Strengthen the Regulation over Biological Products, Push Forward Sound and Rapid Development: the NMPA Held a Forum on Innovation and Development of Biological Products

  • 2018-11-12
On the afternoon of November 7th, the National Medical Products Administration (NMPA) organized a Forum centering on Innovation and Development of Biological Products to pool the suggestions from enterprise representatives, experts, scholars and industry associations in biological product circle from home and abroad, so as to gain a deeper understanding of the status quo and tendency of biological products across the world, objectively analyze the problems and challenges in regulation over biological products and commonly figure out how to perfect the regulation. Jiao Hong, the director of NMPA, attended the meeting and made a speech; Chen Shifei, the deputy director of NMPA, took the chair.

During the forum, participants held that NMPA shall firmly implement the requirements of CPC Central Committee and the State Council, vigorously carry out the Advice on Deepening Reform of Examination and Approval System and Encouraging Innovation in Drugs and Medical Devices issued by General Office of the CPC Central Committee and the General Office of the State Council (TZ [2017] No. 42) and consolidate the regulation over drug quality.

Jiao Hong concluded that biological products are undergoing great innovation, with new technologies keeping cropping up worldwide. The national drug regulatory authorities will conscientiously continue to carry out the reform of examination and approval system for drugs, endeavor to support the innovative development of biological products while maintaining the baseline of safety and, by doing so, to better meet the demand of the public.

Jiao emphasized that the regulators should combine supervision with services, enhance communication and exchanges with enterprises and industry associations, and carefully study and implement the opinions and suggestions proposed by the enterprises and industry associations. Profound policies and regulations are the results of scientific and democratic decisions made by the regulatory authorities, as well as the active involvement of enterprises and experts. Only in this way can the industry adapt to the national conditions of China and conform to international standards. As such, the drug regulatory policies will be more prospective to meet the requirements of industrial innovation and development. It is hoped that experts, scholars, industry associations and enterprises will devote themselves to the development of China's biological products industry by offering valuable ideas and suggestions. Meanwhile, all ministries and commissions should strengthen cooperation and make joint efforts to promote the sound development of the biological products industry.

Jiao also stressed that the enterprises should be the first persons responsible for ensuring product quality and safety. An enterprise which is responsible and innovative should meet relevant requirements from the design concept to the research and development process. Enterprises should fulfill their responsibilities in real earnest, improve the internal management system and strictly implement drug laws and regulations, drug quality standards and quality management practices. Additionally, enterprises should also constantly raise their awareness of product safety and social responsibility to protect public health in an effective manner.