New Anvisa rules Strengthen Regulation of Biologicals, Cosmetics and Health Products
The year 2025 has proved decisive for the evolution of the health regulatory framework in Brazil. With a focus on greater safety, traceability and modernization of systems, Anvisa has published new standards, technical updates and strategic guidelines that directly impact sectors such as biological products, cosmetics and health products.
Mexico’s Patent Office, COFEPRIS Sign Agreement on Drug Patents
Officials with Mexico’s patent office and its pharmaceutical regulator have signed a new agreement aimed at preemptively clarifying patent protections for drugs in hopes of speeding the review process.
China’s CDE publishes draft for a list of Drugs exempt from BE Studies
China’s CDE publishes draft listing 117 drugs that will be exempt from BE studies.
Changing of API registration in China NMPA- What you need to know
On January 17, 2020 The Center of Drug Evaluation has published a Notice on improving the relevant functions of the API registration system,