The new guidance was issued, according to the SFDA, in order to improve the quality and level of drug research and development in China and continues China’s trend of integrating with international regulatory standards.

The new guidance: ‘Requirements on Application Dossiers in CTD Format for Pharmaceutical Products’ is based on the CTD of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH), in combination with the actual situation of drug research and development in China.

However, there is a caveat to this news as the SFDA still states as an addendum to the guidance that Attachment 2 of the ‘Provisions for Drug Registration’ SFDA Order No. 28 must still be referenced, meaning that NDAs must still use Attachment 2 as the primary guide.

The CTD has already been developed for Japan, the EU and the US through the ICH process, and India has also issued guidance for submissions in the CTD format.

The guidance document and Attachment 2 are available on the website of the SFDA.

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