Regulatory Open Forum

Hi, folks,

Based on our years of drug registration experience of NMPA, and now we'd like to share the attentions during the registration, hope these information can be helpful. 

1. The dossier language must be Chinese and should submit together with the English version.

2. The RLD must be recognized by NMPA before the submission of ANDA.

3. Strongly recommend to held a agency communicate meeting to ensure the rationality of the Indication before the submission, to prevent the rejection.

4. The quality standards and test method should compare with ChP.

5. The PIL&label&artwork should comply the local requirements.

6. 6 months long-term stability data is mandatory for the agency acceptance.

7. The restricted part of the API dossier can be submitted to NMPA directly.

8. MA holder can be the overseas companies, but the local agent is mandatory.

9. Normally NMPA will ask the Chinese clinical trial data.(except the generic drug).

Thanks for your valuable information.

Has NMPA changed the review procedure from March 1^st  2024? Is it true that documents should firstly be checked by CDE's new validation software for digital formal examination, if it is passed then the documents will go into the next step for content formal check, if the content formal check is passed, then the information will be publicized on CDE platform?

Thank you.

Original Message:
Sent: 24-Mar-2024 22:45
From: Jennie Yang
Subject: The attentions of the drug registration of NMPA

Hi, folks,

Based on our years of drug registration experience of NMPA, and now we'd like to share the attentions during the registration, hope these information can be helpful. 

1. The dossier language must be Chinese and should submit together with the English version.

2. The RLD must be recognized by NMPA before the submission of ANDA.

3. Strongly recommend to held a agency communicate meeting to ensure the rationality of the Indication before the submission, to prevent the rejection.

4. The quality standards and test method should compare with ChP.

5. The PIL&label&artwork should comply the local requirements.

6. 6 months long-term stability data is mandatory for the agency acceptance.

7. The restricted part of the API dossier can be submitted to NMPA directly.

8. MA holder can be the overseas companies, but the local agent is mandatory.

9. Normally NMPA will ask the Chinese clinical trial data.(except the generic drug).

------------------------------
Jennie Yang
RA Director
Heaslicen Pharma Consulting
qiaolingyang89@163.com
Beijing, China
------------------------------