3. Fulfilling medicines regulation during approval process in the EU
Fulfilling medicines regulation during approval process in the EU
Besides determining the requirements for quality, safety and efficacy, EU regulations and directives also describe administrative and logistical aspects of medicines approval. When a pharmaceutical company wants to have a new medicine approved, they must submit an application for marketing authorisation (Marketing Authorisation Application (MAA)). You can find a brief description of the format to be used for such an application in Lesson 2 under 4.2 - ICH Common Technical Document (CTD).
There are three main procedures to submit an application, involving the EMA and/or the National Competent Authorities (NCA):
Controlled by NCA
Controlled by EMA
Decentralised or Mutual Recognition Procedure (DCP, MRP)
Controlled by NCAs
The EMA plays a very important role, both in medicines regulation and medicines approval. The agency is responsible for running the centralised procedure (CP). The agency hosts a series of committees. The most important for medicines approval, is the Committee for Medicinal Products for Human Use (The committee that is responsible for preparing the Agency's opinions on questions concerning human medicines. Abbreviated as CHMP).
- Submissions for the CP must be sent to the EMA and are processed by the CHMP.
- Following assessment of the dossier, the EMA will send the CHMP opinion to the European Commission.
- The Commission will typically, in the case of a positive opinion, grant a MA. This MA will be valid in all EU member states at the same time. Also, the EEA countries (Norway, Iceland, and Liechtenstein) will accept the product via their own legal action.
The experts performing the assessment of submissions for the EMA come from National Competent Authorities. The EMA does not have their own high-level assessment experts but draws on a European network of more than 4500 experts. In brief, the evaluation of a submission for a new medicine in the centralised procedure proceeds as follows:
- Two expert teams (a rapporteur and co-rapporteur team) assess the dossier to ensure compliance with legislation and guidelines and form an opinion on the scientific acceptability of the results put forward by the applicant.
- CHMP combines the assessments into one report and a list of questions (LOQ).
- The LOQ is sent to the applicant who will answer within 6 months.
- A second assessment is completed by the expert teams.
- The ’opinion’ (positive or negative) is sent to the Commission.
- The Commission will grant a MA – or refuse it.
- If a MA is granted, the company may market the product. In a number of MS the product cannot be marketed until price negotiations are concluded.