Terms of the Sputnik V vaccine approval procedure in the European Union announced

BRUSSELS, February 26 – RIA Novosti. The European Medicines Agency EMA explained to RIA Novosti that the procedure for approving new vaccines and drugs against coronavirus has been seriously accelerated since the beginning of the pandemic, but it still takes several months, since it is necessary to verify the effectiveness and safety of emerging drugs.

Earlier it was reported that the developer of the Russian vaccine against coronavirus Sputnik V is negotiating with the European drug regulator EMA to register the vaccine on the EU market (obtain a registration certificate).

The issue of accelerating the registration of new vaccines was discussed on Friday at a special videoconference of the heads of state and government of the European Union. Following the talks, European leaders decided that it was necessary to “urgently speed up the authorization, production and distribution of vaccines.”

At present, even an accelerated procedure for authorizing medicinal products takes more than one month and is associated with detailed studies of both the effectiveness and possible negative side effects of the drug. “The EU drug research and approval processes are reliable procedures and are based on high standards of quality, efficacy and safety,” said an EMA spokesman.

The standard duration of the procedure for the assessment of medicines by the EU regulator is about 210 working days. In this case, two breaks are allowed for a period of one to six months, during which the EMA directs questions or requests for additional information to the developer. As a result, the authorization of a new drug on the EU market may take a year. Thanks to the accelerated procedure, the study of drugs against coronavirus has been reduced to 150 working days. But the speed of the EMA's decision-making directly depends on the data provided by the developer, as well as on how quickly it will respond to additional questions from the regulator.

The European regulator can also use a special rolling review process to speed up the assessment of promising drugs. This allows the EMA to evaluate product data as it becomes available during the development process and further shorten the application review period.

For example, on February 15, Johnson & Johnson filed an official application for authorization of its coronavirus vaccine in the EU. According to the calculations of the European regulator, this application may be approved as early as mid-March. At the same time, EMA reported that it had been conducting a gradual examination of the J&J drug since December 1 of last year, and European experts have been monitoring the stages of vaccine development all this time. In addition, a vaccine manufacturer may contact a European regulator for so-called “scientific advice” even before filing a formal application to enter the pan-European market.

“During the development of a drug, the developer may request from the EMA guidance on the most acceptable EU methods and form for the presentation of the drug, its effectiveness and safety,” – says the EMA documents. Thus, the European regulator is trying to shorten the time for filing and considering the application as much as possible, indicating to the applicant what data and in what form is better to collect and submit for the EMA assessment.

“At the same time, scientific advice is not a preliminary assessment of the benefits and risks of the drug, and does not guarantee that the drug will receive marketing authorization,” the EMA said.

At the beginning of February, EMA reported that the developer of the Russian vaccine Sputnik V had already successfully passed a scientific consultation and could prepare an application for obtaining permission to market the drug in the EU. To date, EMA has not confirmed that it has started a gradual review process for Sputnik V or that the developer has applied for registration.

When applying for a marketing authorization, the developer submits to the EMA all the information gathered during the development, testing and production of the drug. The agency then evaluates this information and determines if the drug is safe and can be recommended for use in the EU. The main principle in evaluating an EMA drug is to balance its benefits and risks. The agency conducts consultations with the developer, in which the agency's specialists in various fields take part. This should ensure the quality of the application, the compliance of the data provided in it with European requirements.

The EMA notes that it carefully selects experts to participate in the various stages of drug evaluation to ensure their impartiality. The European Medicines Agency ensures that scientific experts who evaluate drugs do not have any financial or other interests that might affect their impartiality.

An expert committee (EMA Scientific Committee for Human Medicines CHMP) participates in the assessment. He examines all submitted applications and then votes on the issue of providing a marketing authorization. The committee includes representatives of national regulators from all EU member states, as well as Iceland and Norway. Each committee member has his own team of assistants. The CHMP can also include up to five European experts in specific specific areas (such as statistics, quality control) appointed by the European Commission. For each new drug proposal, the EMA CHMP committee will appoint a rapporteur and a co-rapporteur (or just a rapporteur) to guide the product evaluation process. They conduct a scientific assessment of the data submitted in the application independently of each other, prepare their reports and formulate questions for the developer. Rapporteurs may also recommend an inspection of the manufacturing facility. The inspection may be attended by representatives of European national drug agencies.

Based on the results of the multi-stage review of the application, the CHMP committee at its plenary meeting will vote to approve or reject the developer's application for obtaining a marketing authorization. At the same time, the EMA emphasizes that in almost 90% of cases it is possible to reach a unanimous decision of the committee.

In a pandemic, the EMA may recommend the issuance of a temporary or conditional marketing authorization. Such a permit is intended to be issued in an emergency when there is a threat to public health at EU level.

If the application is supported, then the EMA recommends it to the European Commission, which makes the final decision on the introduction of a particular drug to the EU market. Further decisions, for example, on the price of the drug, are made during negotiations with the manufacturer at the national level, if we are not talking about centralized procurement of the drug by the European Commission.

The EMA also notes that after the issuance of a registration certificate, monitoring of the use of the drug continues, an assessment of its side effects is carried out, corrections and additions can be made to the certificate or to information about the drug and its use.

Currently, three vaccines are authorized on the EU market: Pfizer / BioNTech (purchase up to 600 million doses), Moderna (two contracts up to 460 million doses) and AstraZeneca (up to 400 million doses). In addition, the EC entered into contracts for the supply of vaccines to the EU with Johnson & Johnson, Sanofi-GSK, CureVac. Until now, Sanofi-GSK and CureVac have not yet submitted applications to authorize their drugs on the EU market, J&J applied for authorization on February 16. CureVac, in turn, made a request for a rolling review on February 12. In total, the EU countries thanks to the contracts of the European Commission will be able to get access to more than 2.3 billion doses of anti-coronavirus vaccines. The EU expects that by mid-September, about 70% of Europeans will be vaccinated.

In recent weeks, the EU has faced a number of challenges in the supply of alliance-approved vaccines from Pfizer / BioNTech and AstraZeneca. Delays in deliveries could derail Brussels' ambitious vaccination plans.

Author: wedocount

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