On September 5, 2019, on the legal portal of the Eurasian Economic Union docs.eaeunion.org, the Recommendation of the ECE Board No. 25 “On the Guidelines for the Preclinical and Clinical Development of Combined Medicines” was published.
According to the provided information, after 6 months from the date of publication of the Recommendation, it is necessary to apply this Guide in the following cases:
- in preclinical and clinical development of combination drugs;
- the formation of a registration dossier for a combination drug;
- examination of relevant documents;
- when registering and amending the registration dossier for a combination drug.
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 does not represent effective combinations in terms of evidence-based medicine.