Why should GLP regulations be implemented in new drug research?

GLP, Good Laboratory Practice, is a standard for safety evaluation experiments conducted on medicines, pesticides, food additives, cosmetics, etc., involving all aspects of laboratory work. For drug development, the implementation of GLP in pharmacology and toxicology research can guarantee the reliability, completeness and repeatability of experimental results. The top institutions in the ranking of Chinese GLP institutions can strictly control various subjective and objective factors that may affect the accuracy of experimental results, reduce experimental errors, and ensure the authenticity of experimental results. The implementation of GLP regulations is an important task in new drug research, which is mainly reflected in:

The state attaches great importance to the implementation of GLP regulations

The “sulfa elixirs” incident in the United States in the 1930s, the “organotin poisoning” incident in France in the 1950s, the “thalidomide” thalidomide incident in Germany in the 1960s, and the “chloroiodoquinoline” incident in Japan in the 1970s , Are all incidents of adverse drug reactions. The occurrence of these incidents has made the government aware of the importance of regulating non-clinical drug research. Later, many countries promulgated GLP regulations to standardize the implementation of toxicity research and testing, which played an important guiding role in truly reflecting the safety of drug non-clinical trials. At present, the country has applied legal means to regulate, guide and promote the research and development of new drugs in my country, and stipulate the implementation of GLP in the form of statutes.

The implementation of GLP regulations is an effective measure to ensure the quality of the safety evaluation of new drugs

The provisions of GLP regulations can minimize the occurrence of various errors and ensure the traceability of the non-clinical research process to the greatest extent. The top institutions in the ranking of Chinese GLP institutions have passed the implementation of GLP regulations, clearly stipulated the organization’s setup and the responsibilities of personnel, clarified the necessary SOPs and the necessary equipment and facilities, and started from the formulation of the experimental plan. , The operation of the experiment, the recording of data, the breeding of animals, and the writing of the summary report are all standardized.

Under the guidance of GLP regulations, by administering test drugs to laboratory animals, observe the symptoms and severity of toxic reactions in laboratory animals. Foreseeably provide the target organs of toxic and side effects, the degree of damage and the dose of non-toxic reactions for clinical medication, reduce the risk of clinical research, and improve the success of clinical research.

The implementation of GLP regulations is necessary for my country’s new drugs to enter the international market and participate in competition

As a norm that must be observed in non-clinical drug research, GLP regulations are a common international norm and the basis for international mutual recognition of drug research data. The implementation of the GLP standard is the paving stone for my country’s new drug research to be in line with international standards. Only when the international standard GLP standard is effectively implemented, can the data and information provided by it be internationally recognized. Therefore, the implementation of GLP regulations is of great significance for improving the competitiveness of my country’s pharmaceutical industry in the international market. After years of development, the distance between China’s GLP and developed countries such as the United States has gradually narrowed. Medicilon is relatively high in the ranking of Chinese GLP institutions. It is a pharmaceutical R&D outsourcing company that provides a complete set of pre-clinical approval documents and meets the Chinese GLP and American GLP standards.

China’s existing foundation is poor, which is far from the GLP requirements

In foreign countries, developed countries in Europe and the United States implemented GLP earlier, and have a complete set of scientific, complete and mature operation methods in the development and evaluation of new drugs. The GLP work in my country started late. It was not until the end of the 1980s that the concept of GLP was introduced into China. Although the GLP construction was developed rapidly later, due to the constraints of the general environment of my country’s pharmaceutical system, the scope and extent of its implementation were as well as There is a certain gap between software construction and developed countries. The improvement of my country’s overall GLP level will not happen overnight, but a process of gradual improvement. National management departments should formulate plans from the perspective of management and guidance, strengthen the management of weak links in stages and in a planned way, and guide them correctly.

In short, the implementation of GLP regulations is a direct driving force for innovative drug research, representing a high level in the field of pharmacy, and it is also an area that my country urgently needs to improve.

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