EMEA: Experiences Of The First Year

The approval of Ares Serono's infertility treatment Gonal-F (follitropin alpha), as the first by the European Medicines Evalution Agency under the centralized procedure (Marketletter October 30, 1995), was an occasion for "great corporate emotion," and led to the company's decision to use manufacturing sites within the European Union in order to be able to make use of this procedure, according to Paola Ricci, senior executive vice president, R&D and regulatory affairs at Ares-Serono Group.

Discussing Ares-Serono's experience with the new procedure at the Third Annual Conference of Medicines Agencies in London last month (Marketletter April 29), Dr Ricci said that the switch from the concertation to the centralized procedure did not affect the company's relationship with the rapporteur. But, she added, the post-Committee for Proprietary Medicinal Products' opinion procedure (up to the final granting of the license) was not as transparent as it might have been. Companies which have not gone through the full procedure should take this into account, she said, and called for clarification and advice for sponsors.

Foreign Testing, Inspections EMEA executive director Fernand Sauer replied that Gonal-F represents a learning process as the first approval of its kind, in which questions had been raised which should not appear again, and that the problems with foreign testing and joint inspections experienced by Ares-Serono rest with the USA. (The EU is awaiting a US Food and Drug Administration proposal on mutual recognition of inspections and manufacturer batch releases, and the EU Ambassador to the USA, Hugo Paemer, has told the Pharmaceutical Research & Manufacturers of America that he believes the problem "centers on the reluctance of some parts of the US administration" - Ed).