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Opportunities and Challenges of FDA's Domestic Pharmaceutical Supervision International Cooperation
"XXX pharmaceutical company? Here is the US FDA office in China. We plan to conduct an on-site inspection of your company's pharmaceutical production facilities exported to the United States. Please contact us." The next day after the announcement, the US FDA office in China and third-party certification Several persons from the organization appeared at the company’s production site.
It may not be long before this situation mentioned above will become a reality that our country's pharmaceutical exporters must attach great importance to and face. Prior to this, FDA audits, COS certifications, and other on-site inspections conducted by the U.S. Food and Drug Administration (FDA) and the European Drug Quality Steering Committee (EDQM) on Chinese pharmaceutical companies were often due to visa, negotiation, confirmation, and other reasons. There is a relatively long interval between the issuance of the notification and the verification, and the pharmaceutical companies are relatively well prepared.
All of this stems from the implementation of three US office plans by the US Food and Drug Administration in Beijing, Guangzhou and Shanghai. According to reports, on November 19, the US FDA office in China was officially unveiled in Beijing. This is the first office set up by the FDA in the United States. The FDA will also open offices in India and Latin America next month. The relevant departments in China will also set up a food safety accreditation regulatory agency in the United States. The FDA's decision to invest this “first†in China is a true reflection of the increasing trade volume in China and the United States, the rapid development momentum, and the deepening cooperation between the two countries.
It should be said that the initiation of international cooperation in drug regulation is in line with the economic globalization situation and is in line with the general trend of the world's pharmaceutical industry to accelerate the transfer to developing countries such as China and India. Just as SFDA Director Shao Mingli stated at the opening ceremony, with the development of economic globalization, drug safety issues have already crossed national borders. Safeguarding public drug safety and life and health is a historical mission placed before governments of all countries. Only strengthened cooperation is the only one. select. The author believes that the United States, with its advanced technology, strict standards, comprehensive mechanisms, and modern scientific management experience, has the advantage that we need to learn from it in terms of drug production and safety, quality assurance systems and testing, and market supervision.
The initiation of international cooperation in drug supervision will undoubtedly improve the level of pharmaceutical production and supervision in China, in particular, accelerate the implementation of cGMP and promote the sound and rapid development of China's pharmaceutical production. Some media claimed that “this gap has led to a 'cooperative' approach that looks like equality and actually expropriates rights in return for the international community’s trust in China’s foodâ€. This view is inevitably short-sighted and ignores the continuous improvement of China’s pharmaceutical development and pharmaceutical supervision. Achievements. Not to mention that this kind of cooperation is based on the equality and mutual trust between the two sides, and may be carried out in a manner that relies on the certification or inspection of third-party independent organizations. Cooperation itself is also a powerful promotion for latecomers.
According to the U.S. interpretation, as part of the FDA's internationalization, the US FDA office in China is responsible for inspecting the relevant export food and drug production facilities, providing guidance on U.S. quality standards, and assisting the host country in carrying out relevant testing capabilities. It is the ultimate establishment of a global network management system to replace the current border customs inspection. For Chinese pharmaceutical companies, it indicates that under the new drug safety situation, while new forms and in-depth supervision of international cooperation are on the agenda, more flexible, more frequent and more targeted foreign certifications, audits, Inspections will become the norm in future pharmaceutical production. In the short term, it is a test for China's pharmaceutical companies, and pharmaceutical companies should change their concepts, strictly regulate GMP production, improve efficiency and rapid response capabilities, and accelerate the move toward cGMP. In the long run, pharmaceutical companies have received FDA certification in earlier design, production, and other links. The strengthening of understanding and cooperation among regulatory authorities helps eliminate foreign customers' doubts about the quality of Chinese manufacturing and promote the development of pharmaceutical products in China to a broader international market. .