Monthly Recap: China Pharmaceutical Regulatory Updates | June 2022

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:

1. The accepted, reviewed, and approved drug applications;

2. The expedited approvals;

3. Onsite inspections;

4. Approved medical products in significant therapeutic areas;

5. Disapproval reasons;

6. Reforms of the drug review & approval system.

ChemLinked BaiPharm members can download the report for free at BaiPharm Insight.

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.

On June 21, CDE released the Work Procedures for the Application and Administration of Communication on Pediatric Drugs for public comments. The Work Procedures applies to pediatric drugs in any of the following categories:

1. Drugs in the List of Pediatric Drugs Encouraged for R&D and Registration Application;

2. 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.

3. Class 1 innovator drugs or class 2 improved drugs specially developed for children, including chemical drugs, prophylactic biological products, and therapeutic biological products.

4. 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.

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. Find out more details at BaiPharm News.

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. Find out more details at BaiPharm News.

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.

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.  

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.

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.

RELATED: China's Marketing Authorization Holder System

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:

1. (Orphan) Drugs for treating rare diseases;

2. Drugs for preventing and treating diseases that pose severe danger to life and have no effective prophylactic or therapeutic drugs;

3. Drugs for preventing and/or treating diseases and with clear clinical advantages. 

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.