Christmas Came Early this Year! At the TOPRA European Medicines Agency Review of Medicines Legislation…

London 3-4 December – a proposal to restructure the European Medicines Agency (EMEA) was announced for the first time this week at the third annual EMEA Legislation Update, hosted jointly by The Organisation for Professionals in Regulatory Affairs (TOPRA) and the EMEA.

More than 240 delegates from across Europe attended the meeting – an excellent forum for candour between key regulatory personnel from pan-European national agencies and industry – on EMEA coordinated applications issues.

Irene Sacristan Sanchez from the European Commission officials promised a number of early “Christmas Presents” in the form of the soon to be released “Pharma Package” which includes three legal proposals:
1) Safety of the supply chain – a proposal to make counterfeit medicines less likely
2) Information to patients – to improve pharma's ability to communicate with patients
3) Pharmacovigilance – to provide stronger public health protection through clarification of the rules.

Irene also promised that the Variations Regulation would be published in December and be effective in 2009.

One of the major RA issues at the moment is transparency and Vincenzo Salvatore, Head of Legal Sector, EMEA, announced the EMEA Transparency Project. This will provide policy agreeing a common approach to proactive disclosure of information that does not undermine competition, protects the independence of assessment, ensures a consistent approach throughout Europe, and discloses information that may be considered in public interest. In line with recommendations of the Heads of Medicines Agencies there are plans to disclose agendas and minutes of EMEA meetings and proactive disclosure of ongoing procedures.

The Paediatric session provided a useful exchange of views and concerns on the implementation of paediatric legislation in the development of paediatric products. There was also a heavy steer on early dialogue and including all possible indications in the PIP application rather than waiting and adding indications later. Agnès Saint Raymond, Head of Orphan drugs, scientific advice and Paediatric medicines, EMEA urged delegates to “take the opportunity for early dialogue. This is team work. We have a lot of work and working together it can be done.”

In his first public appearance as the new Head of Sector, Pharmacovigilance and Risk Management at the EMEA, Dr Peter Arlett gave an update on EMEA activities on pharmacovigilance and its priorities for 2009 stating that "networks and partnerships are key". In this session Dr June Raine, Director VRMM, MHRA and chair CHMP Pharmacovigilance working party stressed the importance of a more balanced view on risk management which includes the positive benefits of medicines.

From the EMEA’s point of view Patrick Le Courtois, Head of Unit, Pre-authorisation Evaluation of medicines for human use, EMEA, commented “This third annual meeting provided a good balance of constructive discussion and provocative questions to the EMEA. The opportunity is appreciated by the EMEA and we are happy to take onboard comments.”

In closing the meeting Alan Hunter, President, TOPRA, thanked all participants in this collaborative meeting which he said "had simply been the biggest and best yet." He looked forward to the February 2009 meeting with the Commission explaining the legal proposals in the “Pharma Package” and the next meeting with the EMEA which would be held in Dec 2009.

For information on the most up to date training and conference programme for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector a full list of TOPRA events can be found at www.topra.org/events.