Editor's Notes: Monthly recap is a collection of China's recent pharmaceutical laws, regulations, policies, and standards, mainly 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.
For more details about the summarized contents below, please send an enquiry to contact@chemlinked.com.
1. China's 7th Volume-based Procurement Includes 327 Drug Products
On July 18, China National Joint Drug Procurement Office announced the official list of 327 drug products for the 7th volume-based procurement (VBP).1 217 bid-winning companies will supply the products to public health institutions. Among the companies, 6 are international enterprises—Hetero Labs, Bracco Sine, Almirall, Sandoz, and Pfizer. Please refer to BaiPharm's previous report for more details.
2. China NMPA Grants One Rx-to-OTC Switch
On July 11, China NMPA granted the OTC status to a former prescription drug Glucosamine Potassium Sulfate Tablets.2 View China's OTC medicine list at BaiPharm Database. Find out how to sell OTC drugs to China via cross-border e-commerce at BaiPharm Insight/Webinar.
3. China NMPA Issues the 56th List of RLDs
On July 22, China NMPA released the 56th list of reference listed drugs (RLDs), including Teva Pharmaceuticals' Floxapen, Novartis Japan K.K.'s Betoptic and other 72 drugs.3 RLDs are reference products to which that generic drugs shall be equivalent in quality and efficacy. View the RLD lists at BaiPharm Database.
4. China NMPA Implements Vaccine Manufacture & Distribution Rules
On July 8, China NMPA started implementing the Administrative Rules on Vaccine Manufacture and Distribution (hereafter referred to as the Rules).4 According to the Rules, China adopts the marketing authorization holder (MAH) system for vaccines. MAHs shall take the primary responsibilities for vaccine's safety, efficacy, and quality controllability, and manage the manufacture and distribution of vaccines. Check out more details at BaiPharm News.
5. China CDE Consults on Procedures for Starting For-cause Inspections
On July 7, CDE released the draft of Work Procedures for Initiating For-cause Inspections During Drug Review for public comments.5 For-cause inspections will be initiated by CDE if the drug application data are found to be suspiciously inauthentic or the drugs are reported to have problems during the review, and the issues need to be verified on site. When necessary, CDE can conduct sample tests.
Related Article: China to Initiate Pre-Approval Inspections Based on Risk Levels of Drug Registration Applications
6. China CDE Releases Q&As on Immediate Report of Adverse Drug Reactions (ADRs) in Clinical Trials
On July 19, CDE consulted on the Q&As on the Immediate Report of Safety Data During Drug Clinical Trials (Version 2.0).6 CDE clarifies the scopes of drugs and clinical trials for which applicants should immediately report the unexpected and severe ADRs that are confirmed/suspected to be relevant to the test drugs.
The involved drugs cover traditional Chinese medicines, chemical drugs, and biological products, including vaccines.
The clinical trials include:
Phase I/II/III clinical trials related to drug registration;
Bioequivalence studies approved according to investigational new drug (IND) applications;
Phase IV clinical trials particularly required in the drug approval document;
Clinical trials required for drugs with conditional approval.
Clinical trials required for marketed drugs that apply for adding a new target group or a new indication.
Clinical trials required for marketed drugs that have major variations (e.g. new dosage form, new administration route, new manufacturing technique, etc.)
Time limits7 for the immediate reports:
For unexpected and severe ADRs that are deadly or life-threatening, the applicant should report them as soon as possible—no later than the 7th day from the first knowledge* of the ADRs. The applicant should complete the follow-up information in the subsequent 8 days after the report date.
For unexpected and severe ADRs that are neither deadly nor life-threatening, the applicant should report them as soon as possible—no later than the 15th day from the first knowledge of the ADRs.
*The first knowledge means that the applicant has known about the ADRs for the first time. The day when the applicant gets the first knowledge is defined as the zeroth day.
