Update: China CDE Updates eCTD Structure for Drug Registration Applications
On Jan. 1, 2023, China National Medical Products Administration (NMPA) started to require that all documents for drug registration applications, as well as supplemental documents sent during the review, shall be submitted electronically in compact disks with no paper.1
Before this, only some documents, e.g., the application form, were required to be submitted in compact disks while other documents were required in paper. Now all documents should be stored in compact disks.
The application documents should be organized in the following structure2:
Application Type | Folder | Documents | |
Clinical trial application and marketing authorization application for chemical drug and biological product | Application info | Application form, self-review form, commitment letter, etc. | |
Module 1 (M1) Administrative documents and drug info | M1: Administrative documents and drug info | ||
M2 CTD summary | M2: CTD summary | ||
M3 Quality | M3: Quality | ||
M4 Non-clinical research report | M4: Non-clinical research report | ||
M5 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. | |
1 Administrative documents and drug info | 1. Administrative documents and drug info | ||
2 Summary | 2. Summary | ||
3 CMC (chemistry, manufacturing, and control) research documents | 3. CMC research documents | ||
4 Pharmacology & toxicology research documents | 4. Pharmacology & toxicology research documents | ||
5 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. |
1 Summary | 1. Summary | ||
2 CMC research documents | 2. CMC research documents | ||
3 In vitro evaluation | 3. In vitro evaluation | ||
4 In vivo evaluation | 4. In vivo evaluation | ||
Injection | Application info | Application form, self-review form, commitment letter, etc. | |
1 Summary | 1. Summary | ||
2 CMC research documents | 2. CMC research documents | ||
3 Non-clinical research documents | 3. Non-clinical research documents | ||
4 Clinical trial documents | 4. Clinical trial documents | ||
Supplemental application | TCM | Application info | Application form, self-review form, commitment letter, etc. |
1 Drug approval certificate documents | 1. Copies of drug registration certificate and its appendices | ||
2 Certification documents | 2. Certification documents | ||
3 Inspection-related info | 3. Inspection-related info | ||
4 Project aim and basis | 4. Project aim and basis | ||
5 Medication package insert | 5. Draft of the revised medication package insert and detailed revision notes | ||
6 Drug label | 6. Draft of the revised drug label and detailed revision notes | ||
7 CMC research documents | 7. CMC research documents | ||
8 Pharmacology & toxicology documents | 8. Pharmacology & toxicology research documents | ||
9 Clinical research documents | 9. Clinical research documents | ||
10 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. | |
1 Drug approval certificate documents | 1. Copies of drug approval certificate and its appendices | ||
2 Certification documents | 2. Certification documents | ||
3 Info related to inspections and tests | 3. Info related to inspections and tests | ||
4 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. | ||
5 CMC research documents | 5. CMC research documents | ||
6 Pharmacology & toxicology research documents | 6. Pharmacology & toxicology research documents | ||
7 Clinical research documents | 7. Clinical research documents | ||
8 Others | 8. Other documents required by NMPA | ||
Change of marketing authorization holder (MAH) | Application info | Application form, self-review form, commitment letter, etc. | |
1 Drug approval certificate documents | 1. Copies of drug registration certificate, etc. | ||
2 Certification documents | 2. Certification documents | ||
3 Applicant’s commitment | 3. Applicant’s commitment | ||
4 Others | 4. Others | ||
Registration renewal application for drug manufactured overseas | Application info | Application info: application form, self-review form, commitment letter, etc. | |
1 Certification documents | 1. Certification documents | ||
2 Summary of import and sales info | 2. Summary report on the import and sales in China during the last five years | ||
3 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 | ||
4 Researches | 4. Researches required to be completed in time according to the drug approval certificate documents and NMPA | ||
5 Manufacturing process, quality standards, etc. | 5. Drug formulation, manufacturing process, quality standards, testing methods, packaging materials and containers in direct contact with the drug | ||
6 API supplier info | 6. Supplier of the active pharmaceutical ingredient (API) used in the finished drug product | ||
7 Medication package insert and drug label in use | 7. Medication package insert, inner label, and outer label used in the Chinese market | ||
8 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 | |
1 CMC research documents | / | ||
2 Pharmacology & toxicology research documents | / | ||
3 Clinical research documents | / | ||
The electronic acceptance letter, as valid as the paper version, will be sent to the applicant via "Drug Service Application System" and "Drug eCTD Registration System".
From Dec. 29, 2021, China started to permit applicants of Class 1/5.1 chemical drugs and class 1 prophylactic/therapeutic biological products to submit application documents in eCTD format. If choosing eCTD format, applicants should refer to the Announcement on Adopting Drug eCTD Format and no longer need to submit paper documents either.
Related:
- Draft Regulations for Electronic Submission of Drug Registration Applications
