Editor's Notes: Monthly recap is a collection of China's pharmaceutical laws, regulations, policies, and standards recently 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 May 2023.
1. China to Tighten Regulation on Drug MAHs That Outsource Manufacture
2. China May Disallow ANDAs of Generic Drugs with No RLDs and Low Clinical Value
3. China Outlines Path for Adding Pediatric Medication Information to Authorized Drugs
4. China Greenlights One Rx-to-OTC Switch
5. China Releases Two RLD Lists
6. China Consults on Administrative Measures of Drug Standards
7. China Enhances Supervision of Anesthetics and Psychoactive Drugs Including Tramadol
8. Two Guideline Drafts Are Open to Public Comments
9. Chinese Pharmacopoeia Commission Issues Draft Standards
1. China to Tighten Regulation on Drug MAHs That Outsource Manufacture
On May 24, China NMPA issued the draft Notice of Enhancing the Supervision of Drug Marketing Authorization Holders (MAHs) That Outsource Manufacture (hereafter referred to as the Notice). The Notice came with an appendix: Guidance for On-site Inspection of Drug MAHs That Outsource Manufacture. The draft is open to public advice until June 23 this year.
The Notice stipulates that provincial medical products administration should conduct strict inspections of MAHs, with requirements specified in four aspects:
1) Manufacturing outsourcing authorization;
2) Quality management for outsourced manufacture;
3) Supervision and inspection of MAHs that outsource manufacture;
4) Others.
The Notice also elaborates MAHs’ obligations and responsibilities, whose summary can be found at BaiPharm News.
2. China May Disallow ANDAs of Generic Drugs with No RLDs and Low Clinical Value
On May 24, China CDE released the draft Notice of Generic Drug Study Without Reference Listed Drugs (RLDs) (hereafter referred to as the Notice). The draft states the precondition for developing copycats of drugs which are not listed in China’s RLD Catalog—the drugs have to be widely used, with no alternatives, and with benefits trumping risks. Find the details at BaiPharm News.
3. China Outlines Path for Adding Pediatric Medication Information to Authorized Drugs
On May 31, China NMPA released the Work Procedures for Adding Pediatric Information to Medication Package Inserts of Authorized Drugs (Trial) with immediate effect.
The regulation only allows qualified pediatric-related medical institutions, academic societies, and industry associations to propose the addition of the pediatric medication information. Learn about the addition procedures at BaiPharm News.
4. China Greenlights One Rx-to-OTC Switch
On May 31, China NMPA announced that the status of Metronidazole and Chlorhexidine Lotion (Strong) was changed from prescription (Rx) drug to OTC drug. MAHs of this drug are required to revise the medication package inserts accordingly, then file the revision to local provincial-level medical products administration, and inform the relevant healthcare institutions and suppliers before Feb. 29, 2024. View the full OTC Catalog at BaiPharm Database.
5. China Releases Two RLD Lists
On May 6 and 12, China NMPA rolled out the 67th and the 68th lists of reference listed drugs (RLDs) respectively. The two lists cover 91 drugs in total, including Alcon Laboratories’ Polyethylene Glycol Eye Drops and Zhonghao Pharmaceutical’s Benvitimod Cream. View the full RLD Catalog at BaiPharm Database.
6. China Consults on Administrative Measures of Drug Standards
On May 5, China NMPA publishes the revised draft of Administrative Measures of Drug Standards (hereafter referred to as the Measures). According to the Measures, national drug standards refer to standards written in the Chinese Pharmacopoeia (ChP). Drug registration standards are proposed by drug applicants and approved by NMPA.
When a new version of ChP comes into effect, drug MAHs should keep aligned with the new national drug standards. If the drug registration standards used by the MAH are lower than the national ones, the MAH should submit a supplemental application, filing request, or report to CDE or provincial medical products administration. If the MAH needs to follow a drug registration standard inconsistent with the national drug standards, it should submit a supplemental application to CDE following as strict risk management principle as possible.
7. China Enhances Supervision of Anesthetics and Psychotropic Drugs Including Tramadol
In April 2023, China NMPA adjusted the Catalogs of Anesthetics and Psychotropic Drugs, adding tramadol combination preparation, etazocine, and perampanel (including the latter two’s salts, isomers, and single agent preparations) to the Catalog of Psychotropic Drugs (Category II).
On May 23, NMPA issued more requirements on these three drugs: manufacturers of tramadol, etazocine, and perampanel should apply for manufacturing qualification to the local provincial medical products administration, and file the production plan for 2023. Companies that fail to obtain the qualification or file the plan will not be permitted to produce the three drugs. The new requirements will take effect on July 1, 2023.
8. Two Guideline Drafts Open to Public Comments
No. | Draft Guidelines | Authority | Issued |
1 | ICH & CDE | 10/05/2023 | |
2 | ICH & CDE | 29/05/2023 |
9. Chinese Pharmacopoeia Draft Standards
In May 2023, the Chinese Pharmacopoeia Commission issued the following drug standard drafts for public comment.
No. | Draft Standard | Type | Issued |
1 | Guideline | 28/05/2023 | |
2 | Monograph | 06/05/2023 | |
3 | Monograph | 24/05/2023 | |
4 | Monograph | 29/05/2023 | |
5 | General Chapter | 30/05/2023 | |
6 | Monograph | 31/05/2023 | |
7 | Monograph | 31/05/2023 |
Contact BaiPharm if you’d like to know more about drug regulatory affairs in China.
