On 8th October 2017, the last day of China’s Gold Week holiday, the General Office of the CPC Central Committee and the General Office of the State Council issued “The Opinions on Deepening the Reform of Review and Approval Systems to Encourage Innovation of Drugs and Medical Devices”. On an expanded basis, this document is the official outcome of the CFDA’s draft regulation series on drugs and medical devices.
The opinions were composed of six major themes, each including several points with 36 points altogether. Acurit Medical Communications has previously published an article focused on themes one and two below.
The six major themes are:
- Reform clinical trials management, to ensure that clinical trials are scientific, normative and authentic;
- Expedite marketing review and approval of drugs and medical devices that are in urgent need clinically, to meet public medication demands;
- Promote medicines innovation and generic drugs development, to propel the healthy growth of China’s pharmaceutical industry;
- Fully implement the Marketing Authorisation Holder system, and strengthen lifecycle management of drugs and medical devices;
- Enhance technical support capability to serve innovation to the fullest;
- Strengthen organisation and implementation for this policy to be put into effect via rule of law and rule by law.
The goal is that this guideline will stimulate the vitality of pharmaceutical research and development, improve innovation, and address the shortage issues of drugs and medical devices in need clinically, so that patients can access life-saving medications as soon as possible. For next steps, relevant government agencies will organise the implementation, develop detailed supporting documents, and monitor outcomes.
We hope a smooth and successful implementation of this most important policy in the history of China’s pharmaceutical industry since the foundation of the People’s Republic of China.
Sources in Chinese: