China: Optimization of Registration Application for Transferring Overseas-Produced Drugs into Domestic Production

As part of the initiative to boost foreign investments in the pharmaceutical industry and improve high-quality drug developments and accessibility to China’s market, the National Medical Products Administration (NMPA) issued a notice with optimization measures for transferring overseas-produced drugs that have been marketed in China to domestic production.

Highlights of the notice are as follows:

• Domestic applicants must submit an application according to the requirements and procedures for drug marketing registration application if the drug is produced overseas but domestically marketed being transferred to domestic production.

• For transferring conditions as above, the applicant may submit the original registration materials together with additional research materials as supportive documents for the drug marketing registration application.

• NMPA has included the drug registration application transfer of original chemical drugs and biological products to domestic production in their review and approval processes’ priority.

Applicants are required to submit the marketing registration application as a generic drug, during the transfer process from overseas to domestic production. The simplified requirements applications only exist if the production process, raw materials, prescriptions, and packaging materials are similar to abroad production.

Source: National Medical Products Administration (NMPA)

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