The European Medicines Agency (EMA) spoke about the procedure for testing vaccines, RIA Novosti reported.
“We cannot disclose information about a specific audit, as this may interfere with the achievement of its objectives. However, we can explain the general steps, ”the agency said.
It is noted that the facilities of companies inside and outside the European Union (EU) that are involved in the development, production and distribution of drugs intended for the European market are regularly checked by the EU authorities to ensure their compliance with applicable standards.
During the audit, experts certify the reliability and completeness of the data that confirm the vaccine approval in the EU, as well as their quality, safety and efficacy after entering the market.
The EMA added that inspections are carried out both in relation to medicinal products already approved in the European Union, and in relation to funds that are currently being evaluated to obtain such a permit.
Earlier it was reported that the European Medicines Agency (EMA) in April will send an inspection to Russia to check “Sputnik V”. The check will touch upon issues related to clinical trials and production of the Russian drug.