Related Article: China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports
7. Pharmaceutical Guidelines/Standards
No. | Guidelines/Standards | Authority | Status | Release Date |
1 | Guidelines on General Considerations for Organizing Patients to Joining in Drug Development | CDE | Draft | July 6 |
2 | Technical Guidelines on Antibody-drug Conjugates (ADCs)' Non-clinical Researches | CDE | Draft | July 6 |
3 | CDE | Draft | July 7 | |
4 | Guidelines on the Design and Plan Framework of Real World Studies on Drugs | CDE | Draft | July 7 |
5 | Technical Guidelines on Bioequivalence Studies on Amphotericin B Liposome for Injection | CDE | Draft | July 7 |
6 | Guidelines on Clinical R&D of New Drugs for Acute Myeloid Leukemia (AML) | CDE | Draft | July 19 |
7 | Technical Guidelines on Drug Registration Based on Animal Rules | CDE | Draft | July 22 |
8 | CDE | Draft | July 25 | |
9 | CDE | Draft | July 29 | |
10 | Chinese Pharmacopoeia (ChP) Commission | Revised Draft | July 7 | |
11 | ChP Commission | Revised Draft | July 7 | |
12 | ChP Commission | Draft | July 7 | |
13 | ChP Commission | Draft | July 7 | |
14 | ChP Commission | Draft | July 7 | |
15 | 9650 Research Guidelines on Sealing Properties of Pharmaceutical Packaging Systems | ChP Commission | Draft | July 11 |
16 | *No. 16-40 are draft standards of pharmaceutical packaging materials 5510 General Chapter on Prefilled Syringes | ChP Commission | Draft | July 11 |
17 | 5511 General Chapter on Glass Barrels of Prefilled Syringes | ChP Commission | Draft | July 11 |
18 | 5512 General Chapter on Plastic Barrels of Prefilled Syringes | ChP Commission | Draft | July 11 |
19 | 5513 General Chapter on Stainless Steel Needles of Prefilled Syringes | ChP Commission | Draft | July 11 |
20 | 4040 Test for Luer Taper of Prefilled Syringes | ChP Commission | Draft | July 11 |
21 | 4041 Sealing Property Test for Protective Caps of Prefilled Syringes | ChP Commission | Draft | July 11 |
22 | 4042 Pull-off Force Test for Protective Caps of Prefilled Syringes | ChP Commission | Draft | July 11 |
23 | 4043 Sealing Property Test for Pistons of Prefilled Syringes | ChP Commission | Draft | July 11 |
24 | 4044 Unscrewing Torque Determination for Luer Lock Rigid Tip Caps of Prefilled Syringes | ChP Commission | Draft | July 11 |
25 | 4045 Torsion Resistance Determination for Adapter Collars of Prefilled Syringes | ChP Commission | Draft | July 11 |
26 | 4046 Pull-off Force Determination for Adapter Collars of Pre-filled Syringes | ChP Commission | Draft | July 11 |
27 | 4209 General Chapter on the Determination of Ethylene Oxide in Pharmaceutical Packaging Materials | ChP Commission | Draft | July 11 |
28 | 4226 Determination of Tungsten Dissolution Amount in Prefilled Syringes | ChP Commission | Draft | July 11 |
29 | 4227 Determination of Silicone Oil in Prefilled Syringes | ChP Commission | Draft | July 11 |
30 | 5200 General Chapter on Rubber Closures for Pharmaceutical Packaging | ChP Commission | Draft | July 13 |
31 | 5201 General Chapter on Rubber Closures for Injections' Packaging | ChP Commission | Draft | July 13 |
32 | 5202 General Chapter on Rubber Closures for Oral Dosage Forms' Packaging | ChP Commission | Draft | July 13 |
33 | 4204 Determination of Extractables and Leachables of Pharmaceutical Packaging Materials | ChP Commission | Draft | July 14 |
34 | 4206 Determination of Insoluble Particles in Pharmaceutical Packaging Materials | ChP Commission | Draft | July 15 |
35 | 4214 Determination of Metal Elements and Ions in Pharmaceutical Packaging Materials | ChP Commission | Draft | July 16 |
36 | 4219 Determination of Volatile Sulfide in Rubber Closures | ChP Commission | Draft | July 17 |
37 | 4220 Determination of Ash Content in Rubber Closures | ChP Commission | Draft | July 18 |
38 | 4221 Determination of Water Content in Rubber Closures | ChP Commission | Draft | July 19 |
39 | 4222 Determination of Silicone Oil on the Surface of Rubber Closures | ChP Commission | Draft | July 20 |
40 | 4223 Determination of Special Residues in Silicone Rubber Closures | ChP Commission | Draft | July 21 |
41 | ChP Commission | Revised Draft | July 20 | |
42 | ChP Commission | Draft | July 20 | |
43 | ChP Commission | Draft | July 20 | |
44 | ChP Commission | Revised Draft | July 20 |
Read More
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2022
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