On October 13, more than 180 people from the antibody vaccine research and development industry gathered in the Chengdu Hall of Shanghai Hope Hotel. Ten teachers from the antibody-drug research and development industry and scientific research institutes also brought wonderful sharing.
Starting from the concept and use of antibodies, Dr. Zhang Aihua discussed the classification and nomenclature of antibody drugs. Taking CD47 as an example, Dr. Zhang expounded on the mechanism of action and clinical application of antibody drugs. At present, the research and development of monoclonal antibodies are very hot. In the process of development, we should distinguish the differences between the development of innovative antibodies and the quality control of Biosimilar. In the development of innovative drugs, adequate quality research should be carried out in accordance with the development concept of quality originating from design (QbD) and the principle of being safe, being effective, and having controllable quality.
Dr. Wang Gang, the chief scientist, was responsible for compliance and inspection at the CFDA Drug Review Center (CDE). He introduced the framework of the State Drug Administration of China, which is the three-tier legal system of the laws, regulations, and technical guidelines of the State Drug Administration. He also introduced the procedures for the registration and approval of China’s Biological Products Licensing Application (BLA) and New Drug Application (NDA). He affirmed that the reform of administration, law, and drug approval procedures of the State Drug Administration will greatly promote the development of new drugs in China, and compares the management review system of the Food and Drug Administration of Europe and the United States. At last, he showed his perspectives toward the future reform of China’s pharmaceutical regulatory system. Dr. Wang has led us to review the specific regulation of the amendments to the Drug Administration Law of the People’s Republic of China and to the Regulations on Drug Registration and Administration, and their far-reaching impact on the pharmaceutical R&D industry in recent years.
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