In the EAEU, trials duplication will be reduced in respect of pharmaceutical production transfer


According to EAEU press service, the Board of the Eurasian Economic Commission approved the guidelines for the member states of the Union on the transfer of production and analytical methods in pharmaceutical drugs manufacturing.

“The document will reduce the number of redundant studies in situations when medicines production is transferred, without compromising the quality and safety of the products”, the report states.

The Guidelines also regulate the documentation of the process of manufacturing transfer from one site to another and quality control of medicines, and provides explanations on the necessary sequence of actions in the organization. The document can also be used in other biomedical applications, for example, when transferring analytical techniques between clinical laboratories.