Why Conduct Clinical Trials in China? A Regulatory Perspective

The ongoing pandemic has changed the landscape of clinical development in prominent ways. Conducting clinical trials in China is advantageous from regulatory perspective because ten months is the usual duration for the China State Food and Drug Administration (SFDA) to approve clinical trial applications (1). Regulatory reform in China has enhanced clinical trial review and approval. Specifically, an updated investigational new drug (IND) review procedure was created in China by 2019 which have favorable implications on trial efficiency (2). First, applicants may carry out drug clinical trials within 60 days of the application date and payment as long as the applicant has not received any rejection or query opinions from the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (2). Also, applicants only need to complete three steps to carry out an IND upon elimination of needing to submit an application to the provincial FDA (2). The three steps consist of a pre-IND meeting, submission of the filing to the CDE, and the CDE’s review and approval (2). Also, the likely time period for regulatory approval of clinical trial applications are now shortened from 265 days to 65 days (2). The average review timeline now comes out to 40 workdays (2). With industry wide acceptance of overseas data, applicants can avoid repetitive studies, register more efficiently, retain longer market exclusivity, and enable patients to receive innovative therapies as soon as possible (2). China’s regulatory procedures have been streamlined for market access by harmonizing drug development and clinical trials execution as well as joining hands with the International Council for Harmonization (ICH) (3). In addition, the Chinese Centre for Drug Evaluation (CDE) has increased their number of drug reviewers, which has reduced review timelines and increased the number of approvals. Therefore, China has created a regional framework that encourages R&D of new drugs in line with global standards (3).  

Source Links

1.     Chinas Regulatory Reforms – Promoting Pharma Innovations (pharmafocusasia.com)

2.     Regulatory reform in China enhancing clinical trials review and approval – Cortellis (clarivate.com)  

3.     China and the evolving regulatory landscape (europeanpharmaceuticalreview.com)

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