Until 2018, the Eurasian Economic Union (EAEU) will adopt 67 “third-level” documents to ensure high quality of safe drugs for the EAEU patients.
The list and adoption status of the documents ensuring drug quality were reviewed at the session of an expert task-force of Eurasian Economical Commission (EEC). This is a number of related guidelines and recommendations regarding manufacturing and study of drug groups and compiling a regulatory dossier.
The task-force members discussed two of the documents in details: draft Guidance on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin and draft Guidance on Analytical Method Validation. For instance, Validation Guidance allows the manufactures to verify the ability of drugs quality control methods to identify deviation from the specified standard.
Russian pharmaceutical companies such as Pharmstandard PJSC, Rozlex Pharm LLC, Gedeon Richter JSC, and representatives of professional associations proposed a pilot project aimed at registration of several medicinal products within a common EAEU market. It is essential for mastering the procedures of expert valuation and interaction of expert organizations of the state-members for the assessment of a pharmaceutical product dossier.