Dubininskaya str. 57, bld.1, 115054, Moscow, Russia
info@regapharm.com

+7(499)517-95-23

Main  >  News  >  EEC excludes duplication of GMP inspections of drug manufacturers

EEC excludes duplication of GMP inspections of drug manufacturers

On December 25, public discussions begin on the draft decision of the EEC Council “On Amending the Decision of the Council of the Eurasian Economic Commission of November 3, 2016 No. 93”, concerning the issue of recognition of the results of inspections of drug production in the period 2020 - 2025. The document is published on the docs.eaeunion.org portal. The public discussion of the project will last until January 24, 2020.

Recall that in the framework of the transition to a single market, the EAEU legislation provides for 3 periods for drug manufacturers, following which the drugs registered in accordance with the laws of the Member States should be brought into line with the requirements of international treaties and acts constituting the EAEU law, and from January 1, 2026, only Union rules will apply to all industries. Moreover, until December 31, 2020, the registration of a medicinal product may be carried out at the option of the applicant, either in accordance with the Rules of the EAEU or in accordance with the legislation of a Member State. Until that date, the applicant, instead of a certificate issued by an authorized body of a Member State, is entitled to submit a certificate (or other similar document) issued by an authorized body of Member States in accordance with the laws of the Member State. Simultaneously with this Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 93 “On the Recognition of the Results of Inspection of the Production of Medicines” it was established that until December 31, 2020, the authorized bodies of the Member States during state registration (re-registration, confirmation of registration, amendments) in the registration dossier of a medicinal product) of medicinal products, in accordance with the legislation of a Member State, documents issued by the authorities of the Member States confirming the conformity of the production of medicines produced only in the Member States with the requirements of the good manufacturing practices of the EAEU or the requirements of the good manufacturing practices of the EAEU Member States.

As explained in the informational and analytical reference to the draft decision, the document and the mechanisms presented therein are aimed at solving the problem of resolving the possibility of providing until December 31, 2025 during the state re-registration, confirmation of registration, amendments to the registration dossier of medicines in accordance with state law– EAEU member, documents issued by authorized bodies of the Member States confirming the conformity of drug production with requirements of the good manufacturing practice of the Union, in order to eliminate the need for duplication of repeated inspections of drug manufacturers by authorized bodies of Member States. This fact will also help to reduce the time required for regulatory procedures.

According to the draft decision posted on the EEC portal,

Until December 31, 2020, the authorized bodies of the EAEU member states when performing state registration (re-registration, confirmation of registration, variations to the registration dossier of a medicinal product) of medicines in accordance with national law mutually recognize documents issued by authorized bodies of the Member States of the Union, confirming compliance of the production of medicines with the requirements of good manufacturing practices of the EAEU or for medicines produced in EAEC member states, the requirements of good manufacturing practices of the Member States EAEC

January 1, 2021 - December 31, 2025 the authorized bodies of the EAEU member states, when re-registering, confirming registration, amending the registration dossier of a medicinal product in accordance with national law, mutually recognize documents issued by the authorized bodies of the EAEU member states confirming the conformity of production medicines to the requirements of the EAEU's Good Manufacturing Practice or for medicines manufactured in the member states of the Union, the requirements of good manufacturing practices of the Member States EAEC.

The developers of the project indicate that among the previously presented alternative solutions, the termination of Council Decision No. 93 was considered upon reaching the specified period for the recognition of certificates. However, this alternative could lead to the resumption of the practice of conducting repeated inspections by the authorized bodies of the Member States of drug manufacturers and, accordingly, the need to conduct inspections of each production site at least 5 times (by each of the pharmaceutical inspectorates of the EAEU Member States). This approach posed a significant burden on the pharmaceutical inspectorates of the EAEU Member States, conducting repeated inspections of drug manufacturers by the authorized bodies of the Member States, increasing the costs of regulatory authorities and manufacturers, increasing the time for registration of drugs in the Member States, and had risks of defective drugs.

Make request

Your name

Your phone

Your email (required)

Choose the topic of your message

Your message