials that were originally authorised under the Directive will
fall under the new Regulation and will be governed accordingly.

ICH GCP E6 (R2) is born
The new ICH GCP guidelines including the Integrated Addendum E6 (R2) have finally been published and are now available to view in the ICH website at:
Here at Canary we have been busy rewriting our own version of the guidelines with a copyrighted index which allows users to search for the appropriate sections using subject index and key words.
It is ideal for investigators, monitors, auditors, regulatory authority inspectors, members of ethics committees and others who need regular access to the GCP guidelines. Prices start from as low as £3 per copy. For more details see our website at www.canarybooks.com. Our publication is available as a handy pocketbook or larger format A5 desk version.


Need a short course to update your staff on the new ICH GCP Guidelines Addendum E6 R2 ?
November 2016 marks a milestone in GCP history when the proposed changes to the ICH GCP guidelines in addendum R2 are signed off as a Step 4 document.

This course will cover the changes the addendum brings and its impact for sponsors and investigators.
The short course will include:

Online .......... On Demand .......... Global ..........
Take the course at a time to suit you.
ONLY £30 per participant

To Book online visit:



Hot news from 2nd European QA Conference in Nice

FDA has acceptance of e Consent and published guidance. Concept not so acceptable in EU. See next issue of Advisor
eTMF guidance from EMA IWG is due out for consultation in 5-6 weeks. Gabrielle Schwartz - Head of GCP inspection Germany

Poor publication and reporting rates for trials at US academic medical centres

Researchers in the USA have assessed the rates of publication and reporting of clinical trial results by leading academic centres. The primary outcome measure was the proportion of trials that disseminated results – defined as publication or reporting on <ClinicalTrials.gov> – both overall and within 24 months of study completion. The assessment focused only on academic medical centres that had 40 or more completed interventional trials registered on <ClinicalTrials.gov>, and on clinical trials with a primary completion date between October 2007 and September 2010. In addition, the lead investigator had to be affiliated with an academic medical centre.
The study findings were reported in <I>BMJ</I> and can be summarised as follows:

l among 4347 interventional clinical trials from across 51 academic medical centres, 1005 (23%) enrolled more than 100 patients, 1216 (28%) were double-blind and 2169 (50%) were Phases II to IV
l academic medical centres disseminated results for 2892 (66%) trials, with 1560 (36%) achieving this within 24 months of study completion
l the proportion of clinical trials with results disseminated within 24 months of study completion ranged from 16% (6/37) to 55% (57/103) across the centres
l the proportion of clinical trials published within 24 months of study completion ranged from 11% (4/37) to 40% (31/77) across the centres, whereas results reporting on <ClinicalTrials.gov> ranged from 2% (2/122) to 41% (72/177).

The authors concluded that, despite best intentions, over the period of evaluation there was poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centres in the USA.

Source: </I>BMJ<I> 2016;352:i637, <http://bit.ly/1OhXlaf>

[original source www.bmj.com/content/352/bmj.i637]

EGA becomes Medicines for Europe

The European Generic and Biosimilar Medicines Association (EGA) has become Medicines for Europe. The new body has highlighted the importance of both generic and biosimilar medicines to European healthcare. The generic and biosimilar industries currently supply the majority of Europe’s prescription medicines, and this contribution is estimated to reach 75% in volume over the next 5 years. The repositioning of the EGA as Medicines for Europe aims to drive greater healthcare efficiency through better health outcomes, while providing solutions for the sustainability of European healthcare systems facing increased demographic demands on healthcare services.
Adrian van den Hoven, Medicines for Europe Director General, stated, “Medicines for Europe is a great opportunity to build on the EGA’s established reputation for partnership with stakeholders and authorities to deliver access to high quality medicines for patients, its commitment to the highest levels of quality, and to bringing even more value to pharmaceuticals while bridging the sustainability of healthcare with a competitive pharmaceutical manufacturing industry.”

Source: <http://bit.ly/1SCN93b>

[original source www.medicinesforeurope.com/news/ega-becomes-medicines-for-europe/]

Update Seminar in Clinical Research & GCP

As part of the pre-conference training at the European QA conference Brookwood Academy are pleased to offer:
 An Update Seminar in Clinical Research & GCP
 Tuesday 26th April 2016 Nice Acropolis, Nice, France

Ideal update and refresher consisting of executive summaries of the latest developments and discussion of clinical research topics to satisfy ongoing training needs.

