Pharma Package Discussed at the joint TOPRA and European Medicines Agency Annual Review of Medicines Legislation

London 3-4 December – a “Pharma Package” that identifies and addresses the challenges to provide safe, innovative and accessible medicines was discussed at the third annual 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 agencies and industry across Europe.

At the meeting, Irene Sacristan Sanchez from the European Commission discussed the content 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 – due to an increased demand for information and an increased use of the Internet by patients, this proposal will improve pharma's ability to communicate with patients
3) Pharmacovigilance – a legal proposal 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.

Alan Hunter, President, TOPRA, commented on the session “It will be interesting to see how the proposals evolve and TOPRA will be at the forefront of debate on these issues at their meeting planned for February 2009 in Brussels with the participation of the Commission”

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