Great thank you for that input Hamish. I have looked a little into this also but I am wondering if you are aware of any specific M1 or regional documents that are needed for phase 1?
I have looked and found some information more towards NDAs but it would appear that some of the same information is being requested in phase 1 including batch records?
Original Message:
Sent: 18-Jan-2022 01:44
From: Hamish King
Subject: Chinese CTA - CMC documentation requirements
Orla
In response to your queries:
Yes. In the Nonclinical Overview section (Nonclinical Overview), you can list summarised information about completed nonclinical studies according to the format and content of ICH CTD 2.4. See the requirements on Page 14.
For module 2.3 quality summary, we do not believe that ICH CTD M2.3 is required at the clinical application stage, because there are pharmacological studies that have not yet occurred at this stage. However, the NMPA requirement for this section is similar to ICH CTD M2.3, but the description content has been simplified. See the details on Page 6-9 for chemical drug, and Page 9-13 for Biological Products.
As an example of chemical drug, Pharmacology information required by NMPA is summarized below.
1.1 New drug substances Information | 1.2 Formulation drugs Information | 1.3 Placebo Information |
1.1.1 Manufacturer | 1.2.1 Formulation & product composition | If the clinical trial protocol requires the use of placebo, information & research studies of placebo should be provided, such as the prescription, manufacturing process and relevant information of the manufacturing plant, quality control, test results etc. |
1.1.2 Manufacturing Process | 1.2.2 Name & add. of Manufacturer |
1.1.3 Identification & verification of Structure | 1.2.3 Manufacturing Process |
1.1.4 Physical and chemical properties | 1.2.4 Quality control |
1.1.5 Quality control | 1.2.5 Stability |
1.1.6 Stability | 1.2.6 Package and storage condition |
1.1.7 Package and storage condition | 1.2.7 Others |
The above is of course only of general application and may be different for your specific circumstances.
Kind regards,
Hamish
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Hamish King
hamish.king@cisema.com
www.cisema.com
Original Message:
Sent: 12-Jan-2022 15:41
From: Orla Finneran
Subject: Chinese CTA - CMC documentation requirements
Hi Hamish ,
Can I ask you is it your understanding that it 2.4 for which a summary in line with ICH is required.
I have been asked to provide a module 2.3 quality summary but I think that some or a lot of this information is placed in the annex to the application form?
The technical guide does state a summary of the quality information should be provided but it is more explicit as I read that the non-clinical and maybe the clinical summary 2.4 and 2.5 (maybe dependent on your stage in trials globally) is provided.
I can't translate the link you have kindly provided so cannot see if it is included there.
kind regards,
Orla
------------------------------
Orla Finneran
Ireland
Original Message:
Sent: 11-Jan-2022 19:55
From: Hamish King
Subject: Chinese CTA - CMC documentation requirements
Anon,
Yes, the list for China is more extensive than other markets. And summaries are required in the IMPD for IND/CTA application in China for Phase 1-3.
To expand on this, NMPA requirements for new drug Phase I clinical trial application documents are as follows：
- Introduction description and general research plan
- Researcher handbook
- Clinical trial protocols
- Pharmaceutical development information
- Pharmacological and toxicological information
- Description of previous clinical use experience
- Overseas research materials
For (5) pharmacological and toxicological information, NMPA requires applicants to provide:
- Summary of non-clinical studies
- Summary of pharmacological studies
- Summary of toxicological studies
- Summary of pharmacokinetics
Final version of each summary study report (the toxicology study summary report can be delayed within 120 days after the clinical trial application).
The NMPA requires that the part of "Summary of non-clinical studies" be presented in accordance with the format and content of ICH CTD 2.4.
For reference, see page 14 of the annex to this link, where it states that Summary of non-clinical studies can refer to the format and content of ICH CTD 2.4: https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20180125135801903.html
------------------------------
Hamish King
Hong Kong
hamish.king@cisema.com
Original Message:
Sent: 06-Jan-2022 09:25
From: Anonymous Member
Subject: Chinese CTA - CMC documentation requirements
This message was posted by a user wishing to remain anonymous
Dear colleagues,
I am reaching out within the community for some wisdom/practical experience with IND/CTA requirements in China.
This market is reasonably new but exciting to me for but requires some navigation and better understanding from me- there are differences in what is being requested to support CTA's in China for Phase 1-3. The list for CN is much more extensive to other markets including US and EU. Almost to the level of a MA/NDA submission.
We are being asked for M2 summaries to support phase 1-3 trials. Do others have experience in providing or not on this request. looking at the translated guidance/regulations received it is not clear that the summaries are required in the IMPD.
I would appreciate any input or learnings that you can share.
Thank you in advance