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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdEU updates
The following articles on this topic have been published in
CRAdvisor (CRA) – the year, issue number
and starting page number for each are listed below:
Back to index |
| 2007 |
|
|
CRA 2007; 183:6 |
French government fixes duration of biomedical trial document archiving. |
|
CRA 2007; 184:1 |
Final version issued of Volume 9A on human pharmacovigilance in the EU. |
|
CRA 2007; 184:2 |
EU Paediatric Regulation 1901/2006 now in force. |
|
CRA 2007; 184:8 |
MHRA and ASPRs. |
| CRA 2007; 186:3 |
MHRA modifies process for first-in-man studies. |
| CRA 2007; 186:6 |
EU drug review times. |
| CRA 2007; 189:3 |
Steps taken to strengthen EU pharmacovigilance. |
| CRA 2007; 189:7 |
Further changes to Volume 9A on pharmacovigilance in
humans. |
| CRA 2007; 191:4 |
EC guidance on IMPs and non-IMPs. |
| CRA 2007; 193:8 |
Repackaging and trademark rights. |
| CRA 2007; 194:2 |
EU regulation on advanced therapies. |
|
CRA 2007; 194:8 |
Templates for the EU Paediatric Regulation. |
|
CRA 2007; 194:8 |
EU-US regulatory co-operation. |
|
CRA 2007; 195:7 |
New trial requirements in Poland. |
| |
|
| 2006 |
|
|
CRA 2006; 163:1 |
EC adopts modified proposal for a regulation on medicines for children. |
|
CRA 2006; 163:10 |
Volume 9a for public consultation. |
|
CRA 2006; 163:10 |
Pharmacovigilance UK-specifics. |
|
CRA 2006; 164:2 |
Modifications to proposed EC paediatric regulations. |
|
CRA 2006; 164:3 |
Pharmacovigilance for vaccines. |
|
CRA 2006; 165:1 |
New on-line application forms mandatory in The Netherlands from 1 March
2006. |
|
CRA 2006; 167:2 |
Standard clauses for data transfer are underused says EC report. |
| CRA 2006; 167:7 |
EMEA prepares for Bulgaria and Romania as Member States. |
|
CRA 2006; 168:1 |
EU revises Detailed Guidance on ethics committee applications. |
|
CRA 2006; 168:3 |
European experience with orphan drug development. |
|
CRA 2006; 168:8 |
International co-operation on medicines regulation intensified. |
|
CRA 2006; 169:2 |
EC issues revised Detailed Guidance on ethics committee applications. |
|
CRA 2006; 169:7 |
Draft pharmacovigilance guideline on monitoring of compliance with
obligations and inspections. |
|
CRA 2006; 169:7 |
Assessment of the EU pharmacovigilance system. |
|
CRA 2006; 169:8 |
Common position reached on the paediatric regulation. |
|
CRA 2006; 169:8 |
Cooperation on medicines regulation intensified. |
|
CRA 2006; 170:1 |
European Commission, not EMEA. |
|
CRA 2006; 170:8 |
Pharmaceutical industry restricts trial information being made public. |
| CRA 2006; 171:1 |
France implements trials Directive 2001/20/EC. |
| CRA 2006; 171:7 |
France and Sweden link with FDA. |
| CRA 2006; 172:6 |
EU issues guidance for comment on direct healthcare
professional communications. |
| CRA 2006; 172:7 |
Commission allows early authorisation for emergency
medicines. |
| CRA 2006; 174:4 |
Impact of EU Directive 2001/20/EC in Central and Eastern
Europe. |
| CRA 2006; 174:5 |
Pharmacovigilance obligations in Europe. |
| CRA 2006; 176:2 |
European Commission publishes first draft of Notice to
Applicants, Volume 10, on clinical trials. |
| CRA 2006; 176:9 |
New EU guidance on specific modalities for non-commercial
studies. |
| CRA 2006; 177:8 |
Panel and forum to discuss future challenges. |
| CRA 2006; 178:8 |
New law relating to ethics committees in Italy. |
|
CRA 2006; 179:1 |
Implementation of the Paediatric Regulation. |
|
CRA 2006; 179:6 |
Update on compassionate use in Europe. |
|
CRA 2006; 182:7 |
IMP or non-IMP? |
| |
|
| 2005 |
|
| CRA 2005; 143:1 |
Increase in paediatric research in USA and Europe predicted for 2005. |
| CRA 2005; 143:3 |
Conference on children's medicines. |
| CRA 2005; 144:7 |
