TOPRA and EMEA held a joint meeting on 7th and 8th December to discuss progress of the New Medicines Legislation one year after its implementation. The event was hailed a success with a variety of sessions providing the 150 attendees with information and insight on the New Medicines Legislation as well the opportunity to discuss issues with key officials from the EMEA, CHMP and competent authorities.
One session explored the new elements of the Centralised Procedure—introduced in November 2005. The presentation contained extremely useful details around the implied access to the Centralised Procedure as well as a lively discussion of the EMEA ‘stop-clock’ policy.
On the issue of pharmacovigilance there was a one year review of risk management plans. Stella Blackburn and Xavier Kurz of the EMEA provided helpful comment with regard to the Centralised Procedure experience of risk management plans. June Raine, Chair of CHMP Pharmacovigilance Working Party and Director of Vigilance Risk Management of Medicines, MHRA UK, also highlighted support of Member State Agencies for risk management plans throughout the European Union.
On the issue of benefit/risk reassessment emphasis was placed upon the value of post-authorisation monitoring of medicinal products throughout the product life cycle. The re-evaluation of the benefit/risk authority, at its 5 year review stage, and its impact on sponsors were fully described, with warning given that companies could lose their marketing authorisations which could alter promotional activities.
TOPRA Board Member Brenton James said, ‘The Centralised Procedure is a quintessential element of the New Medicines Legislation. This was an important session to understand how it is working in practice and to allow the EMEA to communicate nuances of procedure that they have learned from one year of experience.’
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