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.
China’s CDE releases Guidelines for Acceptance and Review of 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” with Information on requirements for completing a Chemical Drug Change.
Rare Diseases in China: Approval and Coverage of Orphan Drugs
In December of 2020, the National Security Health Administration has also updated its annual list of drugs that are covered under the Basic Medical Insurance Plan.
Cosmetic Registration and Filing Management of new Cosmetic Materials in China Part II
On January 12,2021 China’s Health Authority, the NMPA released The Regulation “Measures of Cosmetics Registration and Filing Management” and will come into effect May 1, 2021.
Cosmetic Registration and Filing Management of new Cosmetic Materials in China Part I
On January 12,2021 China’s Health Authority, the NMPA released The Regulation “Measures of Cosmetics Registration and Filing Management” and will come into effect May 1, 2021.
Japan’s PMDA Remote Inspections
The PMDA clarifies its requirements for conducting remote compliance inspections related to drugs and regenerative medical products.
Australia’s TGA GMP inspections during COVID-19
During the duration of the COVID-19 pandemic, the TGA will only use remote and hybrid inspections to minimize potential impacts of on-site inspection of GMP clearance.
China’s NMPA Drafts new Regulations on Patent Linkages
China’s Patent Linkage Measures is a draft policy addresses market approval of generic drugs and the patent status of branded equivalents.
China’s CDE Releases guidance for the Technical requirements of Generic injections
China’s CDE releases guidance on the Technical Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Injections
China’s NMPA announces Delay of Unique Device Identification (UDI) Implementation
Due to the Coronavirus, Chinese Regulatory Authority, National Medical Products administration (NMPA). decided to delay UDI implantation to next year January 2021.
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.
China’s NMPA Addresses Common Period Risk Evaluation Report (PRER) Issues
China’s NMPA updates and address some common issues faced by the Marketing Authorization Holders to submit PRER report.