EU assessment of pharmacovigilance system. |
| CRA 2005; 145:4 |
Is the Swedish Act on biobanks in medical care applicable to clinical
trials? |
| CRA 2005; 146:7 |
Latest on new clinical trials law in The Netherlands. |
| CRA 2005; 146:7 |
EU proposals for penalties. |
| CRA 2005; 146:7 |
Clarification on borderline products. |
| CRA 2005; 147:8 |
Authorisations for manufacturing and import. |
| CRA 2005; 148:4 |
Amendment to UK trials legislation to enable studies in emergency
medicine. |
| CRA 2005; 148:4 |
Penalties and sanctions for breaches of Italian clinical trial law. |
| CRA 2005; 153:5 |
MHRA business plans. |
| CRA 2005; 153:5 |
EU human tissue engineering. |
| CRA 2005; 154:4 |
EC consultation on regulation of paediatric medicines. |
| CRA 2055; 155:5 |
UK report on the influence of the pharmaceutical industry |
| CRA 2005; 156:7 |
Luxembourg's new clinical trial law. |
| CRA 2005; 157:1 |
Amendments proposed to awaited clinical trials law in The Netherlands. |
|
CRA 2005; 159:2 |
FDA issues draft guidance on complying with the Pediatric Research Equity
Act. |
| CRA 2005; 161:5 |
Regulatory approval in Denmark. |
| CRA 2005; 162:1 |
The Netherlands to implement new clinical trials law in
March 2006. |
| CRA 2005; 162:8 |
Public access to Italian trials registry. |
| |
|
| 2004 |
|
| CRA 2004; 123:1 |
Investigator challenges EMEA in attempt to overturn new product marketing
approval. |
| CRA 2004; 124:4 |
Changes proposed in Netherlands. |
| CRA 2004; 124:4 |
New EU guidelines and regulations. |
| CRA 2004; 125:2 |
New employment trends in European clinical research. |
| CRA 2004; 126:2 |
European action plan to improve medicines. |
| CRA 2004; 126:6 |
Royal College wants more clinical research. |
| CRA 2004; 126:7 |
Danish notification of clinical trials. |
| CRA 2004; 127:7 |
Spain and Greece implement new clinical trial legislation. |
| CRA 2004; 127:7 |
New EU disease control centre. |
| CRA 2004; 127:8 |
Impact of EU price controls. |
| CRA 2004; 127:8 |
UK's transitional guidance for herbal products. |
| CRA 2004; 127:8 |
Mock application for a fictitious biotechnology product. |
| CRA 2004; 128:6 |
Draft EU regulation on medicinal products for paediatric use. |
| CRA 2004; 129:3 |
EC proposes regulation to increase products approved for paediatric use. |
| CRA 2004; 129:4 |
Commission proposal on medicines for paediatric use: rationale and overview. |
| CRA 2004; 129:7 |
Manufacturer's authorisation for investigational medicinal products. |
| CRA 2004; 129:7 |
EU and US harmonise approval times. |
| CRA 2004; 132:1 |
European Medicines Agency is born as EU introduces new pharmaceutical
legislation. |
| CRA 2004; 132:4 |
New law and labelling requirements in Belgium. |
| CRA 2004; 132:4 |
German Bundesrat objects to drug law proposals. |
| CRA 2004; 132:4 |
Independent contact point in The Netherlands has to be physician. |
| CRA 2004; 132:4 |
Novartis rated as top sponsor. |
| CRA 2004; 132:5 |
The EC-Japan MRA. |
| CRA 2004; 132:5 |
Study to assess European pharmacovigilance. |
| CRA 2004; 132:5 |
Revision of Annex 1 of EC GMP. |
| CRA 2004; 132:5 |
Statement on the Qualified Person's discretion. |
| CRA 2004; 133:7 |
CHMP holds first meeting. |
| CRA 2004; 134:1 |
Directive watch. |
| CRA 2004; 135: 1 |
Long-awaited Commission Directive on GCP released for consultation. |
| CRA 2004; 135:4 |
German drug law passed. |
| CRA 2004; 135:6 |
Guide to new trial regulations in The Netherlands. |
| CRA 2004; 137:10 |
Germany implements new drug law. |
| CRA 2004; 137:11 |
Information on meetings to gain advice from the UK's MHRA. |
| CRA 2004; 139:1 |
FDA inspections reveal quality improvement in European trials. |
| CRA 2004; 139:6 |
New clinical trial law in Portugal but further delays to Dutch law. |
| CRA 2004; 140:2 |
