Editor's Notes: Monthly recap is a collection of China's laws, regulations, standards, and policies on chemical drugs and biological products. Generally, the regulatory updates are from these authorities:
National Medical Products Administration (NMPA);
Center for Drug Evaluation (CDE), NMPA;
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 June 2024.
1. China CDE Solicits Public Comments on the 83rd and 84th RLD Lists
In June, China CDE consulted on the draft of the 83rd and 84th lists of reference listed drugs (RLDs), encompassing 18 products and 27 products, respectively. Specifically, the products include Ciprofol Injection, Diazepam nasal spray, Clobazam Oral Flim, Ripretinib Tablets, Zuranolone Capsule, etc.
2. China CDR Invites Public Feedback on the Draft Procedure for Converting Prescription Drugs to OTC Drugs
On June 7, China Center for Drug Reevaluation (CDR) under the NMPA issued the Procedure for Converting Prescription Drugs to OTC Drugs (Draft for Comments) to facilitate the technical evaluation process for the conversion. Any prescription drugs in China that are proposed to be switched to OTC status must be in line with this Procedure. Stakeholders can submit their feedback to [email protected] by July 7.
3. China NMPA Releases Three Documents on Blood Products
On June 11, the NMPA issued three important documents related to blood products:
4. China CDE Releases Dossier Requirements for Imported Therapeutic Biological Products' Transfer to Domestic Production
On June 14, China CDE released the Dossier Requirements for Marketing Authorization Applications of Approved Imported (Therapeutic Biological Products) Drugs to Be Transferred to Domestic Production. According to the document, such products should be submitted for marketing authorization approval by local applicants based on the Class 3.4 therapeutic biological products. Applicants are required to conduct a preliminary self-assessment. If they determine that clinical trials can be waived, they may proceed with their application directly for marketing authorization approval. If clinical bridging trials are necessary, applicants must apply to such trials.
5. China NMPA Rolls Out the 81st RLD List
On June 17, the NMPA rolled out the 81st list of reference listed drugs (RLDs). The list encompasses 44 products, including Ritlecitinib Tosylate Capsules, Ritlecitinib Tosylate Capsules, Ritlecitinib Tosylate Capsules, etc.
For the complete RLD List, please refer to the BaiPharm Database.
6. China Lists 46 Substances as Non-Medical Anesthetic and Psychotropic Controlled Substances
On June 19, China announced the inclusion of 46 substances in the Supplementary List of Non-Medical Anesthetic and Psychotropic Controlled Substances, such as Bromadol, Metonitazene, Protonitazene, and others. This decision takes effect from July 1, 2024.
7. China Consults on New Policy to Expedite Approval of Clinically Urgent Overseas Drugs
In a move aimed at accelerating the approval process for clinically urgent overseas drugs, China's NMPA sought public feedback on June 25 regarding the Notice on Further Optimizing the Review and Approval of Clinically Urgent Overseas Drugs (Draft for Public Comment). Stakeholders are encouraged to submit their comments to the email address [email protected] by July 24, 2024.
8. NMPA Grants One Rx-to-OTC Switch
On June 25, NMPA granted the over-the-counter (OTC) status to one previous prescription drug, Beiqi Oral Solution (Beiqi Koufuye).
For the complete OTC catalog, please refer to the BaiPharm Database.
9. China NMPA Implements International Guidelines for Drug Registration
On June 25, the NMPA announced its decision to adopt the ICH Q3C(R9) “Guideline for Residual Solvents”. Applicants are required to conduct research based on the current technical requirements for pharmaceutical research and adhere to Q3C (R9). The guideline apply to all relevant studies initiated on or after June 20, 2024, as documented in the trial records.
10. China Releases HS Codes for Dextromethorphan, Nalfurafine, and Lorcaserin
In response to the classification of Dextromethorphan, Nalfurafine, and Lorcaserin in China's psychotropic drugs catalog, China's NMPA and Customs jointly released the HS codes for customs clearance on June 26.
Name | CAS Number | HS Code |
Dextromethorphan | 125-71-3 | 2933490023 |
Dextromethorphan single formulation (pre-measured doses or packaged for retail sale) | 3004909049 | |
Nalfurafine | 152657-84-6 | 2939190026 |
Nalfurafine single formulation (pre-measured doses or packaged for retail sale) | 3004490094 | |
Lorcaserin | 616202-92-7 | 2933990024 |
Lorcaserin single formulation (pre-measured doses or packaged for retail sale) | 3004909049 |
11. NHSA to Adjust the 2024 National Reimbursement Drug List (NRDL)
On June 28, the China National Healthcare Security Administration (NHSA) released the 2024 Work Plan for Adjusting the National Reimbursement Drug List (NRDL).
Applicants are required to submit their applications through the online service platform (website: https://fuwu.nhsa.gov.cn/). The online application period is from 9:00 AM on July 1 to 5:00 PM on July 14, 2024, after which the application portal will close automatically.
12. China Releases Pharmaceutical Guidelines
In June 2024, China unveiled the following guidelines on chemical drugs and biological products.
13. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
In June 2024, the Chinese Pharmacopoeia Commission released 62 draft standards on chemical drugs, biological products, active pharmaceutical ingredients (APIs), excipients, packaging materials, and determination methods.
Parts of the 62 draft standards
No. | Draft standard | Type | Consultation |
1 | Monograph-excipient | 2024/06/04-2024/08/04 | |
2 | Monograph-excipient | 2024/06/07-2024/08/07 | |
3 | Monograph-chemical drug | 2024/06/11-2024/08/11 | |
4 | Monograph-chemical drug | 2024/06/11-2024/08/11 | |
5 | Monograph-chemical drug | 2024/06/11-2024/08/11 | |
6 | Monograph-chemical drug | 2024/06/11-2024/08/11 | |
7 | Monograph-chemical drug | 2024/06/11-2024/08/11 | |
8 | Monograph-biologics | 2024/06/18-2024/08/18 | |
9 | Monograph-chemical drug | 2024/06/18-2024/07/19 |
Contact BaiPharm if you are interested in learning more about the draft standards or other drug registration regulations in China.
