NMPA studied the revised Pharmaceutical Administration Law and also deployed the work on drug safety supervision during the National Day
NMPA studied the revised new Pharmaceutical Administration Law and also deployed the work on drug safety supervision during the National Day On September 6, the Leading Party Group of National Medical Product Administration (NMPA) held a meeting to study the revised Pharmaceutical Administration Law of People’s Republic of China and to deploy the work on drug safety supervision during the National Day festival.
XU Anbiao, Deputy Head of Legislative Affairs Commission of NPC Standing Committee was invited to give a lecture. LI Li, Chief of the NMPA Leading Party Group presided over the meeting and delivered remarks. Xu debriefed on the background, process and general requirements of the revised Pharmaceutical Administration Law, systematically explained the general principle of the revision and important systematic innovation, and specifically interpreted the license holder system for the listed drugs, drug research and evaluation approval, drug production, storage and supply, drug operation and price control, drug use and risk control as well as supervision and law enforcement. The proposal of next-step promotion and publicity work was also offered.
According to Li, both the Pharmaceutical Administration Law and the Vaccine Administration Law were key legal basis for the medical product regulators in their supervision and fulfillment of functions and responsibilities. At present and in the future, it is part of major work for NMPA to advance the promotion and publicity of the two laws. Meanwhile, the formulation and revision of supporting regulations and files about two laws should be accelerated to improve the system of relevant technical guidelines, instruct the provincial authorities in improving the local supporting system and ensure the smooth implementation of the laws. Also, it is required to deepen the reform of evaluation and approval system about drugs, further enhance the communication and consultancy mechanisms, optimize the procedure of evaluation and approval, encourage the R&D and innovation of drugs and accelerate the steps of new and good drugs to get listed.
Besides, the competent authorities are required to enhance law enforcement in drug supervision, reinforce the supervisory and extended examination, handle the illegal or offensive acts in accordance with the law and put every individual accountable under punishment. They should enhance the capacity building in regulation, promote the team building of professional drug inspectors and the institutional building of regulation technology, and improve the capabilities of evaluation and approval, verification and examination as well as the surveillance and evaluation, so as to advance the modernization of drug regulation system and capabilities.
(Source: NMPA website)