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.
China New Requirements for Local Testing of Foreign Class II and Class III Medical Device
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”
Registration of Imported Pet food in China
If an overseas pet feed manufacturer exports pet compound feed or pet additive premix feed to China, it shall entrust an overseas enterprise’s office in China or an agency in China to apply for registration with the agricultural administrative department of the State Council and obtain an import registration certificate in accordance with the law.
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 […]
NMPA publishes new guideline for faster approval of Medical Device
China’s State Council publishes a new Medical Device Regulation (Order no. 739) to follow conditional approvals on rare diseases treating medical devices
NMPA releases a final guidance on Device Master File (DMF) submissions
As per the Announcement no. 36 of 2021, lists requirements for voluntary submission of domestic Class III and imported Class II and III medical devices and IVDs.
New Rules for Cosmetics Registration in China starting May 2021
The new regulations on cosmetics in china are coming into effect on May 1st, 2021. They include new classification of cosmetic product, new requirements for the ingredients, labeling, safety assessment and animal testing.
Anvisa will begin monitoring prices of medical devices
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
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.
Anvisa signs agreement with European Medicines Agency (EMA)
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
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.