Editor's Notes: Monthly recap is a collection of China's recent pharmaceutical laws, regulations, policies, and standards issued by the following authorities:
National Medical Products Administration (NMPA);
NMPA's Center for Drug Evaluation (CDE);
National Health Commission (NHC);
National Healthcare Security Administration (NHSA);
National Joint Drug Procurement Office;
Chinese Pharmacopoeia (ChP) Commission.
The following are the regulatory updates in Feb. 2023:
1. China NMPA Issues TCM Registration Rules
2. China CDE Rolls Out Pharmaceutical Guidelines
3. Chinese Pharmacopoeia Commission Issues Draft Standards
1. China NMPA Issues TCM Registration Rules
On Feb. 10, 2023, NMPA released the Special Rules for the Administration of Traditional Chinese Medicine (TCM) Registration (hereafter referred to as the Special Rules), which will take effect on July 1, 2023.
The Special Rules has 11 chapters1:
Chapter I: General Provisions
Chapter II: TCM Classification and Marketing Authorization Review
Chapter III: Appropriate Application of Human Use Evidence
Chapter IV: Innovative TCM
Chapter V: Improved new TCM
Chapter VI: Combination TCM in Ancient Classical Prescription
Chapter VII: Medicines with the Same Name and Formulation
Chapter VIII: Post-approval Changes
Chapter IX: TCM Registration Standards
Chapter X: Drug Name and Medication Package Insert
Chapter XI: Supplementary Provisions
The Special Rules requires that TCMs, like chemical drugs and biological products, should be clinical-value-oriented. The Special Rules also recognizes TCMs’ special characteristic—abundant human use experience embodying effectiveness and safety information.
2. China CDE Rolls Out Pharmaceutical Guidelines
In Feb. 2023, China CDE published a series of home-drafted guidelines and a guideline of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) with Chinese translation.
3. Chinese Pharmacopoeia Commission Issues Draft Standards
In Feb. 2023, Chinese Pharmacopoeia Commission released the following draft standards for public comments.
Regulation/policy coming into effect in Mar. 2023:
Contact BaiPharm if you need more details of the summarized contents above.