GMP certificate issued by EAEU is prerequisite for drug registration

| By | Drug Registration, EAEU, EEC, GMP Inspectorate

The inspectorates of Russia, Belarus, and Armenia are ready to conduct inspections in accordance with EAEU requirements.

This was announced by Dmitry Rozhdestvensky, the Head of the Division for Creation of Common Markets of Medicines and Medical Products at Technical Regulation and Accreditation Department of Eurasian Economic Commission (EEC).

He reminded that a GMP certificate issued by Eurasian Economic Union is a prerequisite established by the procedure for submitting the dossier to register a drug in EAEU.

Asked about when the drug registration process would really start within EAEU, Dmitry Rozhdestvensky said that, at the commission level, the entire set of issues had been resolved, but some questions remained at the level of member states. By no means all member states of EAEU are ready to connect to the unified information system. However, without it, the registration of medicines under a decentralized procedure is impossible.

GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.