On May 9, China CDE released the Dossier Requirements for Marketing Authorization Applications of Approved Imported (Chemical) Drugs to Be Transferred to Domestic Production.
According to the regulation, when transferring approved imported drugs to domestic production, the domestic applicant is required to submit a marketing authorization application following the guidelines for chemical generic drugs. The application should be prepared and submitted in accordance with the current version of the "M4: Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use," using the specified CTD format and sequence of sections. A clear statement indicating the transfer of approved imported drugs to domestic production, along with the corresponding drug approval number, must be included in the special declaration section.
However, imported original drugs is allowed to follow simplified documentation requirements. When using this approach for marketing authorization applications to transfer production domestically, it is advisable to maintain consistency in the production process, composition of the prescription, control of APIs and excipients, and packaging materials that directly come into contact with the drug. In the event of any changes, it is necessary to conduct corresponding research and provide supportive study data in accordance with the relevant technical guidelines.
It should be noted that transferring approved imported drugs to different holders for domestic production multiple times is not permissible.
Contact BaiPharm if you need more details of the simplified documentation requirements in China.
