China’s NMPA Announces Good Practices for Review Timelines During the Drug Evaluation Process
China’s NMPA Announces Good Practice for Timing Termination and Restoration of Review in the Process of Drug Evaluation
China’s NMPA issues Notice on Technical Guidelines for Change Studies of Marketed Chemical Drugs
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) ⟩”
CHINA’S NMPA NEW REQUIREMENTS FOR SODIUM HYALURONATE
On November, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
China’s NMPA Announces Electronic versions of Drug & API Export Certificates are now available (2022)
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.
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On May 9, 2022, The General Department of the National Medical Products Administration (NMPA) issued draft guidance on Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China.
China’s NMPA: Local Agent in China for Foreign Pharmaceutical and Medical Device Companies
A Local Agent in China is legal representative of overseas pharmaceutical and medical devices companies required as per the NMPA regulations.
China NMPA Discloses No. 057 Reference Listed Drug (RLD) List for Public Industry Comments
China’s NMPA announced on March 25, 2022, the issue of the 57th batch of RLD (Reference Listed Drug) for public industry comments.
China’s CDE releases Technical Guideline Protocol Amendment during Clinical Trials
Overview: In order to better carry out the scientific supervision of risk-based clinical trials, according to the arrangements of the state bureau, our center CDE organized the drafting of the “technical guidelines for program change during drug clinical trials” and the drafting instructions. Introduction CDE has issued a draft technical guideline about protocol amendment during […]
China’s NMPA announces that it will expedite review applications for the marketing of Novel Drugs.
China’s CDE has released “Working Procedure for Accelerating the Review of Marketing Application of Innovative Drugs (Trial Implementation)”(hereinafter referred to as “Working Procedure”) for industry comments due March 4th, 2022.
China’s NMPA announces draft Guidelines on the Dossier Acceptance for Chemical Drug and Biologics.
China’s NMPA to improve the transparency and efficiency of the registration dossier acceptance and review, NMPA CDE issued a revision of the guidelines of the registration dossier acceptance for chemical drug and biologics, which is now ready for public comment due by March 4th, 2022.
China’s NMPA announces The First Regulation for Children’s Cosmetics – Coming into Effect January 2022
The new regulation on children cosmetics is becoming into effect on January 1st, 2022 “Regulation on Supervision and Administration of cosmetics for Children Cosmetics’ (ordinance No,123 of 2021), with the exception of the new labeling requirements for children’s cosmetic products that will come into force on May 1, 2022.
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”