The Eleventh Session of the Standing Committee of the 13th National People's Congress passed the Vaccine Administration Law of the People's Republic of China on June 29. On the same day, the general office of the NPC Standing Committee held a press conference on the new law, at which, Jiao Hong, Commissioner of the National Medical Products Administration (NMPA), answered questions from the media.
Jiao said the new law will implement a rigorous whole-process supervision system to ensure the safety, effectiveness and accessibility of vaccines and raise public confidence in vaccine safety.
According to Jiao, vaccine is a special type of drugs because it concerns national strategy and public welfare. The law, in accordance with the characteristics of vaccines, puts forward "the most rigorous administration system", covering the whole process of development, production, distribution and vaccination. It also specifies heavier penalties, compared with other drugs, for the production and sale of fake or substandard vaccines, including penalties on qualification, property and personal freedom.
In addition to safety, the Vaccine Administration Law also aims to stimulate development and innovation, stressed Jiao. In order to elevate the quality of vaccines, a series of new regulations has been put forward to encourage innovation and development.
Firstly, the State will support fundamental and applied research on vaccines, promote vaccine development and innovation, and incorporate the development, production and stockpile of vaccines for serious diseases into national strategies.
Secondly, the State will stipulate vaccine industry development plans and industry policies, encourage larger-scale and intensive vaccine production, and constantly improve the production process and quality of vaccines.
Thirdly, the State will support the development of new types of combination vaccines and multivalent vaccines by formulating development plans and providing funds based on epidemiological and immunological studies. Efforts will be made to ensure that market authorization holders, research institutions and medical institutions are strongly positioned to develop vaccines in urgent need.
Fourthly, the State will encourage heavier investment in development and innovation from marketing authorization holders to optimize the production process and improve quality control levels. Furthermore, innovative vaccines will be eligible for priority review and approval.
Jiao also pointed out that the vaccine industry has seen rapid growth since the founding of the People's Republic of China, especially since the reform and opening-up. China is now one of the few countries that can supply all the vaccines in the immunization program through its own resources.
China's vaccine regulatory system passed the World Health Organization assessments in 2011 and 2014, and is preparing for a new round of evaluation. Issuance of the Vaccine Administration Law will be a good opportunity for China to improve the national regulatory system for drugs and vaccines, push forward the vaccine industry, ensure drug safety for the public and realize its transition to a vaccine power house.
Yuan Lin, director general of the Department of Drug Regulation of the NMPA, Yuan Jie, director of administrative law at the NPC Standing Committee's Legislative Affairs Commission, and Cui Gang, associate counselor for the Bureau of Disease Prevention and Control of the National Health Commission participated in the press conference and answered questions on the electronic vaccine tracking system, legal responsibilities, vaccination, and issues of vaccination safety respectively.
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