Update: This article only covers the draft regulations. Please refer to the updated report for China's electronic submission requirements which took effect on Jan. 1, 2023.
On Nov. 4, China National Medical Products Administration (NMPA) released a series of draft regulations on electronic drug registration application, requiring application dossiers to be submitted in compact discs instead of paper.1 Public advice and comments are welcomed to be sent to zhongwch@cde.org.cn before Nov. 20, 2022.
The draft regulations include:
1. Announcement on Electronic Drug Registration Applications
2. Announcement on the Requirements for Electronic Drug Registration Applications
3. Technical Requirements for Compact Discs Containing Application Dossiers
4. Document Structure of Electronic Drug Registration Applications
5. Commitment Letter
Compact Disc Submission
According to Draft 1 Announcement on Electronic Drug Registration Applications, drug registration applications as well as supplemental documents during the review shall be submitted in compact discs from Dec. 1, 2022. For applications submitted in paper before Dec. 1, 2022, supplemental documents submitted during the review can still be in paper. The submission process stays the same as before.
For drug applications submitted in Electronic Common Technical Documents (eCTD) format, the paper documents, previously required by the Announcement on Adopting the eCTD Submission for Drug Registration Applications, will no longer be required. Other requirements in the announcement will still be effective.
Format Review of the Application Dossiers
Draft 2 Announcement on the Requirements for Electronic Drug Registration Applications notes that Center for Drug Evaluation (CDE) will review the application dossier's format within 5 workdays upon receiving the compact discs.
If the application is accepted, CDE will upload the acceptance letter to the "Drug Affair Application System" and the "Drug eCTD Registration System". The applicants will be reminded through SMS and can download the letter directly. CDE will NOT send the acceptance letter to the applicant in paper.
For applications that need supplemental documents or are rejected, CDE will destroy the compact discs containing the application dossiers instead of sending them back to the applicants. Therefore, applicants need to keep a copy of the application dossiers.
Technical Requirements for Dossiers
Draft 3 Technical Requirements for Compact Discs Containing Application Dossiers mandates that application documents shall be submitted in PDF format and all the contents in the documents shall be copyable and searchable. For font style and page layout, applicants shall refer to the Standards of Format, Style, Collection of Drug Registration Application Dossiers.
Application Dossier Structure
Draft 4 Document Structure of Electronic Drug Registration Applications stipulates that the documents shall be organized as shown in the table below.
Application Type | Folder Name | Contained Documents | |
Clinical trial application and marketing authorization application for chemical drug and biological product | Application info | Application form, self-review form, commitment letter, etc. | |
Administrative documents and drug info | Module 1 (M1): Administrative documents and drug info | ||
CTD summary | M2: CTD summary | ||
Quality | M3: Quality | ||
Non-clinical research report | M4: Non-clinical research report | ||
Clinical research report | M5: Clinical research report | ||
Clinical trial application and marketing authorization application for traditional Chinese medicine (TCM) | Application info | Application form, self-review form, commitment letter, etc. | |
Administrative documents and drug info | 1. Administrative documents and drug info | ||
Summary | 2. Summary | ||
CMC (chemistry, manufacturing, and control) research documents | 3. CMC research documents | ||
Pharmacology & toxicology research documents | 4. Pharmacology & toxicology research documents | ||
Clinical research documents | 5. Clinical research documents | ||
Quality and therapeutic equivalence evaluation of chemical generics | Oral solid dosage form | Application info | Application form, self-review form, commitment letter, etc. |
Summary | 1. Summary | ||
CMC research documents | 2. CMC research documents | ||
In vitro evaluation | 3. In vitro evaluation | ||
In vivo evaluation | 4. In vivo evaluation | ||
Injection | Application info | Application form, self-review form, commitment letter, etc. | |
Summary | 1. Summary | ||
CMC research documents | 2. CMC research documents | ||
Non-clinical research documents | 3. Non-clinical research documents | ||
Clinical trial documents | 4. Clinical trial documents | ||
Supplemental application | TCM | Application info | Application form, self-review form, commitment letter, etc. |
Drug approval certificate documents | 1. Copies of drug registration certificate and its appendices | ||
Certification documents | 2. Certification documents | ||
Inspection-related info | 3. Inspection-related info | ||
Project aim and basis | 4. Project aim and basis | ||
Medication package insert | 5. Draft of the revised medication package insert and detailed revision notes | ||
Drug label | 6. Draft of the revised drug label and detailed revision notes | ||
CMC research documents | 7. CMC research documents | ||
Pharmacology & toxicology documents | 8. Pharmacology & toxicology research documents | ||
Clinical research documents | 9. Clinical research documents | ||
Review of product safety documents | 10. Review of product safety documents | ||
Chemical drugs / biological product | Application info | Application form, self-review form, commitment letter, etc. | |
Drug approval certificate documents | 1. Copies of drug approval certificate and its appendices | ||
Certification documents | 2. Certification documents | ||
Info related to inspections and tests | 3. Info related to inspections and tests | ||
Quality standards, medication package inserts, etc. | 4. For chemical drugs: drafts of revised drug quality standards, manufacturing process info form, medication package insert, and label, as well as detailed revision notes. For biological products: drafts of revised drug quality standards, manufacturing process, medication package insert, and label, as well as detailed revision notes. | ||
CMC research documents | 5. CMC research documents | ||
Pharmacology & toxicology research documents | 6. Pharmacology & toxicology research documents | ||
Clinical research documents | 7. Clinical research documents | ||
Others | 8. Other documents required by NMPA | ||
Change of marketing authorization holder (MAH) | Application info | Application form, self-review form, commitment letter, etc. | |
Drug approval certificate documents | 1. Copies of drug registration certificate, etc. | ||
Certification documents | 2. Certification documents | ||
Applicant's commitment | 3. Applicant's commitment | ||
Others | 4. Others | ||
Registration renewal application for drug manufactured overseas | Application info | Application info: application form, self-review form, commitment letter, etc. | |
Certification documents | 1. Certification documents | ||
Summary of import and sales info | 2. Summary report on the import and sales in China during the last five years | ||
Summary of clinical use and adverse drug reactions (ADRs) | 3. Summary report on the clinical use and ADRs of the drug imported to and sold in China during the last five years | ||
Researches | 4. Researches required to be completed in time according to the drug approval certificate documents and NMPA | ||
Manufacturing process, quality standards, etc. | 5. Drug formulation, manufacturing process, quality standards, testing methods, packaging materials and containers in direct contact with the drug | ||
API supplier info | 6. Supplier of the active pharmaceutical ingredient (API) used in the finished drug product | ||
Medication package insert and drug label in use | 7. Medication package insert, inner label, and outer label used in the Chinese market | ||
Specification about overseas approval | 8. Specification and Chinese translation of the approval certificate granted by the overseas drug regulator | ||
One-time import | Application info | Application form, commitment letter, etc. | |
Application dossiers | Please refer to Appendix 2 of NMPA's Announcement on Drug Registration Renewal | ||
Documents (supplemental documents, stability research documents, etc.) submitted during the review | Certification documents | Including commitment letter | |
CMC research documents | / | ||
Pharmacology & toxicology research documents | / | ||
Clinical research documents | / | ||
If you need the details of the drafts or have other questions about drug registration in China, please contact BaiPharm for professional answers and solutions.
China Starts to Issue Electronic Drug Registration Certificates
