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25.04.2023 (Обновлено: 26.04.2023 16:50)

Main directions for developing regulation of medicines circulation in EAEU discussed at Scientific and Practical Conference "RegLek-2023"

Chinara Mambetalieva, Deputy Director of the EEC Technical Regulation and Accreditation Department, reported on the Eurasian Economic Commission's activities on updating the acts regulating the medicines circulation in the Eurasian Economic Union with due regard to the accumulated law enforcement practice and recent trends in international practice, at the Scientific and Practical Conference "Expertise and Registration of Medicines in the EAEU" — "RegLek — EAEU-2023" held in Moscow.

 

  At the conference plenary session Chinara Mambetalieva noted the last year's release of the second part of Volume I of the EAEU Pharmacopoeia and the extension of the possibility until the end of 2023 to apply for registration simultaneously with site inspections for GMP compliance. The priority direction for development — regulation of the registration procedure — has experienced important changes that simplify the work of applicants: many initiatives of the pharmaceutical business have been taken into account, including the possibility to file parallel applications to several recognizing States and make amendments to the marketing authorization application before submitting to all of the recognizing States declared.

In view of these changes, the applicants' activity is increasing. At the beginning of April, more than 7,000 applications for registration procedures under the EAEU rules were submitted, and more than 1,700 registration certificates were issued.

According to Chinara Mambetalieva, the second development priority for the EAEU common market regulation this year includes developing the EAEU good practice system, including updating good practices and preparing draft rules for conducting GLP inspections, GCP inspections and GVP inspections.

At present, considerable experience has been accumulated in applying the Registration Rules, and proposals for their improvement are actively considered. The work is underway on five draft amendments to improve the regulation of high-tech pharmaceuticals, to optimize the composition of the first module of the marketing authorization application, and to update the procedure for compliance with the EAEU requirements and the procedure for making amendments to the marketing authorization application.

 

Besides, it is planned to adopt acts in H2 of this year aimed at harmonizing the regulation of related issues with the registration process, as well as acts related to good practices.

Furthermore, the plenary session featured reports by representatives of the authorized bodies and organizations of the EAEU countries on ensuring the sustainable development of medicines circulation and pharmacological support, developing control and supervision activities in the field of medicines circulation, the current situation and application of the Union's acts in the Member States.

Employees of the EEC Technical Regulation and Accreditation Department took part in the thematic sections of the conference, informing the attendees about special aspects of new types of registration procedures, the GxP system development and research.

 

For reference

The Scientific and Practical Conference "Regulatory Practice and Registration of Medicines" — "RegLek", held by the Federal State Budgetary Institution "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of Russia, is one of the main annual events attended by the EAEU pharmaceutical market entities, where relevant matters of medicines circulation and law enforcement practices are considered.

The EAEU has adopted Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Pharmacovigilance Practice (GVP), which are common for the Member States.