Brazil’s Anvisa announces new flow for requesting copies of api and drug information
On May 11, 2020 Brazil’s ANVISA announces that the General Management of Drugs and Biological Products (GGMED) of Anvisa has a new flow for requesting and supplying copies of the registration process of drugs and active pharmaceutical ingredients (APIs).
Global Regulatory Partners is Joining the Fight Against Coronavirus (COVID-19)
Global Regulatory Partners is Supporting the Fight Against Coronavirus (COVID-19) -Contact US to Learn More
PMDA Approach to Artificial Intelligence (AI) based Medical Devices
PMDA has adapted emerging technologies such as AI based medical devices and has reviewed the registration process to make it more efficient.
The FDA publishes Guidance for Nutrition and Supplements Facts Labels for Small Entity Compliance
FDA publishes guidance for final rule intended to help small entities comply with the nutrition facts labeling requirements
The FDA publishes FY 2019 GDUFA Science and Research Report
The FDA’s FY 2019 GDUFA report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts.
HOW TO FILE A DMF FOR AN API IN JAPAN
GRP- blog explains the PMDA’s DFM application process and lists the necessary content needed for API submission to the PMDA.
Drug Master File (DMF) in China
The new system set up by the NMPA allows manufacturers to file the DMF directly, thereby reducing the approval time and respective cost involved.