The influence of China's joining PIC/S on drug manufacturers

On June 19, 2017, China joined ICH (International Technical Coordination Committee for the Registration of Human Drugs). Since September 2018, negotiations with PIC/S headquarters began, and after 7 rounds, finally on September 24, 2021, the State Food and Drug Administration sent a letter to start the pre-application process to join PIC/S, steadily promoting the pace of regulatory internationalization. On June 28, 2022, the State Food and Drug Administration held a meeting of the Leading Group Office of the Drug Inspection Cooperation Program (PIC/S) to review the progress of the work related to joining PIC/S. At present, China is carrying out the standardization work of GMP and addendum with PIC/S GMP and Addendum. The next step will be to complete the gap analysis report, formulate the standard revision plan, and further improve the updating mechanism of China's pharmaceutical GMP standards.

The inspection standards of the International Pharmaceutical Certification Cooperation Organization have become the gold standard and the international standard for the inspection of the international pharmaceutical Manufacturing practice (GMP), and some countries in the world have reached an inspection mutual recognition agreement based on PIC/S inspection standards. China's entry into the International Drug Certification Cooperation Organization and learning from international management experience will help improve China's drug GMP standards, improve China's GMP inspection system, promote the construction of drug inspectors, strengthen international inspection exchanges and cooperation, and promote the high-quality development of China's drug supervision. It is an important path for China's drug inspection to be in line with international standards and an important basis for international mutual recognition in the future.

On June 16, 2023, the International Pharmaceutical Certification Cooperation Organization (PIC/S) notified the latest work progress of the China National Food and Drug Administration's application to join the organization, and China has completed the pre-application stage, and plans to formally apply for membership this year. Joining PIC/S is significant for regulators and the pharmaceutical industry as a whole. It is mainly manifested in the following aspects:

First, it can improve the production and quality management level of the entire Chinese pharmaceutical enterprises.

It is understood that two years after joining PIC/S in Japan, the proportion of C and D grade pharmaceutical companies dropped from 50% in 2014-2015 to 32% in 2016. During the preparation period for applying to join PIC/S, the domestic pharmaceutical industry will experience the reshaping of the entire GMP and inspection system, and the GMP concept will run through the whole process of drug production, which requires high capital requirements and hard power requirements for enterprises. Although pharmaceutical companies have made great progress in research and development, clinical, production and many other aspects in recent years, at this stage, China's pharmaceutical companies are scattered and the number is large, and the overall GMP compliance is still uneven.

Second, it is also very important to improve the quality of China's overall drug supervision team, especially the on-site inspection of regulators, "to have an international competition enterprise, there must be an international regulatory body."

This is the future trend of supervision, that is, scientific supervision, efficient supervision and intelligent supervision, so from a more far-reaching sense, China's enhancement of regulatory capacity and the internationalization of pharmaceutical companies must be carried out simultaneously, and the internationalization of regulatory ability has a great help to the internationalization of pharmaceutical companies.

Third, due to the mutual recognition between the various members of the PIC/S organization, it will greatly shorten the time to market, save costs for enterprises, accelerate the export of products, and reduce regulatory pressure.

Whether it is joining ICH or PIC/S, the FDA will push the mutual recognition of research and development level to the mutual recognition of production, although ICH also includes production, but the focus of the two organizations is different, ICH focuses on safety, effectiveness and quality control guidance, while PIC/S focuses on inspection.

Our country to formally join the PIC/S organization application, for our enterprise challenges and opportunities coexist, difficulties and hopes. In the face of opportunities and challenges, we should accurately identify changes, respond scientifically, take the initiative to change, actively assume the responsibility for enterprise quality, and lead the direction of enterprise quality development. Establish goals, grasp core tasks, firmly seize opportunities, actively respond to changes, persist in learning, innovation and improvement, organize enterprise GMP experts and related professionals to study PIC/S regulations on the standard, form gap analysis reports, formulate standard revision plans, and upgrade and system transformation from both software and hardware aspects according to the plans. Continuously improve the quality supervision ability, and continuously improve the GMP implementation level. With the help of the company's excellent performance, total quality management, GMP experts and other resources, quickly improve the quality management level, and achieve the goal of the first-class level of production quality management industry as soon as possible.