3. Stakeholders in the development of medicines legislation in the EU

Stakeholders in the development of medicines legislation in the EU

For high-level legislation (regulations and directives) the European Commission is the key actor in the EU. The work on elaboration of such legislative proposals into agreed legislation is a joint effort between the European Commission (proposing the text) and negotiations with the Council, and Council working groups (for medicines: the Health Ministers), and finally the European Parliament. The individual member states may contribute via the Council working groups. Each member state participates; the concrete influence of a given member state can be substantial and depends on efforts and negotiation strategies rather than the size of the country.

At the guidelines level the key institution is the European Medicines Agency (EMA), based in Amsterdam.

Of the many committees and working parties of the EMA, the Committee for Medicinal Products for Human Use (CHMP) is responsible for evaluating applications for MAs for new medicines via the Centralised Procedure (CP). The CHMP is also the body responsible for adopting new guidelines. The CHMP has a number of working parties. Members of the working parties are experts made available by the regulatory authorities in EU member states to elaborate (develop) guidelines. The list of experts is publicly available on the EMA website