Authorities at the European Economic Commission Council (EEC) have been making progress towards harmonising the registration and assessment of medicines for use in the Eurasian Economic Union (EAEU). Legislation that brings Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia under single national laws and legal codes are in force, superseding country-specific legislation. While the regulations mean new requirements for life sciences companies, they also create new opportunities for a single registration with access to all EAEU markets through a mutual recognition procedure.
The authorities began implementing requirements for biologics in January 2016, with the guidance in several areas, including pre-authorisation studies – non-clinical and clinical – registration procedures, and post-marketing activities.
ProductLife Group’s team of Russia-based experts have analysed the latest developments and requirements for non-clinical and clinical studies and the life cycle management of biologics for the initial registration and harmonisation with the EAEU requirement.