The EEC Council supplemented the EAEU Good Manufacturing Practice Rules with requirements for manufacturing advanced therapy medicinal products, drawing on international practice and modern production technologies. Source: Eurasian Economic Commission (EEC).
Aligned approaches to qualification and validation of such production should remove differences in assessments by member states’ pharmaceutical inspectorates. Mutual recognition of inspection findings when reviewing module 3 of registration dossiers for advanced therapies remains in place.
Union manufacturers gain a clearer path to international markets; the update strengthens quality assurances and trading partners’ confidence in the EAEU pharmaceutical sector. The baseline document is EEC Council Decision No. 77 of 3 November 2016.