All human medicines derived from biotechnology and other high-tech methods must be evaluated by the European Medicines Agency (EMA) via the centralized procedure called single marketing authorization before they can be marketed and made available to patients in the EU.
The evaluation process is carried out by the EMA’s Committee for Medicinal Products for Human Use (CHMP) with input from the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Advanced Therapies (CAT). The evaluation process usually takes up to 210 days, however the processing time may be reduced to 150 days if the medicine is granted accelerated assessment (for medicines considered of major interest for public health).
During the EMA’s evaluation process, the benefit risk balance of the medicine will be thoroughly assessed. The recommendation for marketing authorization will be provided for medicines based on evidence that their benefits outweigh their risks.
For medicines that are intended to treat life-threatening/rare diseases and when there is no alternative treatment available, the EMA may recommend marketing authorization based on less complete or limited evidence on the medicine, provided that additional data are submitted at a later stage. As for all marketing authorizations, the positive balance between the benefits and risks still must be demonstrated.
Under EU legislation, the EMA does not have the authority to grant marketing authorization in the different EU countries. At the end of the evaluation process, the EMA provides a scientific opinion on whether or not the medicine should be authorized. The European Commission then makes the final legally binding decision based on the EMA’s recommendation within 67 days of receipt.
Once the centralized marketing authorization is granted by the European Commission, the pharmaceutical company will be allowed to market the medicinal products and make them available to patients and HCPs in all EU countries. However, companies should be aware of each EU country’s specific local requirements as decisions about pricing and reimbursement take place at the national and regional levels.
Above all, France, Germany, and Italy have very specific requirements for new medicinal product launches. Thus, it is important to know the requirements for each EU country and to follow the adequate steps during pre- and post-approval phases.
For instance, to launch centrally authorized drugs (CAP) in France, companies are required to follow the key steps below:
- Blue-box information request from the ANSM (Agence nationale de sécurité du médicament et des produits de santé)
- Reimbursement dossier submission to HAS (Haute autorité de santé) and CEPS (Comité économique des produits de santé)
- Patient leaflet conversion into braille.
Contact our experts today to learn more about the EMA’s Single Marketing Authorization process and country-specific requirements to successfully and efficiently launch your medicines in the EU.