EC proposes regulation on paediatric medicines. |
| CRA 2004; 140:6 |
Update to guide for orphan products. |
| CRA 2004; 140:7 |
The demands of language in the expanded EU. |
| CRA 2004; 140:7 |
Translations for new EU states. |
| CRA 2004; 141:1 |
EU regulation proposed for promoting medicines for children. |
| CRA 2004; 141:6 |
Estonian clinical trial laws. |
| CRA 2004; 141:6 |
New clinical trial law in Slovakia takes shape. |
| |
|
| 2003 |
|
| CRA 2003; 102:6 |
Updates to EU centralised procedures. |
| CRA 2003; 102:6 |
Products should have single name in EU. |
| CRA 2003; 102:8 |
Devices could face drug regulation compliance. |
| CRA 2003; 103:8 |
New medicines compendium. |
| CRA 2003; 103:8 |
EU review of pharmaceutical law. |
| CRA 2003; 104:8 |
Latest European regulatory activities. |
| CRA 2003; 104:8 |
MCA appoints GDP inspectors. |
| CRA 2003: 105:5 |
Primary and community care research management and governance. |
| CRA 2003; 105:6 |
Publishing trial data: the industry responds. |
| CRA 2003; 107:4 |
Research Governance Implementation Plan: target date for sponsors changed to
April 2004. |
| CRA 2003; 108:6 |
New Agency for UK. |
| CRA 2003; 108:6 |
CPMP adopts new documents. |
| CRA 2003; 115:5 |
Council of Europe publishes draft additional protocol on biomedical
research. |
| CRA 2003; 115:6 |
2003 Pharmaceutical data. |
| CRA 2003; 117:8 |
EU regulations to encourage centralised marketing authorisation
applications. |
| CRA 2003; 117:8 |
CPMP guidance on appendices of clinical study reports within marketing
applications. |
| CRA 2003; 118:4 |
Implications of EU expansion. |
| CRA 2003; 119:7 |
Overview of the European pharmaceutical industry. |
| CRA 2003; 119:7 |
Professor Kent Woods appointed Chief Executive of MHRA. |
| CRA 2003; 121:6 |
EC supports formation of a European Research Council. |
| |
|
| 2002 |
|
| CRA 2002; 86:6 |
Leading UK cancer research bodies merge. |
| CRA 2002; 86:6 |
Guidance for bioterrorism treatments. |
| CRA 2002; 87:1 |
NHS - pharmaceutical industry partnership to make UK more competitive. |
| CRA 2002; 87:2 |
Action plan to make the UK a competitive clinical research base - review of
the latest PICTF report. |
| CRA 2002; 88:6 |
Virtual health network is a source of drug information. |
| CRA 2002; 91:7 |
Europe experiences alarming rise in TB. |
| CRA 2002; 91:7 |
EU-Swiss MRA now in force. |
| CRA 2002; 91:8 |
WHO holds high level talks with the European Commission. |
| CRA 2002; 93:4 |
Patients want more direct information: EU set to change rules. |
| CRA 2002; 95:4 |
Guidance on comparability of biotechnology-derived proteins. |
| CRA 2002; 95:6 |
Medicines Control Agency and Medical Devices Agency to merge. |
| CRA 2002; 98:6 |
New joint agency for UK: MHRA. |
| CRA 2002; 99:8 |
New therapeutic area guidance. |
| CRA 2002; 101:3 |
Parliament vote against direct information to patients. |
| |
|
| 2001 |
|
| CRA 2001; 67:6 |
UK tax credits for R&D. |
| CRA 2001; 70:6 |
Price fixing of OTC medicines ends. |
| CRA 2001; 70:6 |
Information about medicines. |
| CRA 2001; 67:6 |
UK tax credits for R&D. |
| CRA 2001; 70:6 |
Price fixing of OTC medicines ends. |
| CRA 2001; 70:6 |
Information about medicines. |
| |
|
| 2000 |
|
| CRA 2000; 40:2 |
Rocky start for the new Dutch medical research law. |
| CRA 2000; 45:3 |
New research regulations for Switzerland. |
| CRA 2000; 51:6 |
Counterfeit pharmaceuticals! |
| CRA 2000; 54:6 |
Donation to kidney patient charity. |
| CRA 2000; 59:6 |
Paediatric trials are to be encouraged in the EU. |
| |
|
| 1999 |
|
| CRA 1999; 34:6 |
New European cancer group. |
| CRA 1999; 38:5 |
Industry falls short of German Medical Association expectations. |
| |
|
| 1998 |
|
| CRA 1998; 6:1 |
New law governing medical research in the Netherlands. |
| CRA 1998; 9:4 |
Summary of the Huriet Law. |