The Council of the Eurasian Economic Commission has amended the EAEU Good Manufacturing Practice (GMP) Rules, approved by Decision No. 77 of the EEC Council dated November 3, 2016. The document has been supplemented with requirements for the production of high-tech medicinal products and was developed taking into account best international practices and modern technologies.
Key additions
– New category of drugs: for the first time, the EAEU GMP Rules include specific requirements for the production of high-tech drugs.
– Harmonization of approaches: criteria for qualification and validation of production processes for this group of drugs have been unified.
– Removal of discrepancies: differences in production assessment that previously arose between the inspectorates of the Member States of the Union have been eliminated.
Mechanism of application
– Mutual recognition: the results of inspection assessments carried out by Member States and expert organisations remain valid when analysing module 3 of the registration dossier of advanced technology medicinal products.
– Single standard: manufacturers from all countries of the Union work according to identical requirements, which simplifies multi- siting and reduces transaction costs.
– International compatibility: approaches are based on advanced international experience.
Expected results
– Access to global markets: EAEU manufacturers gain a competitive advantage when supplying high-tech drugs abroad.
– Increased trust: strengthening the reputation of the Union’s pharmaceutical industry among potential trading partners.
– Quality assurance: strengthening the safety control system for drugs with complex molecular structures.
