Drug registration management has undergone another significant change, with pharmaceutical technology now set to become a tradable product in the market. At a regular press conference held by the State Food and Drug Administration on September 8, Zhang Wei, director of the Drug Registration Department, announced that the administration recently issued the "Regulations on the Registration of Pharmaceutical Technology Transfers." This new policy marks the initial formation of China's drug registration management system and signals a new era focused on encouraging and guiding innovation.
One key question remains: can pharmaceutical technology achieve orderly circulation in the market? The newly issued regulations are part of four supporting documents under China’s broader Drug Registration Management Measures. For years, the industry has been waiting for clarity on technology transfer, and this regulation finally provides clear guidelines.
There have been notable changes in the number of approved documents, the level of specialization among pharmaceutical companies, technical thresholds, and the management of drug varieties. According to the new rules, once a pharmaceutical technology transfer is approved, the original approval number will be revoked.
Zhang Wei pointed out that in China, more than half of the approved drug numbers held by many manufacturers remain unused, and only a quarter of these are actually produced annually. This contradiction—where many approvals go unused while companies still seek new registrations—has led to inefficiencies and resource wastage.
The reasons for idle approvals vary, including fluctuating raw material prices and differences in market development capabilities. However, the accumulation of unused approvals has created numerous challenges for the industry. "The issuance of production technologies based on unused approval numbers not only wastes social resources but also hinders effective drug supervision, re-evaluation of marketed drugs, and adverse reaction monitoring," Zhang Wei explained. He emphasized that high-quality drug regulation must be built on normal production and sales.
Technology transfer allows companies to pass on unused production technologies to others who need them, promoting better resource allocation and fostering a healthier pharmaceutical industry. However, this isn't just about selling technology from one company to another. The process still requires new registration, and if the State Food and Drug Administration deems the risk too high, the transfer may not be approved.
In terms of quality control, the regulations have significantly raised the technical data requirements for both new drug technology transfers and production technology transfers. They emphasize technical comparisons before and after the transfer and add a review process. If the review determines that a clinical trial or bioequivalence test is needed, it must be completed.
Previously, such reviews and trials were not required for new drug technology transfers. According to Zhang Wei, this helps prevent simple transfers and encourages companies to reduce unnecessary dosage form changes and generic drug duplication, addressing the issue of low-level repetition at its root.
"The goal of this regulation is to treat technology as a product, enabling it to circulate in the market in an orderly manner and encouraging the conditional transfer of certain technologies," Zhang Wei said.
Some pharmaceutical companies have already begun adapting to these changes. The Shijiazhuang Group, for example, has been merging companies since last year, having completed three mergers so far. Niu Zhengqi, the group’s technical director, believes this regulation will guide the development of advantageous resources in the pharmaceutical industry.
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