On January 2023, the CMDE issued Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries.
China’s NMPA issues four technical guidelines for bioequivalence studies of specific varieties
China’s NMPA Announces Good Practice for Timing Termination and Restoration of Review in the Process of Drug Evaluation
On November 8, 2022, the CDE issued a notice on “Questions and Answers for Dissolution Profile Studies ⟨Technical Guidelines for Pharmaceutical Change Studies of Marketed Chemical Drugs (Trial) ⟩”
On November, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
On December 2022, a new template Drug Export Sales Certificate has been launched, which conforms to the format recommended by the World Health Organization (WHO). Electronic certificates have the same effect as paper certificates.
On November 2022, the NMPA issued the Announcement on “Appendix to Good Operating Practices for Medical Devices: quality Management of Enterprises Providing Transportation and Storage Services for Medical Devices”.
China’s NMPA Announces they will Start Electronic system for Drug related Registration Certificates (2022)
China’s NMPA Announces they will start on Issuance of Drug Electronic Registration Certificates starting November 1st, 2022. China’s National Medical Products Administration (NMPA) will issue drug registration certificates in electronic version, which is as legally valid as the paper version.
China’s NMPA Releases draft on the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China.
On May 9, 2022, The General Department of the National Medical Products Administration (NMPA) issued draft guidance on Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China.
A Local Agent in China is legal representative of overseas pharmaceutical and medical devices companies required as per the NMPA regulations.
On May 2022, the US-FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the new Accelerating Rare disease Cures (ARC) Program.
China’s CDE- Guidelines for Summary of Adverse Drug Reaction Data in Labeling of Antineoplastic Drugs
China’s CDE issued on March 21st, 2022 the guidelines for the listing Adverse reaction in package inserts.