French Pharmacopoeia Committees
All members of our advisory bodies are subject to the ANSM's ethical rules. The composition of these committees, the agendas and meeting minutes are published on the ANSM's website. .
The French Pharmacopoeia Committees draft the texts of the French Pharmacopoeia and participate in the drafting and revision of monographs and texts of the European Pharmacopoeia relating to :
- Starting materials;
- Pharmaceutical preparations.
For pharmaceutical preparations, in addition to the European Pediatric Formulary (Paedform), the European Drug Shortage Formulary (EDSform), created on the initiative of the ANSM, is a European collection of monographs on pharmaceutical preparations.
The members of the French pharmacopoeia committees are appointed by the ANSM's Director General for a four-year term, renewable once.
Like all committees at the ANSM, and to comply with the imperative of independent expertise, members complete a Public Declaration of Interests (DPI). This declaration outlines any potential conflicts of interest, enabling the necessary measures to be taken to step aside members from the examination of specific cases where conflicts may arise.
List of French Pharmacopoeia Committees
The Pharmacopoeia, the reference for medicinal products
- The Pharmacopoeia is an official regulatory publication that defines the purity criteria for starting materials or preparations used in the manufacture of medicinal products (for human and veterinary use), and even their containers, as well as the analysis methods to be used to ensure their control.
- It is a reference tool for healthcare professionals : users of pharmaceutical starting materials, quality control laboratories, drug registration departments and retail pharmacies.
- The latest edition of the French Pharmacopoeia (which came into force in July 2012) is accessible, free of charge, online: French Pharmacopoeia, 11th edition.
- The currently applicable European Pharmacopoeia is the 10th edition. In France, application of the French and European Pharmacopoeias is compulsory.