EEC approved a number of documents for the common market of medicines

| By | Clinical Trials, EAEU, EEC

The College of the Eurasian Economic Commission (EEC) approved the Guidance on Analytical Method Validation:

The Guidance defines approaches to validation of the four most common types of tests, including the identification (verification of identity), quantitative tests for impurities’ content, limit tests for the control of impurities, and quantitative determination of concentration or activity of the active substance in the medicinal product.

In addition, the document describes the situations when revalidation of the methods should be performed. Such revalidation is required due to change in the synthesis scheme of pharmaceutical substance or composition of medicinal product.

Using validated methods for quality control will ensure the withdrawal of unsafe drugs from circulation before they enter pharmacy chains and may be purchased by patients.

EEC College adopted the Guidance on General Issues of Clinical Trials:

The College of the Commission recommended that the EAEU members use this document for the drugs trials for their further registration under the Rules of Registration and Expert Examination of Medicinal Products for Human Use.

The Guidance defines basic principles for planning and conducting clinical trials of medicinal products, including the protection of human subjects. In particular, for the safety of the study participants, the results of emerging toxicological and clinical studies should be taken into account during new drug development.

In addition, the document contains a unified classification of clinical trials and recommendations on the number of patients in the safety population used for the analysis of medicinal product safety.