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).
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Jennie Yang
RA Director
Heaslicen Pharma Consulting
qiaolingyang89@163.comBeijing, China
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