Register of permits issued for clinical studies of drugs in the EAEU

2021: Creating a Registry

In September 2021, it became known about the approval in the EAEU of the creation of a single register of clinical drug research. It will include, among other data, brief information on the results of drug testing.

The project was approved by the Eurasian Economic Commission (EEC). The register of clinical studies of drugs at the level of the Eurasian Economic Union should earn by the spring of 2023.

EAEU approved the creation of a unified register of clinical drug research

Unified rules for the registration of medicines were earned for Russia from January 1, 2021, for Armenia, Belarus, Kazakhstan  and Kyrgyzstan - from July 1, 2021. 

Earlier, the Board of the Eurasian Economic Commission approved the EAEU Pharmacopoeia, which became the basis of a unified approach to assessing the quality of medicines for five allied countries. The document began to operate on March 1, 2021. Manufacturers of drugs previously registered in the common market of the Union were given a 5-year term - until January 1, 2026 - to bring their regulatory documents on the quality of medicines in line with the Pharmacopoeia of the Union.

Until December 31, 2025, procedures for amending and confirming registration, as well as extending the validity of the registration certificate for urgent registration certificates in accordance with the legislation of the EAEU states, will be available for medicines registered in the countries of the Union.

In the general market of medicines of the EAEU, medicines can be used, the quality, effectiveness and safety of which is evaluated in accordance with the requirements of the Union, taking into account the best world practices. This is ensured by the mandatory observance of good practices (GxP), confirmed by the documents of the registration file prepared in the CTD format , and the results of the laboratory assessment of the quality of drug samples.^[1]

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