No More Papers—China to Require Compact Disc Submission for All Drug Registration Applications

by Grace Wang Nov 10, 2022

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.

Related: China Starts to Accept eCTD Format for Marketing Authorization Applications for Specific Classes of Drugs;

China Starts to Issue Electronic Drug Registration Certificates

Grace Wang
ChemLinked Regulatory Analyst
+ FOLLOW
Copyright: unless otherwise stated all contents of this website are ©2022 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact cleditor@chemlinked.com