Pharmaceuticals for human use
About regulation for drugs (pharmaceuticals for human use) in Russia.
Articles:
- Introduction (what is it drug and how to determine border line products)
- Drug registration process for Russian market (national approval)
- EAEU regulation for drugs – how to receive state registration
- Introduction of pharmaceutical substance to GRLS
- Permission for clinical trials
- International experience of the harmonization of registration process for pharmaceuticals for human use
- Preclinical studies of drugs. General information
- About generics
- Interchangeable drugs
- Pharmacovigilance – general information
- Orphan diseases
- Electronic Common Technical Document
- Omics technologies
- Renewal of the drug registration within the framework of national regulation
- Nomenclature of medicines within the framework of registration according to the rules of the EAEU
- Bringing the registration dossier into line with the requirements of the EAEU
©Beawire – March 2019 with updates from January 2020.