Editor's Notes: Monthly recap is a collection of recent pharmaceutical laws, regulations, and policies in China, 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.
1. Work Procedures for Expediting Marketing Approval of Innovative Drugs
On Feb. 22, 2022, China Center for Drug Evaluation (CDE) released its Work Procedures for Expediting the Review of Marketing Applications of Innovative Drugs (Trial) for public comments. The Work Procedures says that for marketing authorization applications of innovative drugs with Breakthrough Therapy Designation, the technical review will be completed within 130 workdays.1 [Read More]
2. Guidance for Acceptance Review of Filing Documents of Chemical APIs
On Feb. 9, CDE started to solicit public opinions on the draft of Guidance for Acceptance Review of Active Pharmaceutical Ingredients (API) of Chemical Drugs. The Guidance applies to the marketing authorization applications of chemical APIs. Applicants are required to file documents, including patent information and production license, to CDE. Applicants of foreign chemical APIs should entrust a domestic agent in China to file the documents.2
RELATED: DMF Filing for APIs, Excipients, and Packaging Materials in China
3. Guidance for Acceptance Review of Registration Applications of TCMs, Chemical Drugs, and Biological Products
On Feb. 18, CDE announced its consultation draft of Guidance for Acceptance Review of Registration Applications of Traditional Chinese Medicines, Chemical Drugs, and Biological Products (Trial). The Guidance lists the documents required for the clinical trial and marketing authorization applications of drug products.
For foreign applicant who entrusts a Chinese corporate agent with registration, the applicant should include the following documents into the drug application: the entrustment document, the notarization document and its Chinese translation, as well as a copy of the agent's business license.3
4. The 51st Batch of Reference Listed Drugs
On Feb. 11, NMPA released the 51st list of reference listed drugs (RLD), including 45 drugs such as Pfizer's Acipimox Capsules and Daiichi Sankyo's Pravastatin Sodium Tablets.4 The RLDs are selected by NMPA as reference products for generic drugs. For all RLDs recognized in China, please visit BaiPharm Database.
5. Random Inspections of Medical Devices
On Feb. 22, NMPA published the 2022 Plan for Random Inspection of Medical Devices. The Plan specifies the inspection standards for medical devices. If a medical device holder dissents from the conclusion given by the inspection report, the holder can request a re-inspection from the provincial medical products administration within seven workdays from receiving the report. A re-inspection can only be carried out once for the same inspection report.5
6. 208 Newly-approved Medical Devices
On Feb. 18, NMPA revealed the list of 208 medical devices approved in January this year. 54 of the devices are imported from foreign countries and regions, such as Königsee Implantate GmbH's Gliding Nail and DePuy (Ireland)'s ATTUNE Revision Cementless Sleeves.6
7. Guidelines for Pharmaceutical Industry
No. | Guideline | Authority | Release |
1 | Writing Guidelines for Technical Requirements of Medical Devices | NMPA | Feb. 9 |
2 | Q&A on "Formulation Ratio Similarity" as a Pharmacological Evaluation Criterion for Exempting Bioequivalence Studies of Generics with Different Strengths from the Reference Listed Drugs (Trial). *The "similarity in formulation ratio" is mentioned in the Technical Guidelines for Human Bioequivalence Studies on Generic Drugs with Pharmacokinetic Parameters as a Terminal Evaluation Criterion. | CDE | Feb. 10 |
3 | Technical Guidelines for Clinical Pharmacological Research on Biosimilars | CDE | Feb. 11 |
4 | Technical Guidelines for Clinical Trials of New Antiviral Drugs for COVID-19 Pneumonia (Trial) | CDE | Feb. 17 |
5 | CDE | Feb. 18 | |
6 | CDE | Feb. 18 | |
8 | CDE | Feb. 22 | |
9 | Technical Guidelines for Clinical Trials of Human Fibrinogen (Trial) | CDE | Feb. 25 |
10 | Technical Guidelines for Clinical Studies on Rabies Vaccines for Human Use (Trial) | CDE | Feb. 25 |
