New Euro Drug MA System: Second Audit

The second audit of the new European marketing authorization system, held in late October at the European Agency for the Evaluation of Medicinal Products in London, was chaired by European Commissioner for industrial affairs, information and telecommunication technologies Martin Bangemann. He noted that the purpose of the audit was to examine the progress achieved in the functioning of both the centralized and mutual recognition procedures.

Jean-Michel Alexandre, chairman of the Committee for Proprietary Medicinal Products, said experience with the centralized procedure had been a real success. The number of applications was encouraging, and all CPMP opinions so far had been positive and adopted by consensus, showing a willingness by members and national experts to work together. Also, the number of voluntary applications showed that the procedure was a success. However, there are two areas of difficulty:

- streamlining decision-taking: this is being addressed. A Commission document showed that time required had been reduced and that more progress was possible only if the Standing Committee procedure was shortened or other changes introduced to Council Regulation (EEC) No 2309/93. Other improvements being studied included a special delegation of power at the Commission for urgent cases; and