A procedure for immunobiological drugs testing has been developed in the Russian Federation

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Roszdravnadzor presented a draft regulating the procedure for evaluating the scope of quality tests of immunobiological drugs by the competent commission. It suggests that the scope of testing be reduced for new drugs or those imported into Russia for the first time, following the successful control of at least 15 of their series. The audit should cover all indicators, without exception, established by both regulatory documents and registration requirements of the Eurasian Economic Union (EAEU).

According to the new procedure, tests of immunobiological drugs will be conducted by accredited institutions of the Ministry of Health and Roszdravnadzor, and their assessment will be carried out by the commission of Roszdravnadzor in charge of the matter. Such an assessment is provided only for registered drugs that are already in circulation in Russia and have been included into the information system of the Service.

The Commission determines the scope of tests to check the quality of a particular immunobiological product, taking into account its form and dosage, based on an annual analysis of quality data. Federal agencies must submit these data to it by March 1.

In addition, it will take into account information from manufacturers, importers and other market participants, including the results of state supervision in drug circulation, information on drug recalls by manufacturers, the results of inspections of compliance with good manufacturing practices, identified violations of drug quality requirements or manufacturer’s documentation, as well as data on the results of previous tests.

Based on these data, the executive secretary of the commission draws up a list of drugs that will be tested. The list has to be prepared within 7 working days. Every year, no later than April 1 of the year following the reporting period, the commission holds a meeting to decide on the scope of quality tests and the frequency of their conduct for each immunobiological drug.

The scope of tests can be reduced only when test statistics are stable, there are no quality violations or critical production failures, and there are no reports of serious side effects or health risks.

Roszdravnadzor will post the commission’s decision on its official website within 5 working days from the date of the decision. The commission is going to hold scheduled meetings at least once a year. Unscheduled meetings may be held as necessary.

The new order should replace the Roszdravnadzor order, which has been in force since 2019. In addition, Roszdravnadzor has published a draft order on the establishment of the commission that would be in charge of the task. According to the explanatory note to the document, the implementation of the Roszdravnadzor project will not require the allocation of financial resources from the federal budget. If the documents are approved, both regulations will be valid until June 10, 2031.