Updates on Pharmaceutical Regulations in China | June 2022
This 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. CDE Issues the 2021 China Drug Evaluation Report
On June 1, CDE issued the 2021 China CDE Drug Evaluation Report, revealing that 47 innovator drugs were approved in 2021. BaiPharm has selected critical information and compiled it into a report, which covers the following information:
- The accepted, reviewed, and approved drug applications;
- The expedited approvals;
- Onsite inspections;
- Approved medical products in significant therapeutic areas;
- Disapproval reasons;
- Reforms of the drug review & approval system.
ChemLinked BaiPharm members can download the report for free here.
2. CDE Publishes the 2021 Clinical Trial Report
On June 7, China Center for Drug Evaluation (CDE) published the 2021 Report on the Progress of Clinical Trials for New Drugs in China. According to the report, over 3,000 clinical trials were filed on CDE website, including 2,033 investigational and confirmatory clinical trials for new drugs.
During the past three years, among all the filed clinical trials, 54.6% and 40.4% were for chemical drugs and biological products respectively, according to annual average data. The indications were primarily neoplasms; the most popular targets were PD-1 and PD-L1. (Read More)
3. CDE Consults on Communication Procedures for Pediatric Drug Applicants
On June 21, CDE released the Work Procedures for the Application and Administration of Communication on Pediatric Drugs for public comment. The Work Procedures applies to pediatric drugs in any of the following categories:
- Drugs in the List of Pediatric Drugs Encouraged for R&D and Registration Application;
- Drugs whose target group are children and the indications have been listed as rare diseases by NHC and other authorities or recognized as major infectious diseases by NHC.
- Class 1 innovator drugs or class 2 improved drugs specially developed for children, including chemical drugs, prophylactic biological products, and therapeutic biological products.
- Drugs with overseas marketing authorization and pediatric use approval that are applying for pediatric use authorization in China and have high value for meeting the clinical treatment needs for pediatric patients in China.
When filling in the communication meeting application form, the applicant should specify which category the pediatric drug belongs to. If meeting the relevant requirements, CDE will adjust the meeting from class II to class I, thus shortening the waiting period between the application and the meeting from 60 to 30 workdays. (Read More)
4. CFDI Issues the 2021 Drug Inspection Report
On June 26, China Center for Food and Drug Inspections (CFDI), a public institution under National Medical Products Administration (NMPA), issued the 2021 Work Report on Drug Inspections, announcing that CFDI had completed 1,368 drug inspections in 2021. The inspections include 1,214 drug registration inspections, 101 drug supervision inspections, 6 overseas inspections, and 47 license inspections. (Read More)
5. NMPA Consults on GMP for Pharmaceutical Packaging Materials
On June 2, NMPA released the draft of Good Manufacturing Practice (GMP) for Pharmaceutical Packaging Materials for public comments. The draft specifies basic requirements for the manufacture management and quality control for pharmaceutical packaging materials. (Read More)
6. NMPA Releases the 55th RLD List
On June 30, China NMPA release the 55th List of Reference Listed Drugs (RLD), which includes 78 drugs such as Pohl-Boskamp’s Nitroglycerin Spray and Ferring Pharmaceuticals’ Dinoprostone Suppositories. Check out the RLD data at BaiPharm Database. (Read More)
7. NMPA Publishes Drug Traceability Specifications
On June 27, NMPA released the Identification Specification for Drug Traceability Code and the Display Specification for Consumer Query Results for Drug Traceability. The former will take effect on June 23, 2023, and the latter came into immediate effect. Both are meant for building a digital system for drug traceability. (Read More)
8. NMPA Encourages Companies and Third-Parties to Participate in Formulating & Revising TCM Standards
On June 14, NMPA solicited public opinions on the draft of Notice of Encouraging Companies and Third Parties to Participate in Formulating and Revising TCM Standards. According to the draft, TCM marketing authorization holders (MAH), manufacturers, combination entities of companies and research institutions, social groups, independent third-party institutions can contribute to TCM standards by proposing a research project related to the standards, offering testing samples for the research, etc. (Read More)
9. NMPA Supports Hong Kong and Macao MAHs to Entrust Drug Manufacture to Companies in the Greater Bay Area
On June 29, NMPA notified the Guangdong Medical Products Administration to carry out the Plan to Support Pharmaceutical MAHs in Hong Kong / Macao to Manufacture Drugs in Nine Cities in the Greater Bay Area. The Plan sets conditions for the entrusting manufacture.
One condition is that the drugs should be TCMs or chemical drugs that are lawfully owned and manufactured by companies registered in Hong Kong or Macao, and with the Drug Registration Certificate issued by China NMPA. Drugs forbidden from entrustment are not covered by the Plan.
The other condition is that the entrusted manufacturers are required to have both the registered address and manufacturing site in the Greater Bay Area, and with Drug Manufacturing License covering the corresponding manufacturing scope or having passed the GMP compliance inspection. (Read More)
RELATED: China’s Marketing Authorization Holder System
10. NHC & NMPA Permits the Interim Import of Urgently-needed Drugs
On June 29, China National Healthcare Commission (NHC) announced the Work Plan for the Interim Import of Drugs Urgently Needed in Clinical Settings (hereafter referred to as the Interim Import Plan).
The Interim Import Plan applies to small amounts of overseas-marketed drugs that are not marketed but urgently needed in China. These drugs have no manufacturers in China, or the manufacturers in China cannot restore production in the short term.