Course Content Includes:
• Impact of the revision to the ICH GCP guidelines E6 R2

• Overview of the new EU Clinical Trial Regulation No.2014/536

• GCP update and refresher – an interactive Q&A on GCP questions and problems

• Consent in clinical trials – GCP requirements, individualising consent and testing knowledge

• Serious breaches – understanding the new reporting requirement with case studies

This seminar is suitable for those who need to update their general knowledge and to demonstrate recent and up-to-date training: those overseeing or actively managing clinical trials as sponsors, monitors, auditors, investigators, supervisors and administrators; academics; those responsible for research governance, members of ethics committees and site personnel involved in both commercial and non-commercial trials covered by European legislation

Price: €350 per person for bookings made until 31st March 2016 €450 per person thereafter. Discounts for groups can be negotiated. Book early to avoid disappointment as places are limited
 Bookings can be made online at https://brookwoodacademy.org/Update-and-Refresher-Course-in-Clinical-Research-and-GCP
 Bookings for the seminar may also be made by email at info@brookwoodacademy.org or by calling (from UK) 01483 811383; from elsewhere +44 1483 811383
 An invoice will be issued. Your place will be confirmed once payment has been received. Cancellations not permitted but the named participant may be replaced at any time.


MHRA releases latest annual pharmacovigilance inspection metrics

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has summarised the findings of
inspections performed by the Good Pharmacovigilance Practice (GPvP) Inspectorate in the 12 months to
March 2015.


FDA issues draft best practice guidance

New draft guidance describes best practices for communication between the FDA and sponsors of investigational new drug applications (INDs). Published in the Federal Register on 9 December 2015, the new guidance aims to facilitate the earlier availability of safe and effective drugs to the US public. It recommends procedures for timely, transparent and effective communication between IND sponsors and the FDA at critical junctures in the drug development process.

The document details
• FDA philosophy on timely interactive communication with IND sponsors
• the scope of appropriate interactions between the review team and the sponsor
• the types of advice appropriate for sponsors to seek from the FDA in pursuing their drug development programme
• general expectations for the timing of FDA responses to sponsor enquiries
• best practices and communication methods to facilitate interactions between the FDA review team and the IND sponsor
• the expectations for appropriate methods for such communication, including their frequency.

The draft guidance is available for a 60-day consultation period until 8 February 2016.


Latest Clinical Trials Regulation timeline

At a meeting on 16–17 December 2015, the European Medicines Agency’s (EMA’s) Management Board formally adopted the agency’s multi-annual programme and work plan for 2016.

Details of the EMA’s work programme for 2016 will be published in the first quarter of 2016, but a few highlights are already available. The agency has also made the following forecasts on key medicines development activities:

• the level of pre-authorisation activities for human medicines is expected to be stable, with
around 546 requests for scientific advice in 2016 compared with 510 in 2015

• approximately 33 requests for parallel advice with heath technology assessment bodies are expected

• the number of applications for initial marketing authorisation is expected to remain constant, with
110 applications in 2016 compared with 112 in 2015

• the number of applications for medicines containing a new active substance should also remain stable.

EU clinical trial portal and database

The agency’s multi-annual programme makes reference to the EU clinical trial portal and database,
the single portal for the submission and maintenance of clinical trial applications and authorisations that will underpin the new European Clinical Trials Regulation. The portal and database will also serve as the source of public information on the full lifecycle of all clinical trials conducted in the EU.
It is critically important that the EU system provides the required functionalities for all stakeholders in the most efficient and stable way possible from the outset, so as to ensure the delivery of the broad-reaching benefits foreseen by the Clinical Trials Regulation.

The following timeframe for the implementation of the portal and database was endorsed at the
Management Board meeting, and outlined in an EMA notification on 17 December 2015:

• independent audit: August – November 2017

• audit endorsed by EMA Management Board: December 2017

• European Commission notice published in the Official Journal of the European Union: March 2018

• Production Version completed: July 2018

• Production Version available: September 2018

• Clinical Trials Regulation (EU) No. 536/2014 becomes applicable: October 2018.

