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Two bodies are tasked with ANSM’s governance: a Management Board, and a Scientific Board.

In addition, since 2019, the Agency’s policy of openness to civil society has resulted in healthcare system users being systematically involved in our consultative bodies of expertise. We are convinced of the need to work alongside patients and healthcare professionals to ensure that our action addresses the challenges that they face on a daily basis.

For this reason, our decisions are based on the opinions of several consultative committees, in which the expertise of representatives of civil society, their perspective, and their vision of the health sector allow objective and informed decision-making.
 

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.
The pharmacopoeia is mandatory for quality control of medicines during their development, manufacture, and marketing in France, Europe, and all countries that have signed the convention relating to its elaboration. It enables the harmonization of quality standards in order to guarantee patient safety. It covers the qualitative and quantitative composition of drugs and the raw materials used in their manufacture as well as the tests to be carried out to control their quality  All manufacturers of medicines and/or substances for pharmaceutical use must apply these quality standards in order to market their products in the signatory countries.

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.
 
Consult public conflict-of-interest statements - DPI Santé website
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.