New regulations for medical device supervision and administration will be released

The head of the National Medical Products Administration, Jiao Hong, stated at the China Pharmaceutical Innovation Development Conference:“Actively promote the newly revised "Pharmaceutical Administration Law" and theMedical DeviceSupervision and Management Regulations" to be issued this year, accelerate the revision and formulation of supporting regulations, provide legal and institutional guarantees for the early implementation of various reform measures, and release policy benefits.”

Recently, the China Pharmaceutical Innovation Development Conference opened in Jinan, and Jiao Hong, director of the National Medical Products Administration, attended the conference and delivered a speech.

Jiao Hong pointed out that after 40 years of reform and opening updevelopment, China's public drug use has been basically met, the level of drug security has continued to improve, and it has actively contributed to the global effort. Currently, a wave of innovation in the domestic pharmaceutical industry continues to rise, and the good atmosphere in which all sectors of society support, care about, and participate in reform is becoming increasingly strong. The trend of the entire industry attaching importance to innovation and taking the initiative to innovate is becoming increasingly apparent. It has become a consensus among party committees and governments at all levels, various departments, and the industry to pursue high-quality development of the pharmaceutical industry. The policy environment encouraging innovation in pharmaceuticals and medical devices is gradually improving, and a number of innovative pharmaceutical achievements have emerged, demonstrating China's capabilities and level in pharmaceutical innovation.

Jiao Hong said that strong supervision creates a strong industry, and a strong industry promotes strong supervision. Regulatory work and industrial development promote each other. Grasping innovation is to promote development, and grasping innovation is to plan for the long term. Stimulating the vitality of innovation and development in the pharmaceutical industry, promoting the transformation and upgrading of the pharmaceutical industry, and better meeting the public's needs for medicine are also the inherent meaning of building a healthy China.

Jiao Hong emphasized that encouraging innovation is the inescapable responsibility of the drug regulatory authorities, and will continue to do a good job in various aspects. First, further improve the legal and regulatory system. Actively promote the newly revised "Pharmaceutical Administration Law" and the "Medical Device Supervision and Management Regulations" to be issued within the year, accelerate the revision and formulation of supporting regulations, provide legal and institutional guarantees for the early implementation of various reform measures, and release policy benefits.

Second, further deepen the reform of the review and approval system. Guided by clinical value, improve the priority review and approval procedures, accelerate the review and approval of innovative and urgently needed drugs and medical devices, support the research and development of drugs for rare diseases, support the inheritance and innovation of traditional Chinese medicine, and fully promote the consistency evaluation of the quality and efficacy of generic drugs.

Third, further strengthen post-market supervision.Strictly implement the four "strict" requirements, urge the holders of marketing authorizations to fulfill their main responsibilities, strengthen the management of the entire product life cycle, accelerate the construction of a professionalized inspection team, severely crack down on illegal and irregular behaviors, and create a good environment for industrial development.

Fourth, further promote regulatory science research. Fully implement the China Drug Regulatory Science Action Plan, systematically carry out basic research on drug regulatory science, actively promote the research of key regulatory science projects, and improve the scientific level of drug regulation.

Fifth, further serve the innovative R&D of pharmaceutical enterprises.Continuously deepen the reform of "delegating power, streamlining administration, and improving services", earnestly listen to the voices of enterprises, actively and enthusiastically provide services to enterprises, communicate frankly and sincerely with enterprises, and help enterprises develop in a practical way; timely formulate and adjust regulatory policies to guide the adjustment of industrial structure, so that innovators are encouraged and rewarded, and strive to promote China's transition from a major pharmaceutical country to a strong pharmaceutical country.