Since 30.10.2017, the obligatory provision for applicants in drug registration and re-registration is to provide a Risk management plan (read more details in sеction Pharmacovigilance) and clinical data addenda (DCRA, see more details in section Drug clinical review addendum (DCRA). Nowadays, a 2-year transitional period is provided to applicants for preparation of the documents. Up читать дальше…


