Pharmaceuticals for human use
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
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
___
©Beawire – March 2019 with updates from January 2020.