- 2024,04,27
China's reform and opening up once again proves the enormous energy that can be unleashed by ideological liberation, and the slightly abstract concept of QbD, driven by the FDA, is also like a revolution in drug regulatory thinking.
In the words of Dr. Xu Jian, Director of the Pharmaceutical Administration Department of Jiangsu Hengrui Medicine, who is responsible for overseas registration, the international drug quality management standards have developed to a new stage. The Chinese pharmaceutical industry should adapt to the leap of international quality control concepts from "drug standard inspection control" to "cGMP production process control" to "R&D design control", including the determination of API synthesis process, workshop design, drug machine equipment development, preparation process research, etc, We must catch up and make up for shortcomings and gaps.
Yang Yingxin, the manager responsible for domestic and international drug registration at Zhejiang Xianju Xianle Pharmaceutical Co., Ltd., which is controlled by Far East Group and has years of experience in drug exports, also pointed out that the FDA's move is an improvement in regulatory philosophy. According to Yang Yingxin's analysis, the majority of domestic companies engaged in international business are still raw material pharmaceutical companies, and there are not many companies that truly export pharmaceutical preparations to the United States. Currently, the FDA has not directly set QbD requirements for raw material pharmaceuticals, but strengthens the management of raw material pharmaceuticals by strengthening the data review of generic pharmaceutical production enterprises. However, in the future, QbD will be implemented in the registration management of raw material pharmaceuticals.
Liu Chunguang introduced to reporters that in order to deepen the understanding of QbD among enterprises from various countries, the American Society of Pharmaceutical Scientists (AAPS) and the Chinese American Pharmaceutical Association (ACPA) will jointly hold the "FDA API Registration, Evaluation, and Technical Requirements Training Course" in Washington in May, aiming to provide participants with a comprehensive and systematic explanation of some of the latest important issues regarding the FDA's requirements for API and product quality. Experts from the FDA and relevant agencies in regulatory, registration, quality, and product development aspects will share their knowledge, experience, and forward-looking perspectives on these issues at the meeting. After the meeting, the delegation will also visit the FDA and relevant institutions. But according to Liu Chunguang's rough statistics, many of the companies he has contacted are still companies that have accumulated experience in international business in the past, and there are not many new faces, which makes him feel that the industry has not given enough attention to this.
Half of the profits come from the drug export business of Zhejiang Cheng Yi Pharmaceutical Co., Ltd. Ren Bingjun, the general manager, told reporters that Cheng Yi Pharmaceutical mainly cooperates with multinational companies to provide them with raw material drug supply. Despite the implementation of new management measures by the FDA, Cheng Yi Pharmaceutical's multinational partners already have good preliminary research and development and data information, which can meet the FDA's requirements, There is no need for enterprises to conduct research and solve problems.
For enterprises that attach great importance to international certification, Ren Bingjun believes that this is inevitably a good thing, just like the EU's new requirements for quality certification of imported raw materials, domestic pharmaceutical companies are also facing the same problem. And this new international drug quality management rule will be a major test for new enterprises entering the international trade field. They need more manpower and material resources to research the production of raw material drug DMFs, which meet international certification and archiving requirements. For new products, more deviation handling and quality traceability research are particularly needed. There must also be research results to support enterprises in interpreting and processing non pharmaceutical components such as drug residues, solvents, and degradation products. Of course, Ren Bingjun also believes that the internationalization of drugs and the application for international certification are not overnight achievements. However, with the decline in international raw material drug profits, the transformation towards higher value-added formulation exports is an inevitable choice for enterprises.
According to data, with the centralized expiration of a large number of original drug patents in recent years, the global market size of Generic drug has exceeded 50 billion dollars. There are also plans to support the export of pharmaceutical preparations in China. The "Industrial Transformation and Upgrading Plan (2011-2015)" issued by the State Council has put forward requirements for the pharmaceutical industry to seize the opportunity of rapid growth in the global generic drug market and prioritize the cultivation of new advantages in the international market. The Twelfth Five Year Plan for the Development of the Pharmaceutical Industry issued by the Ministry of Industry and Information Technology also proposes to speed up the pace of international certification of domestic drugs and realize the registration and sales of more than 200 Generic drug in developed countries such as Europe, the United States and Japan.