Drug Master File Series Overview In mid 2019, NMPA implemented a new process for pharmaceutical excipients registration in China, manufacturers have to register the DMF

Drug Master File Series Overview Since July 2019, NMPA requires manufacturers of Pharmaceutical Packaging Materials (PPM) to register the DMF of their products using CDE

Overview In USA, the term “Orphan drug” has two definitions. The first describes drugs or biologics that are used for the prevention, diagnosis, or treatment

Overview A remote quality audit, also known as a QA e-audit, is similar to an on site quality audit, the only difference is that it

OVerview: ANVISA classifies radiopharmaceuticals in the following 3 categories: 1. Ready-to-use radiopharmaceuticals;2. Non-radioactive components used with radioactive components;3. Radionuclides, including eluates of radionuclide generators Download

Overview: On 03/18/2020, Anvisa published a new regulation (RDC 348/2020), that defines the conditions of the priority review for the registration of covid-19 Vaccines .