The US FDA deems final Order for Sunscreens

On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.

Regulatory Overview: Registration of Toothpaste in China

On October 21, 2021, the Chinese health authority (NMPA) has published a new regulation related to the requirements of Local testing as part of medical devices registration in China: “Regulations on the Administration of Medical Device Registration and Self-inspection”

China eCTD Requirements: Coming into Effect December 2021

On September 29,2021, China Health Authority (NMPA) published the technical specifications of Electronic Common Technical Document (eCTD) for the initial New Drug Application (NDA) and Biologics License Applications (BLAs) that will come into effect by December 29, 2021.

FDA publishes ICH Q12 guideline for Post Approval CMC changes

Overview FDA facilitates the management of post approval CMC to harmonize regulatory approval of drugs with ICH Q12 guideline. This guidance applies to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization and to drug-device combination products that meet the definition of a pharmaceutical or biological product.  Regulatory tools and […]

How China’s NMPA Monitors Adverse Events due to Vaccines Handling

On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes”GRP Blog outlines how the NMPA reviews the application after receiving it and any necessary notes when preparing the application.

How China’s NMPA Review Application for Chemical Drug Changes

On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes”GRP Blog outlines how the NMPA reviews the application after receiving it and any necessary notes when preparing the application.