Transition to Compulsory Registration of Medicines According to the EAEU Rules: Start in Russia
- New reality: full transition of Russian regulatory authorities to registration of medicines according to the rules of the EAEU. Results achieved, hopes and concerns of regulators and pharmaceutical companies
- The Federal Law 61 and considerations in national legislation of procedures not provided for by the EAEU Rules. For example, assigning an orphan status to these types of drugs
- Conditional registration – introduction of new procedures in the EAEU
- Digital regulatory registers. Implementation of the registry model in the Russian Federation and relationship with the EAEU
- Feasibility of “simplifying” the alignment procedure. How can the principle of reasonable expediency be preserved?
- Typical requests from Russian regulators to pharmaceutical companies: how to avoid mistakes and reduce risks?
- Requirements for conducting GMP inspections as part of documents preparation for registration of medicines according to the rules of the EAEU. Extension of the validity period of national GMP certificates for registration of medicinal products according to the rules of the EAEU
- The perspective of pharmaceutical companies: experience of filing documents according to the rules of the EAEU. Successes, challenges facing pharmaceutical companies, and lessons learned
- What actions need to be taken by the regulatory bodies of Kazakhstan, Belarus, Armenia, and Kyrgyzstan in order to eliminate the risks in a complete transition to registration of medicines according to the rules of the EAEU in the next few months? Experience of the first registrations, concerns and difficulties
Wednesday, 28 April
- 15:10 - 16:40
- Transition to Compulsory Registration of Medicines According to the EAEU Rules: Start in Russia