Centre for Drug Evaluation (CDE): guidance policy document update

On July 2, the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) issued the initial draft of the policy document "Principles for Clinical Research and Development of Anti-tumour Drugs Guided by Clinical Value" whilst simultaneously inviting feedback from the life sciences sector.

The document emphasises that the purpose behind the research and development of new medicines should always be to provide patients with better options for treatment of diseases. Where clinical trials attain their predetermined targets, it is always prudent to review if sub-optimal methods of treatment were selected as a control. Such examples serve to highlight the fact that sub-optimal benchmark comparisons can adversely affect the true outcome of drug development and meeting the clinical needs of patients.

The inclusion of this principle in China’s domestic guidance policy document is in response to the 2017 U.S. Food and Drugs Administration’s (FDA) and 2020 International Technical Coordination Council for Drug Registration for Human Use’s (ICH) related clinical drug development guidelines. It will further improve the standardization of domestic clinical research in oncology drugs and establish a solid foundation for further alignment with the clinical standards of the developed nations. This guidance statement introduces stricter requirements for the development of me-too drugs with the same target or mechanism of action at a later stage of clinical development. This will also accentuate the true value of developing First-in-Class (FIC) and Best-in-Class (BIC) novel treatments.

It is postulated that the longer-term effect of such a guidance principle will be to encourage “true innovation” that produces tangible clinical value, reduce homogeneous competition, whilst improving the global competitiveness of China’s novel drug development sector.