Revue Prescrire, article en une, Medicines in Europe Forum leaflets (5)
Prescrire     Accueil  
Article en Une - Archive
Medicines in Europe Forum leaflets
Why can the centralised procedure for marketing authorisations be extended without negative consequence for national medicines agencies?
Leaflet N°5
27 August 2002

Medicines in Europe Forum is for a rigorous and transparent centralised evaluation of all medicines released on the EU market, together with improved surveillance of drug utilisation at the member state level. Much work needs to be done within the European agency as well as in national agencies if that parallel objective is to be achieved.

That is why Medicines in Europe Forum has put down a series of amendments on this subject to the proposed European Directive and Regulation for medicines.


List of leaflets

Previous leaflet

Next leaflet

Medicines in Europe Forum
Click here
The European granting of marketing authorisations by a sole centralised procedure would allow for a better harmonisation of evaluation, greater transparency of decisions (conforming to the EU Regulation 1049/2001) and therefore greater confidence of the public in medicines thus licensed by the European Agency for the Evaluation of Medicines (EMEA). A unique and transparent European agency, provided it is well staffed and efficient, would challenge the American FDA and strengthen the image of medicines approved in Europe.

True, the non-harmonised and opaque procedure so called "by mutual recognition" cannot be removed rapidly, but a progressive removal over 5 years can be planned. It will necessitate an increase in public funds for the European agency but will not put the small and medium pharmaceutical companies in danger nor the national medicines agencies.

Indeed, all marketing applications do not require the same evaluation work. Applications for generics do not require new evaluation on humans, but at the most bio-equivalence studies. Applications for herbal medicines do not involve further clinical evaluation if the plant features on a list of plants authorised for traditional use and offering safety guarantees. The same goes for homeopathic medicines. And the requirements are also simplified for new presentations/formulations of medicines existing already.

As a result, drug companies could pay smaller fees for a centralised authorisation depending on regulatory work, so as not to cause prejudice to small and medium size companies.

The national agencies currently involved in the mutual recognition procedure would keep on working for exclusively national licensing. They could devote more of their means to the setting up of active pharmacovigilance, to a more systematic monitoring of numerous infractions to regulations on pharmaceutical advertising, to more frequent inspections of pharmaceutical facilities and supervision of clinical trials underway in the country. Finally, a number of executives could be offered positions with the European Agency.

If the Bayer product cerivastatin had been granted marketing approval by a truly transparent centralised procedure done at the European agency, and if national agencies had been in a position to better monitor emerging side effects and control strictly the media hype that led rapidly to a massive uptake of this poorly known statin, then a serious crisis might have been avoided.