Regulations on the Safety of Biotechnology Research and Development (Draft for Comments)

On March 11, the Ministry of Science and Technology issued the Regulations on the Safety of Biotechnology Research and Development (Draft for Comments) to manage biotechnology research and development activities in a hierarchical manner.
" the development of modern molecular biology and synthetic biology, it is possible to genetically modify organisms. Yuan Zhiming, a member of the National Committee of the Chinese People's Political Consultative Conference (CPPCC) and president of the Wuhan branch of the Chinese Academy of Sciences, said that foreign scientists had synthesized the 1918 Spanish flu virus, and some scientists had recombined and mutated different viruses, which eventually changed the host scope and transmission of the virus, which pushed the relevant laws to control biotechnology from the DNA operational level.

with the occurrence of gene-edited infants, the scope of regulations from the DNA operational level to the control of biological characteristics, the timing of the time.
explicitly support, not limit" the attitude of the Regulations on the Safety of Biotechnology Research and Development (Draft for Comments) is very clear, supports biotechnology research and development, establishes a biotechnology innovation system, increases research input, and promotes the development of biotechnology innovation..." Yuan Zhiming said, the regulation was formulated on this tone, the state supports the development of biotechnology, the new regulations are issued to better support research activities that are beneficial to humanbeing, not to limit the development of biotechnology research.
similar classification management systems have long been in place in the field of pathogenic pathogens. Yuan Zhiming,
, said, for example, the Biosecurity Regulations of the Pathogen Microbiology Laboratory divide pathogenic microorganisms into four categories according to the infectious nature of pathogenic microorganisms and the degree of harm to individuals or groups after infection.
have similar classification regulations on the safety of genetically modified organisms in agriculture.
", "it is necessary to classify and manage scientific research and technology development activities carried out using biotechnology."
," Yuan Zhiming said. Yang Linhua, a representative of the National People's Congress of
and director of the hematology department of Shanxi Medical University's Second Hospital, agreed that biotechnology-related research activities need to be strictly managed to provide a safe environment for the development of biotechnology.
classification management is more complex, and experts use biotechnology to carry out activities involving the technology itself and the target of application.
, for example, the same gene editing technique, acts on reproductive and somatic cells, and the safety level should be different. Yuan Zhiming,
, said that a detailed and reasonable risk assessment system could be developed in a variety of ways.
" newly published Regulations on the Safety of Biotechnology Research and Development (Draft for Comments) are a large framework that is not segmented, but there should be a risk list that clearly delineates the risks of biotechnology.
" Yuan Zhiming's speculation was confirmed by the China Biotechnology Development Research Center, a participant in the regulation-making, and the person in charge told science and technology daily that the list of risks would be drawn up separately.
" materials, exgenous genes, implementation techniques, etc. need to be taken into account.
" Yuan Zhiming said, for example, two viruses with a low risk level may become high-risk viruses if recombined, and may not change, but there will be a basic principle of judgment. "Biotechnological research and development activities are classified as high, general and low risk, depending on the actual and potential risk levels,"
the Regulations on the Safety of Biotechnology Research and Development (Draft for Comments).
exact assessment method sat in the open.
" is more difficult to define and must be clearly written in the Ordinance.
" Yang Linhua said, biotechnology categories, the implementation of a complex object, is a heavy workload, the difficulty of judging the research process.
this is a new subject. Yuan Zhiming,
, said that the relevant factors can be determined weighting or the formation of calculation methods such as detailed evaluation methods, and in practice further adjusted.
the need to strengthen regulation and simplify access procedures In the Regulations on the Safety of Biotechnology Research and Development (Draft for Comments), the subject responsible for regulation is the Biosafety Commission. "This is not a new thing, it is the 'standard' of pathogenic pathogen research and genetically modified organisms research units,"
.
, " said Yuan Zhiming, who is responsible for assessing biosecurity.
But for many other research units, the Biosafety Commission is still a "new thing".
newly released documents, the committee needs to be established to file, in addition to risk assessment, but also to develop risk reduction plans, regular follow-up checks, tracking the dynamic changes in risk.
"The question now is how the new regulations will be linked to the previous regulations, " he said.
" Yuan Zhiming said, for the relevant research units, if the convergence is not good, will bring long, duplicate supervision.
representatives said that if the implementation of the existing regulations, for a single medical research project, it is likely to go through the Health and Care Commission, the Ministry of Science and Technology, the Drug Administration and other multi-departmental supervision, "sawing war" will reduce the enthusiasm of researchers to research.
", "wants to enhance interdepartmental communication and strengthen regulation while simplifying access procedures."
" Source: Science Daily.