China - NDA requirements update in 2024

1. NDA procedure

2. Related regulations/guidelines

Supportive guidelines for China CMC dossier preparation:

• M4Q: CTD for the Registration of Pharmaceuticals for Human use

• Regional guidelines:

  • Drug Registration Regulation (SAMR No. 27, 2020)

• Registration category and dossier requirement for Chemical drug; (NMPA No.44, 2020)

• Registration category and dossier requirement for Biologics; (NMPA No.43, 2020)

• Guideline on application check and acceptance for Chemical drug (NMPA No.10, 2020)

• Guideline on application check and acceptance for Biologics (NMPA No.11, 2020)

• CTD M4 Module 1 administrative documents (NMPA No.6, 2020)

• New registration category and dossier requirement for Chemical drug (NMPA No. 80, 2016)

3. Requirements for administrative documents (Module 1) - CMC related

• PPS (production procedure and specification) for biologics

• Manufacturing process information form for small molecules

• Proposed China registration specification (JX specification for chemical drugs and JS specification for biologics)

• On-site inspection related information

  • Drug Development Information Sheet

  • Drug Manufacturing Information Sheet

  • Site Master File

• Supporting documents of the product (if applicable)

  • Supporting documents for legal origin of active pharmaceutical ingredients, excipients and primary packaging materials, for examples, supply agreements, purchase order, or invoices, etc. (applicable to active pharmaceutical ingredients, excipients and primary packaging materials which are not registerred in CDE platform).

  • Letter of authorization for active pharmaceutical ingredients, excipients and primary packaging materials (applicable to active pharmaceutical ingredients, excipients and primary packaging materials which are already registerred in CDE platform).

4. Highlight for new requirement - Process validation

In the new Drug Registration Regulation (SAMR No. 27, 2020), completion of commercial-scale process validation prior to NDA submission is a new requirement.

Article 34 After having completed studies including CMC, pharmacological and toxicological studies and drug clinical trials supporting the drug marketing registration, established the specification and completed manufacturing process validation in commercial-scale and preparation for drug registration inspection and testing, the applicant can file a drug marketing authorization application...