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Seminar “Transition to the EAEU GMP rules for registration of drugs”

Within a month, FBU GILS and NP and PHARMSTRATEGIA, as part of a joint program to promote the implementation of best practices in the Russian pharmaceutical industry, will continue their ongoing education program. So, on January 23-24, an open expert consultation seminar will be held on the topic “Transition to the EAEU GMP rules when registering drugs. Regulatory framework and regulatory expectations. Transitional Activities. ”

In the near future, starting in 2021, the national drug registration procedure will cease to exist.

Until 2026, all drugs registered under the national procedure must be brought to the uniform requirements of the EAEU.

In terms of its scale, the transformation of requirements and approaches to the registration of medicines and, in general, to the regulation of drug circulation will exceed the changes initiated almost 10 years ago by the adoption of Federal Law No. 61-FZ of 04.04.2010 “On the Circulation of Medicines”.

During the seminar, participants will be able to:

• understand the features of legal regulation and actions during the transition period,
• discuss changes in requirements and regulatory expectations regarding registration issues,
• Evaluate / outline the company's strategy for the registration of drugs during the transition period.

At the seminar will be considered:

• analysis of inspection practices for inconsistencies in the registration dossier;
• regulatory requirements and expectations regarding drug registration;
• practical aspects of bringing the registration dossier into conformity with the EAEU procedure.

Workshop Program >>

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