EMEA publishes final guideline to cut risk for early clinical trials.(International)

The European Medicines Agency (EMEA) July 26 published the final guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products.

Adopted by the Committee for Medicinal Products for Human Use (CHMP) on July 19, the guideline is intended to assist sponsors in the transition from non-clinical to early clinical development.

It identifies factors influencing risk for new investigational medicinal products and considers quality aspects, non-clinical and clinical testing strategies, and designs for first-in-human clinical trials. Strategies for mitigating and managing risk are given, including the calculation of the initial dose to be used in humans, the subsequent escalation, and the conduct of the clinical trial

Also in July, the EMEA and Heads of Medicines Agencies (HMA) reviewed the status of implementation of the European Risk Management Strategy (ERMS) during their meeting in Lisbon on July 10. They expressed their satisfaction with the progress made to date and had a first discussion on the priority areas for the next two years.

Acknowledging that drug regulation cannot protect the public from every risk, the ERMS aims to provide for a more coherent approach to the detection, assessment, minimization and communication of risks of medicines in Europe through a more proactive approach to safety monitoring of medicines throughout their life cycle.

Achievements made between 2005 and 2007 described in the "Public Status Report on the Implementation of the European Risk Management Strategy" include:

* Implementing the legal tools for monitoring the safety of medicines and for regulatory actions provided for by revised EU pharmaceutical legislation, with particular emphasis on the systematic implementation of risk management plans;

* Strengthening the spontaneous reporting scheme through further improvements to implementation of electronic reporting of adverse drug reactions to the EudraVigilance database;

* Launching the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) project to strengthen the monitoring of medicinal products by facilitating the conduct of multi-center post-authorization safety studies;

* Contributing, in collaboration with the European Commission, to the conduct of research in the field of pharmacovigilance and safety of medicines in the context of the Health Theme of the 7th Framework Program;

* Strengthening the organization and the operation of the EU Pharmacovigilance System. Building on the

achievements to date, the EMEA and HMA are in the process of finalizing a work program on activities to be undertaken over the next two years to further implement the ERMS. A number of environmental changes will impact on this work program, such as the European Commission's "Strategy to Better Protect Public Health by Strengthening and Rationalizing EU Pharmacovigilance."

Two main areas will be covered by the ERMS during the next two years: further improving the operation of the EU Pharmacovigilance System and strengthening the science-that underpins the safety monitoring of medicines for human use.

This work program should be published following the November 2007 HMA meeting.

The "Public Status Report on the Implementation of the European Risk Management Strategy" is available on the EMEA website at: http://www.emea.europa.eu/pdfs/human/phv/16895407en.pdf

By Rebecca Mashaw Associate Editor

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