Drug Registration within EEU: The Question Has Not Been Solved Yet
3rd practical conference “Drug Launch to the Market of Russia and CIS” was held last week in Moscow. Legislation initiatives of legal regulation in the pharmaceutical industry were discussed at the conference.
The list of participants of the conference included representatives of department of technical regulation and accreditation of the Eurasia Economic Commission, the Association of Internaitonal Pharmaceutical Manufacturers, Working Group on General Approaches to Regulation of Drug Circulation in the EEU, EEU Institute, Center for study and analysis of human problems, demography and healthcare, as well as I.M. Sechenov First Moscow State Medical University and Institute of Toxicology at the Federal Biomedical Agency
The participants noted significant changes in the sphere of pharmaceutical industry which is on the way of innovative development in the EEU. That statement included a notion of significance of interpretation of norms and principles of functioning of the common space in the complicated period as particular focus is made on functions of the regulatory mechanism and analysis of prospects of further development of pharmaceutical industry.
Conference participants paid particular attention to the issue of drug authorization. The issue has not yet been olved. Speaking to the conference participants deputy head of Department of Technical Regulation and Accreditation of EEU Dmitry Rozhdestvensky told that at the meeting of EEU held on March 17, the document on drug registration in the EEU was not passed . “It is the issue of drug interchangeability, he says. Russia insists that registration documents contain a statement on it. The other countries are in opposition”.
To give start to the single market of drugs in EEU 23 regulatory documents should be accepted. Although they had to be approved by the end of 2015, only four regulatory acts have been approved so far, The rest are currently under development. The most long-expected act concerns drug authorization.
Now that relevant vice-premier ministers of EEU member states have undertaken to solve the problem, there is a hope that it will be solved in a few weeks to come.