Editor's Notes: Monthly recap is a collection of China's laws, regulations, policies, and standards on medicines, including chemicals and biologics. Generally, they are issued by the these 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 July 2023.
1. China Publishes Administrative Measures for Drug Standards
2. China Announces Customs Codes of Anesthetics and Psychotropic Drugs
3. China Rolls out the 70th RLD List
4. China Grants Four Rx-to-OTC Switches
5. China Revises Drug Inspection Regulation
6. China Issues Draft Regulation on Inspection of Clinical Trial Institutions
7. China Releases Pharmaceutical Guidelines
8. China Consults on Drafts of Drug Standards
1. China Publishes Administrative Measures for Drug Standards
On July 5, China NMPA issued the Administrative Measures for Drug Standards, which will take effect on Jan. 1, 2024. China’s drug standards refer to any of the following three standards：
1) National drug standards in the Chinese Pharmacopoeia; drug standards issued by NMPA;
2) Drug registration standards proposed by drug registration applicants, then verified and determined by CDE;
3) TCM standards made by provincial medical products administrations.
Find out what drug applicants and marketing authorization holders should do about drug standards at BaiPharm News.
2. China Announces Customs Codes of Anesthetics and Psychotropic Drugs
On July 5, China NMPA and the General Administration of Customs (GACC) declared the customs codes for oliceridine, an anesthetic, as well as suvorexant, perampanel, eptazocine, and tramadol, four psychotropic drugs.
China has been reining in the supervision of tramadol, etazocine, and perampanel. Starting on July 1 this year, manufacturers of the three drugs must apply for manufacturing qualification to be recognized by the local provincial medical products administration, and file the production plan for 2023.
Get more details at BaiPharm News.
3. China Rolls out the 70th RLD List
On July 17, China NMPA released the 70th list of reference listed drugs (RLDs), including 21 drugs, e.g., AstraZeneca's Sodium Zirconium Cyclosilicate Powder, Biohaven's Rimegepant Sulfate.
View the full RLD catalog at ChemLinked BaiPharm Database.
RELATED: China Abbreviated New Drug Application (ANDA) for Generic Drugs
4. China Grants Four Rx-to-OTC Switches
On July 25, China NMPA announced Rx-to-OTC switches of four traditional Chinese medicines (TCMs):
Notes: Texts in the four parentheses below are Chinese Pinyin of the TCMs’ names.
1) Yinhuang Buccal Tablets (Yinhang Hanpian)
2) Sleep-benefiting Combination Preparation (Mian’anning Heji)
3) Jingtian Acne-ameliorating Tablets (Jintian Quban Pian)
4) Xinghe Cough-relieving Syrup (Xinghe Zhike Tangjiang)
View the full OTC drug catalog at ChemLinked BaiPharm Database.
RELATED: China Updates Documentation Requirements for Rx-to-OTC Switch Applications
5. China Revises Drug Inspection Regulation
On July 21, 2023, China NMPA released the revised Administrative Measures for Drug Inspections (Trial) (hereafter referred to as the Inspection Measures) with immediate effect. The revisions mainly took place in “Chapter 3 Inspection Procedures” and “Chapter 9 Handling of Inspection Conclusion”.
The Inspection Measures, first issued in May 2021, has replaced two abolished regulations—Administrative Measures on the Certification of Good Supply Practices (GMP) for Drugs and Administrative Measures on the Certification of Good Manufacturing Practices (GSP) for Drugs.
The Inspection Measures, first issued in May 2021, has replaced two abolished regulations—Administrative Measures Good Supply Practices (GMP) Certification and Administrative Measures on Good Manufacturing Practices (GSP) Certification, as China has cancelled the GMP and GSP certifications since the revised Drug Administration Law took effect in 2019.
Get more details at BaiPharm News.
6. China Issues Draft Regulation on Inspection of Clinical Trial Institutions
On July 3, China released the draft of Supervision & Inspection Measures for Drug’s Clinical Trial Institutions. The inspections are divided into four categories:
Inspection | Definition |
The first Inspection after filing | For clinical trial institutions that have just filed their information to NMPA, or have just changed the filed information (e.g., to add a new academic discipline involved in the clinical trial, a change of the institution’s address, etc.) Conducted within 60 workdays after the first filing or the change to the filed information. Focusing on verifying the filed information. |
Routine inspection | Made based on the annual inspection plan and in consideration of risks and randomness. Focusing on whether the institution comply with laws, regulations, and GCP, and whether it has corrected the deficiencies found in previous inspections. |
For-cause inspection | Targeted at institutions that have problems with potential safety risks, or are complained or reported to have illegalities. Possibly with no notification in advance. |
Other inspection | Other inspections other than the above three. E.g., random inspection by NMPA, and special inspection by provincial-level regulators. |
RELATED: China GLP Certification Regulation Takes Effect on July 1, 2023
7. China Releases Pharmaceutical Guidelines
In July 2023, China drug regulators issued the following guidelines:
8. China Consults on Drafts of Drug Standards
In July 2023, the Chinese Pharmacopoeia Commission released the following draft standards.
No. | Draft Standard | Type | Consultation Period |
1 | Excipient monograph | 26/07/2023-25/10/2023 | |
2 | Excipient monograph | 28/07/2023-27/10/2023 | |
3 | Combination Pumpkin Yangyin Granules (Fufang Nangua Yangyin San) | TCM monograph | 07/07/2023-07/10/2023 |
4 | TCM monograph | 07/07/2023-07/10/2023 | |
5 | TCM monograph | 08/07/2023-07/10/2023 | |
6 | TCM monograph | 13/07/2023-13/08/2023 | |
7 | TCM monograph | 13/07/2023-13/08/2023 | |
8 | TCM monograph | 13/07/2023-13/08/2023 | |
9 | TCM monograph | 13/07/2023-13/08/2023 | |
10 | TCM monograph | 26/07/2023-25/10/2023 | |
11 | TCM monograph | 28/07/2023-28/08/2023 |
Contact BaiPharm if you’d like to know more about China's drug regulations.
