Li Li stresses NMPA's mission of ensuring drug safety and effectiveness
Li Li, Secretary of the NMPA Leading Party Group, emphasized acting on the people-centered philosophy of development and ensuring drug safety and effectiveness during an inspection in Suzhou, Jiangsu province between June 17 and June 20.
Li Li, Secretary of the NMPA Leading Party Group, stressed drug safety during Suzhou inspection.
During the inspection, Li visited the administrators at the market regulation bureaus of Suzhou and Huqiu district as well as a branch in the town of Dongzhu. He also came to the Suzhou branch of the Jiangsu Institute of Medical Device Testing， the Suzhou Institute for Drug Control and the Center for Drug Complaints&Reports to look into the development of the local drug regulatory team and the local regulatory system by communicating with front-line staff.
Li visited pharmaceutical manufacturers, large pharmaceutical chain companies, retail pharmacies and community healthcare institutions, randomly checked some drug manufacturing and distribution enterprises, and investigated drug quality management, new drug R&D and innovation, and management of licensed pharmacists and vaccination procedures.
He urged that enterprises should effectively enhance their sense of responsibility and innovation, strengthen quality management and innovation in research and development, fulfill their responsibilities in ensuring drug safety, and improve their core competitiveness. Symposiums with regulatory authorities and with pharmaceutical enterprises, experts and scholars were held to collect more opinions and suggestions.
After listening to a report on drug regulation in Jiangsu province, Li praised such practices as the establishment of regional inspection agencies, the consolidation of front-line working forces, and innovation in drug regulation.
He pointed out that drug safety concerns public health and there is zero tolerance for negligence. Drug regulators should put the "four strictest" benchmarks into practice, bear their responsibilities in mind and elevate people’s sense of security, gain and happiness.
Li highlighted the regulatory work in five aspects.
First, strictly control drug risks. Drug regulators should promote the implementation of the responsibilities of enterprises, regulators and local administrators, establish a long-term mechanism to investigate and resolve potential safety hazards, properly resolve historical issues, actively respond to new risks and new challenges, and effectively nip risks in the bud.
Second, support high-quality drug development. Drug regulators should deepen reform of the review and approval system, support the R&D and innovation of enterprises, accelerate the marketing of new drugs and drugs proven to be effective, and promote China’s transition towards a pharmaceutical power house.
Third, improve the drug regulatory system and mechanism. Drug regulators should mull the regulatory powers of each link, strengthen vertical and horizontal coordination, and form a uniform and coordinated working mechanism.
Fourth, consolidate the basic capabilities of drug regulation. Drug regulators should enhance the laws and regulations for drug administration, push the cultivation of professional drug inspectors, and vigorously develop regulatory science and smart supervision.
Fifth, build a clean regulatory system. Drug regulators should strengthen discipline education and anti-corruption mechanisms and continuously meet people's new requirements and new expectations in drug regulation.
Directors from relevant NMPA departments participated in the inspection.