About regulation for drugs (pharmaceuticals for human use) in Russia. Topics:

1 – Introduction (what is it drug and how to determine border line products),

2 –  Drug registration process for Russian market (national approval),

3 – EAEU regulation for drugs – how to receive state registration,

4 – Introduction of pharmaceutical substance to GRLS,

5 – Permission for clinical trials.

6 – International experience of the harmonization of registration process for pharmaceuticals for human use

7 – Preclinical studies of drugs. General information

8 – About generics

9 – Interchangeable drugs

10 – Pharmacovigilance – general information.

11 – Orphan diseases

12 – Electronic Common Technical Document

13 – Omics technologies

14 – Renewal of the drug registration within the framework of national regulation

15 – Nomenclature of medicines within the framework of registration according to the rules of the EAEU

16 – Bringing the registration dossier into line with the requirements of the EAEU

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©Beawire – March 2019 with updates from January 2020.