The new Clinical Trials Regulation entered into force on 16 June 2014. At that time it was stated
that the Regulation will apply no earlier than 28 May 2016, so for many the new October 2018 date may seem surprisingly far away. The agency is keen to stress that the current timeframe includes
provision for the resolution of unforeseen difficulties and potential issues (ie. it is considered to be a
maximum), and that all possible efforts will be made to bring the Regulation into operation earlier.



Revision to CIOMS Ethical Guidelines for Biomedical Research

The Council for International Organizations of Medical Sciences (CIOMS) has published online the revised draft of its Ethical Guidelines for Biomedical Research, with a deadline for comments of 1 March 2016.
A CIOMS Working Group has been working on a revision of the 2002 CIOMS Ethical Guidelines for Biomedical Research since 2012, looking at recent developments in the fields of biomedical research and research ethics, most notably the revised Declaration of Helsinki of 2013. Most of the original guidelines have been substantially revised, and several guidelines have been added to address new issues that require ethical guidance (eg. disaster research). In addition, the ‘Green Book’ (CIOMS Guidelines for Biomedical Research, 2002) and the ‘Blue Book’ (CIOMS Guidelines for Epidemiological Research, 2009) have been merged as they overlap substantially. The scope of the guidelines has also been broadened from biomedical research to health-related research with humans. Thus there are now 25 individual guidelines covering a broad range of topics, including the following:

• research in low-resource settings
• the equitable distribution of benefits and burdens in the selection of research participants
• the potential benefits and risks of research
• the choice of control in clinical trials
• caring for participants’ health needs
• community engagement, and collaborative partnership and capacity building for research and review
• individual informed consent, modifications and waivers of informed consent
• the use of stored biological materials and related data, and health-related data
• reimbursement and compensation for participants
• treatment and compensation for research-related harm
• research involving vulnerable persons, individuals who are not capable of giving informed consent, children and adolescents
• women, pregnant women and lactating women as research participants
• research in disaster situations
• implementation research
• research ethics committees and review
• public accountability
• conflicts of interest.

Source: <http://bit.ly/1YV44A6>

[original source www.cioms.ch/index.php/guidelines-test]


EMA position paper aims to reinforce compliance with GCP

The European Medicines Agency (EMA) has issued a Position Paper explaining that it will permit  the replacement of a pivotal clinical trial that has been found to be non-compliant with GCP by another study, in the context of a marketing authorisation application. This position aims to reinforce the application of GCP during the conduct of clinical trials.
In the EU all clinical trials submitted to a regulatory authority to support a marketing authorisation application must be compliant with GCP, in order to ensure that the rights, safety and well-being of trial subjects and the integrity of trial data are protected.
In the event that a clinical trial is found to be non-compliant with GCP during an inspection relating to a marketing authorisation application, the applicant may respond to the inspection findings, provide a re-analysis of the data or provide a justification of why it believes the data are reliable. The EMA’s Committee for Medicinal Products for Human Use will take these representations into account during its assessment of the benefits and risks of the medicine. However, the new Position Paper makes it clear that the EMA will not allow a non-GCP compliant pivotal study to be replaced by another study during the assessment of the application.
Applicants may still submit a new application for marketing authorisation for the same medicine supported by appropriate GCP-compliant data from a pivotal study.

Source: <http://bit.ly/1QuXw8V>

[original source www.ema.europa.eu/docs/en_GB/document_library/Other/2015/11/WC500197332.pdf]


New EU trade and investment strategy to boost access to medicines

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the European Commission’s new trade and investment strategy for the EU as “a comprehensive means of addressing existing barriers to trade in a constructive and inclusive manner”.
In its statement on 15 October 2015, the EFPIA explained that it believes the new strategy – ‘Trade for all: towards a more responsible trade and investment policy’ – will enable the pharmaceutical industry to operate in a more transparent and predictable environment, by removing trade barriers and eliminating regulatory hurdles in third countries while increasing market access. In addition, it should reduce production costs and generate cost savings, which may then be re-invested into research and development and improving the regulatory environment. Such changes have the potential to boost medicines innovation and accelerate patient access to new treatments.
EFPIA Director General Richard Bergström said, “We welcome the new trade strategy of the Commission and the renewed impetus for dialogue and negotiations with key strategic partners such as US, China and Turkey as well as the resumed focus on the ASEAN [Association of Southeast Asian Nations] region. This will not only create a level-playing field for our companies, but will also offer opportunities for medicines innovation and faster access to treatments for patients

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