The drugs with urgent clinical needs in small amounts refer to drugs in any of the following categories:
- (Orphan) Drugs for treating rare diseases;
- Drugs for preventing and treating diseases that pose severe danger to life and have no effective prophylactic or therapeutic drugs;
- Drugs for preventing and/or treating diseases and with clear clinical advantages. (Read More)
11. NMPA Information Center and CFDI Issues Guidance for Digital Records of Vaccine Manufacture & Tests
On June 23, NMPA’s Information Center and CFDI issued the Technical Guidance for the Digital Records of the Vaccine Manufacture and Tests with immediate effect. The Guidance specifies the digital record requirements for vaccine manufacturing and test processes, and lists the data items that should be recorded for devices, materials, operations, etc. (Read More)
12. NHSA to Adjust the 2022 National Reimbursement Drug List
On June 29, China National Healthcare Security Administration (NHSA) issued the Work Plan for Adjusting the 2022 National Reimbursement Drug List (NRDL). NRDL is a list of drugs covered by the basic national insurance for healthcare, employment injury, and maternity.
Pharmaceutical companies need to negotiate with NHSA to have their drugs stay in NRDL or bid for getting additional drugs into the NRDL. The adjusted 2022 NRDL is expected to be public in November this year and take effect at the beginning of 2023. (Read More)
13. Guidelines / Testing Methods / Standards
| No. | Guidelines / Testing Methods / Standards | Authority | Status | Release Date |
| 1 | Statistical Guidelines of Clinical Research on Rare Disease Drugs (Trial) | CDE | In force | June 6 |
| 2 | Technical Guidelines on the Design and Evaluation of the Taste of Pediatric Drugs | CDE | Draft | June 17 |
| 3 | Technical Guidelines on the Applicability of Single-arm Clinical Trials to Support the Marketing Authorization Applications for Anti-neoplastic Drugs | CDE | Draft | June 20 |
| 4 | Technical Guidelines on Clinical Research on New Drugs for Chronic Lymphocytic Leukemia | CDE | Draft | June 20 |
| 5 | Guidelines on Bioequivalence Studies of Tadalafil Tablets;
Guidelines on Bioequivalence Studies of Loratadine Tablets; Guidelines on Bioequivalence Studies of Tenofovir Alafenamide Fumarate Tablets |
CDE | Draft | June 22 |
| 6 | Technical Guidelines on Clinical Trial Plan Changes During the Ongoing Trial for Drugs (Trial) | CDE | In force | June 23 |
| 7 | Technical Guidelines on Clinical Research on Drugs for Type 2 Diabetes in Adults | CDE | Draft | June 27 |
| 8 | Technical Guidelines on Clinical Evaluation of In Vivo Therapeutic Radiopharmaceuticals | CDE | Draft | June 28 |
| 9 | Pharmaceutical Excipient Standards of Magnesium Trisilicate | ChP Commission | Draft | June 1 |
| 10 | Pharmaceutical Excipient Standards of Disodium Edetate | ChP Commission | Draft | June 1 |
| 11 | Pharmaceutical Excipient Standards of Aluminium Hydroxide | ChP Commission | Draft | June 1 |
| 12 | Pharmaceutical Excipient Standards of Powdered Cellulose | ChP Commission | Draft | June 1 |
| 13 | Chinese Pharmacopoeia Guidelines on Biological Evaluation and Selection of Tests for Pharmaceutical Packaging Materials | ChP Commission | Draft | June 10 |
| 14 | Chinese Pharmacopoeia Guidelines on Inspections of Pharmaceutical Packaging Materials | ChP Commission | Draft | June 16 |
| 15 | National Drug Standards of Rabies Vaccines (Hamster Kidney Cell) for Human Use | ChP Commission | Draft | June 21 |
| 16 | National Drug Standards of Rabies Vaccines (Vero Cell) for Human Use | ChP Commission | Draft | June 21 |
| 17 | Twelve Determination Methods for Glass Containers Used in Pharmaceutical Packaging:
4003 Determination of Internal Pressure of Glass Containers; 4017 Determination of Internal Pressure Resistance of Glass Containers; 4018 Determination of Break Strength of Glass Ampoules; 4019 Thermal Shock Resistance of Glass Containers and Determination of Thermal Shock Strength; 4020 Determination of Vertical Axis Deviation and Circular Runout of Glass Containers; 4021 Determination of Linear Thermal Expansion Coefficients of Glass; 4022 Determination of Average Linear Thermal Expansion Coefficients of Glass; 4023 Determination of Light-shielding Properties of Colored Glass Containers; 4024 Determination of Capacity of Glass Containers; 4201 Determination of Water Resistance of Glass Particles at 121℃; 4202 Determination of Water Resistance of Internal Surface of Glass Containers; 4203 Determination of Diboron Trioxide in Glass |
ChP Commission | Draft | June 28 |
| 18 | Six General Principles for Glass Containers:
5100 General Principles for Glass Containers Used in Pharmaceutical Packaging; 5101 General Principles for Glass Bottles for Infusion; 5102 General Principles for Glass Ampoules; 5103 General Principles for Glass Bottles for Injection; 5104 General Principles for Glass Components in Pencil Injectors; 5105 General Principles for Pharmaceutical Glass Bottles |
ChP Commission | Draft | June 28 |
Reprinted from: ChemLinked
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