The European Medicines Agency is based in Amsterdam. Its scientific committees assess the dossiers of new medicines and issue an opinion; formal authorisation is then granted by the European Commission and is valid in every EU country. Many biotechnological medicines, including new-generation peptides, must go through this centralised procedure.
Besides authorising, the EMA coordinates European pharmacovigilance and publishes assessment reports for each medicine, a very detailed source on its efficacy and safety.
That is why, when describing a compound's status, its situation with the FDA (United States), the EMA (European Union) and the local authority, which in Mexico is COFEPRIS, is usually given. The three may not agree.
A compound being approved by one agency does not mean it is approved in other countries. Each authority assesses and decides separately.
Related terms
Definition for educational and scientific purposes. It is not medical advice or a recommendation for use. NeoPeptidos products are sold labelled for research use only (RUO).