The Russian Ministry of Health has developed amendments to the Regulation on the Federal Service for Surveillance in Healthcare. The draft was prepared to implement the Agreement on Common Principles and Rules of Circulation of Medical Devices and Medicines in the Eurasian Economic Union (EAEU). The draft provides for the formation of common markets for medical devices and medicines within the Eurasian Economic Union and the adoption of measures necessary for the harmonization and unification of the legislation of member states of the Union in the sphere of circulation of medical devices and medicines. The draft document is available at: https://regulation.gov.ru/projects#npa=106260.
The list of proposed changes:
– Inspection of testing laboratories and audits of preclinical (non-clinical) studies of medicines for compliance with the Good Laboratory Practice (GLP) Rules of the EAEU.
Thanks to this change the authorized bodies will check the procedures and practices of the laboratory to assess compliance with the principles of GLP.
There also appeared a similar point for inspection of clinical trials according to the Good Clinical Practice (GCP) rules.
– Implementation of inspection of organizations conducting clinical trials of medicines for compliance with GCP.
Within the framework of this inspection, the authorized bodies inspect documents, infrastructure, records, quality assurance agreements, and any other sources which are considered by the authorized body as relevant to the study and which may be located in the research center, facilities of the sponsor and/or contract research organization or in other organizations which, in the opinion of the authorized body, require inspection.
The next point of amendments concerns compliance with the implementation of the Good Distribution Practice (GDP) Rules.
– Verification of compliance of subjects of circulation of medicines for medical use with proper conditions for storage, transportation, and distribution of medicines according to GDP.
In addition, as part of these changes were added paragraphs regulating the implementation of pharmacovigilance by Good Pharmacovigilance Practice (GVP).
– Conducting pharmacovigilance inspections of licensees or other organizations engaged by licensees to perform pharmacovigilance obligations.
– Monitoring the safety, quality, and effectiveness of medical devices by the Rules for monitoring the safety, quality, and effectiveness of medical devices, approved by the decision of the Eurasian Economic Collegium on December 22, 2015, № 174;”.
Thus, the approval of these changes, on the one hand, will harmonize and unify the legislation of EAEU member states, and, on the other hand, ensure compliance with GLP, GCP, GDP, and GVP rules in our country.