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[European drug policy]
1Unité Produits pharmaceutiques, III/C/3, Commission des Communautés européennes, Bruxelles.
Bulletin Et Memoires De L'Academie Royale De Medecine De Belgique
|January 1, 1993
Summary
European pharmaceutical legislation harmonization continues with new marketing authorization procedures for human and veterinary medicines, alongside improved pharmacovigilance coordination.
Area of Science:
- Pharmaceutical Regulation
- Drug Evaluation
- European Union Policy
Context:
- European pharmaceutical legislation harmonization was largely completed by 1992.
- Harmonization of marketing authorizations remained incomplete, necessitating further regulatory development.
- The establishment of a European medicines evaluation agency was identified as a key requirement.
Purpose:
- To outline the upcoming changes in pharmaceutical marketing authorization procedures within the European Community.
- To introduce the dual-procedure system for human and veterinary medicines effective January 1995.
- To emphasize the need for enhanced coordination in pharmacovigilance.
Summary:
- Two complementary marketing authorization procedures will be implemented for human and veterinary medicines starting January 1995.
- A decentralized procedure will cover most products, while a centralized procedure will be reserved for innovative medicines.
- Improved coordination of adverse drug reaction assessment (pharmacovigilance) is also planned.
Impact:
- This regulatory shift aims to streamline drug approval processes across the European Community.
- The new procedures are expected to facilitate market access for pharmaceutical products.
- Enhanced pharmacovigilance coordination will improve the monitoring of drug safety post-authorization.