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

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©Beawire – March 2019 with updates from May 2019.