The Ministry of Health proposes to amend the rules for the expert examination of medicinal products necessary for their registration in line with harmonization with EEU law.

Amendments have been prepared to Order No. 558n of 24.08.2017 regulating the rules for the expert examination of medicines.

The draft order clarifies the procedure and reduces the timeframe for conducting expert examination of medicines, as well as the regulations on interaction between applicants and an expert organization. It is proposed to establish only electronic interaction with the expert organization through the applicant’s personal cabinet. The deadlines for expert responses will be linked to electronic notifications. If additional questions arise or clarifications are needed, the applicant must respond within 90 working days from the date of receipt of the request. If it is necessary to conduct a pharminspection of production, documents on its results or the EAEU GMP certificate shall be provided within 180 days from the date of receipt of the expert’s request.

Specific types of expert examinations are clarified. In particular, the amendments will affect the list of documents to be submitted for expert examination for the recognition of a medicinal product as an orphan drug. In addition, draft characteristics of an unregistered drug, information on the stage of development, reviews of preclinical and clinical trials and, if available, reports on their conduct will need to be sent.

It is proposed to shorten the timeframe for the decision to conduct an expert examination of the quality of pharmaceuticals and an expert examination of the ratio of the expected benefit to the possible risk of using the drug. For example, the period of expert examination will be reduced from 40 to 30 working days, and in case of changes in the registration dossier – from 70 to 40 working days.

The Ministry of Health also proposes to reduce the period of expert examination of the quality of a pharmaceutical substance from 60 to 30 working days. The period of examination of documents for obtaining authorization to conduct QI will be reduced from 30 to 25 working days.

If the draft order of the Ministry of Health is approved, its provisions will become effective on January 1, 2025.

It should be noted that in April 2023 an order of the Ministry of Finance simplified the rules for bringing the registration dossiers of registered pharmaceuticals into compliance with the law of the Eurasian Economic Union.