Experts from the European Medicines Agency will visit Russia to inspect the Sputnik V vaccine, DW reports.
The European regulator does not disclose the details of the inspection, the press service of the department notifies that it does not comment on the intermediate stages of drug testing. The official version, which is reported by the director of the pan-European structure, Emer Cook, sounds like this: “inspection of production and clinical facilities in Russia.” The agency explains:
The EMA is legally obliged to ensure that manufacturers of medical products seeking admission to the EU market comply with Good manufacturing practice (GMP).
That is, we are talking about the standards for the production of medicines. Compliance with GMP makes it possible to make sure of the high quality of the drug, its compliance with the intended purpose and the requirements for its registration in the European Union. The second task of the inspection is to validate vaccine trials against clinical practice (GCP), the EMA emphasizes:
Meeting these standards ensures that the rights, safety and well-being of trial participants are protected, and that clinical trial data can be trusted.
The conclusions of the European regulator will be published only after consideration of the application for registration of the Russian vaccine in the EU. The start date of the inspection is being specified. The head of the Russian Ministry of Health, Mikhail Murashko, announced that the experts would arrive on April 10. And The Financial Times reported on April 7 that the inspection would begin next week.
Such a check cannot be considered a consequence of a bias towards the Russian vaccine. The EMA calls it the “normal step” required to register a drug in the European Union. Experts assure that a similar test was carried out for all EU-registered COVID-19 vaccines: Moderna, BioNTech / Pfizer, AstraZeneca and Johnson & Johnson. This fact is confirmed in the EMA reports.
Within the EU, national regulators oversee the implementation of vaccine production standards, with the EMA acting as the coordinator. Outside the EU, an inspection is not carried out only when it has been carried out over the last 2-3 years, says the official representative of the European regulator.
The rate of vaccination in the European Union cannot be called effective – the EU lags behind many countries and regions of the world. It is no coincidence that the Minister of Health of the Federal Republic of Germany Jens Spahn recently announced negotiations Berlin and Moscow on the purchase of the Russian vaccine, but only after its approval by the EMA.
However, it is still unclear how many doses of Sputnik V could be supplied by Russia – as long as it does not have the production capacity for large supplies to the EU. This is confirmed by Russian President Vladimir Putin, in a conversation with Armenian Prime Minister Pashinyan, stating that the volume of production of the drug “is comparable to the demand within the country.”