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.