The overseas generic pharmaceutical industry from the ICH region (USA, Japan, European Union) and 'pharmerging' countries have good opportunities to gain profits in Russia, despite the strong governmental support of local drug manufacturers.
It is expected the rules of the Eurasian Union (EAEU) on medicines' registration, examination and bioequivalence investigation will actually work in 2018. They will be very close to the EU guidelines, contract research organization ARS PharmRussia explains.
The legislation will allow drugmakers to register a medicine based on their own clinical research data obtained in ICH countries before 2016; a reference product may originate from ICH countries, not compulsory from Russia; bio-waivers will be applicable for BCS class I and III drugs in immediate-release oral solid dosage forms; etc.
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