Drug registration in China – transferring overseas production to China made easier

Drug registration in China for pharmaceuticals initially manufactured abroad to now register as domestically produced drugs has been made easier by the National Medical Device Administration (NMPA). The NMPA issued a notice on April 23, 2024, which indicates broader efforts to enhance the foreign investment environment and promote high-quality development in the domestic pharmaceutical industry. The key points from the notice are:

1. Applications for the domestic production of drugs that are currently manufactured abroad and marketed in China must be made by domestic applicants following the standard drug registration application requirements and procedures.
2. Applicants can use the original registration materials of the foreign-produced drugs but they must provide additional research data related to the transfer to domestic production to support their registration application. The specific requirements for application materials were released by Center for Drug Evaluation (CDE) on May 9, 2024, however we cover the main requirements below.
3. The NMPA has included the applications to transfer registration of original chemical drugs and biological products to domestic production in its priority review and approval process.

Detailed registration application material requirements for transferring chemical drug registrations from produced abroad to Made-in-China status

General Requirements

1. Application for Marketing Registration:
   • When transferring production of marketed drugs from overseas to domestic, applicants must submit a marketing registration application as a generic drug.
   • Use the Common Technical Document (CTD) format and indicate the transfer explicitly in the application form, including the drug approval number.
2. Simplification for Imported Innovative Drugs (Class 5.1):
   • Simplified requirements for application materials exist if the production process, prescription, control of raw materials, and packaging materials are consistent with those used abroad.
   • Applicants must conduct corresponding research if there are changes following relevant technical guidelines and clearly indicate exempted or simplified information with reasons.

Module-specific Requirements

• Module 1: Administrative and Product Information:
  • Provide approval documents for the overseas drug, quality standards, production process, and other relevant information.
  • Include notarized consent from the transferor for domestic production.
  • Different specifications of the same drug should be transferred to the same domestic applicant.
• Module 2: Overview and Quality Summary:
  • Summarize the quality comparison before and after the transfer.
  • Document any changes beyond the licensee and production site, indicating simplified or omitted studies where applicable.
• Module 3: Quality Data:
  • Prescription and process research must show consistency with the overseas production.
  • Provide detailed production and quality control information.
  • Conduct comprehensive quality comparison studies on multiple batches before and after the transfer.
  • Stability studies include 6-month accelerated tests and long-term stability investigations.
• Module 4: Non-clinical Study Reports:
  • For non-oral preparations, provide safety test data comparing pre- and post-transfer samples.
  • If necessary, conduct additional non-clinical bridging studies.
• Module 5: Clinical Study Reports:
  • Generally, in vivo research is not required if pharmaceutical comparability is demonstrated.
  • For drugs that cannot be proved consistent through pharmaceutical studies, consider undertaking bioequivalence (BE) studies.

Additional Simplification Criteria

1. For drugs transferred within the same head office, further simplification is allowed if no changes in the production process, prescription, raw materials, or packaging occur.
2. Simplified registration criteria for generic drugs include self-testing of 1-3 batches and stability studies on 1-3 batches.

Special Considerations

1. Innovator Drugs with Conditional Approval:
   • Generally not allowed to transfer to domestic production.
   • Only routinely approved indications can be declared for domestic production.
2. Reference Preparations:
   • Requirements for reference preparations at the time of acceptance must be consistent with generic drug registration.
3. Number of Transfers:
   • Drugs cannot be transferred multiple times to different domestic holders.
4. Narcotic and Psychotropic Substances:
   • Follow current requirements for generic drug declaration and marketing.
5. Inclusion in Chemical Drug Catalogue:
   • Drugs meeting technology transfer requirements can be included in the catalogue following procedures.
6. Imported Generic Drugs:
   • Please note that these must be declared according to current generic drug listing requirements without simplified application materials.
7. Simplified Procedures:
   • Only for class 5.1 imported new drugs, simplified documentation requirements are permissible. Among them, for cases where overseas produced drugs that have already been listed are transferred to domestic holders (and manufacturers) of the same parent company, if there is no change in technology before and after the transfer, the application materials are the most simplified.

These are the detailed registration application material requirements for transferring chemical drug registrations from overseas to “Made-in-China”. This regulation is intended to streamline China localization and foster manufacturing of pharmaceutical products in China.

Further information

Read the original NMPA announcement on Drug registration in China – transferring overseas production to China made easier.

Read our previous article on Changes during the China drug registration – Working procedures implemented.

Contact us today to learn more about our drug and drug master file registration services.

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