The China National Drug Administration issued the Technical Guidelines for the Acceptance of Overseas Clinical Trial Data of drugs (hereinafter referred to as Guidelines) on 6 July 2018.
According to the Guidelines, overseas clinical trial data of drugs provided by the applicants may be accepted. Said overseas clinical trial data comprise those of innovative drugs which are developed both domestically and overseas and obtained overseas. In addition, for the generic drugs developed overseas, they can be registered in China if bioequivalent data thereof are complete and can be evaluated.
Overseas clinical trial data provided by applicants shall be true, complete, correct and traceable. The process of obtaining overseas clinical trial data shall comply with the Good Clinical Practice of China and the International Council for Harmonization (ICH).
The applicants shall ensure the completeness of clinical trial data. When the applicants intend to register drugs in China with overseas clinical trial data, they shall provide all the overseas clinical trial data.
The overseas clinical trial data that are submitted for drug registration in China shall comprise data concerning biopharmaceutics, clinical pharmacology, effectiveness and safety.
Upon a review, the China National Drug Administration may fully or partially accept the data or refuse the clinical trial data according to the quality of the same.
The Guidelines will provide substantial benefit to multi-national pharmaceutical companies, for example the considerably reduced cost of clinical trials in China and the significantly shortened registration timeline. Correspondingly, the patients in China will also get benefits from this new policy.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.