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Preclinical Studies: Compliance with GLP

Order of the Ministry of Health of the Russian Federation of  01.04.2016 No 199н “On Approval of Good Laboratory Practice Rules” was registered on August 15, 2016 in the Russian  Ministry of Justice.

The new document establishes requirements to provide good quality of preclinical studies of drugs. Particular attention should be paid to the process of organization, planning and the principles of quality control of preclinical studies of drugs, reporting and archiving of results.

The guidelines are in full compliance with the legislation of Eurasia Economic Union member-states (EEU) and international good laboratory practice (GLP) guidelines.

The test of the order has been published at the official web-portal of legal information.

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