Focusing on scientific and technological innovation to creat

2022-05-20 11:07

Focusing on scientific and technological innovation to create a new situation in the work of key laboratories, the State Food and Drug Administration held a meeting on work exchange and promotion of key laboratories

Xu Jinghe pointed out that to do a good job in the construction of key laboratories is the need to accelerate the leap from a big pharmaceutical country to a powerful pharmaceutical country, the need to accelerate the modernization of drug regulatory system and regulatory capacity, the need to accelerate the implementation of China's drug regulatory scientific action plan, the need to accelerate the high-quality development of drug regulatory cause, and the need to deeply understand and do a good job in key experiments It is of great significance to accelerate the construction of key drug laboratories.

At the meeting, representatives from five laboratories spoke. The Key Laboratory for quality research and evaluation of biological products is one of the first batch of key laboratories of the State Food and drug administration. Novel coronavirus pneumonia vaccines have been built in recent years, and a number of vaccines, immunotherapy and stem cell preparations have been established to provide adequate technical reserves for the fight against new crown pneumonia. In the near future, it plans to apply for the State Key Laboratory.

Sichuan key laboratory is one of the first batch of biomedical materials testing center. By undertaking the research projects related to the scientific action plan for drug regulation in China, we have achieved a breakthrough in the regulatory technology system of new biodegradable devices from scratch, and solved the technical problems of safety regulation of new biodegradable devices.

The Key Laboratory of cosmetics monitoring and evaluation is based on Shanghai Institute for food and drug control. Over the past year, it has been an important force in the construction of cosmetic technology support system to participate in 19 items of formulation and revision of cosmetic standards, undertake 16 items of cosmetic risk monitoring tasks, participate in safety risk assessment, and explore the establishment of risk substance database of some raw materials.

The Key Laboratory for research and evaluation of generic drugs is composed of Beijing Institute for drug control, State Pharmacopoeia Commission and Institute of pharmacy, Chinese Academy of Medical Sciences. Over the past year, 81 research projects have been carried out around generic drugs, helping to select reference preparations, actively providing technical services for consistency evaluation to enterprises, and forming a generic drug development joint force linking prescription process development, in vivo and in vitro evaluation, supervision and industrial application.

The Key Laboratory of research and evaluation of traditional Chinese medicine is one of the second batch of newly established key laboratories based on the construction of Beijing University of traditional Chinese medicine. The laboratory aims to build a new drug evaluation system of traditional Chinese medicine in line with the characteristics of traditional Chinese medicine, build a toxicity research platform of traditional Chinese medicine, build a post marketing clinical re evaluation research mechanism platform, and strive to improve the scientific, standardized and international level of traditional Chinese medicine.

In recent years, the provincial drug regulatory authorities have actively participated in the construction of key laboratories of the State Food and drug administration, and achieved remarkable results in several aspects. According to the introduction of Guangdong Provincial Drug Administration, the province has always focused on promoting scientific and technological innovation and developing supervision science, forming a good atmosphere for scientific and technological innovation and scientific research cooperation. At present, a total of 17 key laboratories of the State Food and drug administration have settled in Guangdong, ranking the first in the country, providing a strong driving force for the development of the pharmaceutical industry in Guangdong Province.

Xu Jinghe fully affirmed the achievements of the key laboratory and put forward two requirements for the construction of the key laboratory in the next step. First, key laboratories should do a good job in "two services" and continuously improve their own ability. First, we must adhere to the innovation of the service pharmaceutical industry, and actively participate in and support the innovation of pharmaceutical enterprises and develop more innovative products, in accordance with the requirements of general secretary Xi Jinping's "four Orientals", while increasing basic research and applied research. Two, we must adhere to the needs of service drug supervision, actively participate in the supervision of scientific research, and innovate a number of regulatory tools, standards and methods. Efforts to speed up the launch of products and improve the quality of supervision. Second, the regulatory authorities should do a good job in service and management, and promote the efficient operation of the system. It is necessary to scientifically plan the construction layout of key laboratories and clarify the development direction and tasks. It is necessary to strengthen management evaluation, actively support the operation and development of key laboratories, establish dynamic adjustment mechanism, and timely carry out supervision and inspection and dynamic evaluation.

The meeting was held online and offline. The relevant persons in charge of the relevant business departments and bureaus of the State Food and Drug Administration and the personnel of the construction and Management Office of the key laboratories of the State Food and Drug Administration attended the meeting in the main venue. The relevant persons in charge of the provincial drug regulatory departments, the directors of the first and second batch of key laboratories and the main persons in charge of the supporting units attended the meeting in each branch venue.