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Main  >  News  >  Another document in the formation of the regulatory framework of the EAEU single market for drugs

Another document in the formation of the regulatory framework of the EAEU single market for drugs

09/03/2019 | EAEU, drug registration

The Board of the Eurasian Economic Commission (EEC) examined issues in the areas of trade, macroeconomics, customs cooperation, business development, competition, digitalization, financial markets, technical regulation, circulation of medicines and medical devices in the countries of the Eurasian Economic Union (EAEU).

According to the information provided, the EEC Board recommended the EAEU countries to apply the Guidelines for the preclinical and clinical development of combination drugs. This is recommended when carrying out this development, forming a registration dossier for a combined medicinal product, conducting an examination of the relevant documents, as well as when registering and making changes to the registration dossier for a combined medicinal product.

The guidelines establish common approaches to the preclinical and clinical development of combination drugs (fixed drug combinations, fixed dosage drug combinations) containing two or more active substances in one dosage form.

The document contains recommendations on the drug development strategy, depending on the degree of novelty of the combination and the knowledge of the components of combined drugs. The development strategy prescribes the scope of preclinical studies of the safety and effectiveness of the combination, provides guidance on the choice of the type of clinical studies: studies of substitution of monotherapy, studies of the new effect of combination and bioequivalent studies.

The adoption of the guidelines will, on the one hand, help to reduce the costs of pharmaceutical manufacturers in the study of fixed combinations, and on the other, it will exclude the launch of combination drugs on the market that do not represent effective combinations in terms of evidence-based medicine.

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