Nitrosamines impurities risk evaluation

CMDh raising risk awareness on Nitrosamine Impurities

On September 26th, 2019 the CMDh published the notice “Information on nitrosamines for marketing authorisation holders” asking to all Marketing Authorization Holders (MAHs) of human medicinal products containing chemically synthesised active pharmaceutical ingredients to evaluate the risk of the presence of nitrosamine impurities in their products. This includes generics and over-the counter (OTC) products.

Gilda D’Incerti at CoE for the Second International Week on Regulatory Affairs

The Federal Commission for the Protection against Sanitary Risks in Mexico (Comision Federal para la Proteccion contra Riesgos Sanitarios or COFEPRIS) is pleased to announce the launch of the Second International Week on Regulatory Science and Good Regulatory Practices, organized by the Center of Excellence in Regulatory Science and Good Regulatory Practices (CoE) in collaboration […]