HMA issues Strategy Paper on European Medicines Regulatory Network

The European Heads of Medicines Agencies (HMA), a network of regulatory agencies for human and veterinary medicines of the European Economic Area, has published its strategy paper on the European Medicines Regulatory Network, which was primarily adopted at its November 2005 meeting as a basis for discussions with stakeholders.

This Strategy Paper represents a summary of the views of six drafting groups, each chaired by a head of agency, which dealt with the following themes: communication and information; scientific resources; scientific assessment process; new products and referrals; pharmacovigilance; inspection, laboratory control and enforcement; and information technology systems.

The Paper complements the existing European Medicines Agency (EMEA) Road Map (Marketletters passim) in a number of ways. It is building on the same need to ensure the quality and robustness of assessment, inspection and regulatory action in the system but emphasis is placed on the Mutual Recognition (MRP) and Decentalized Procedure (DCP). It also raises similar issues, for example, the availability of high-quality staff and the need to interact with a number of internal and external stakeholders.