Drug registration management has undergone another significant change, and pharmaceutical technology is now being positioned as a product that can circulate 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 the release of the "Regulations on the Registration of Pharmaceutical Technology Transfers." This new regulation marks the initial establishment of China's drug registration management system and signals a shift toward fostering innovation and guiding it in a more structured way.
The question remains: Can pharmaceutical technology achieve orderly circulation in the market? The newly issued regulations are one of four supporting documents under China's broader Drug Registration Management Measures. They provide clarity on a long-standing industry concern—technology transfer. There have been noticeable 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 regulation, once pharmaceutical technology is transferred and approved, the original approval number will be canceled. Zhang Wei pointed out that in China, more than half of the approved drug numbers held by many manufacturers remain unused, with only about a quarter of these actually being produced annually. This creates a paradox: while numerous approvals go unutilized, many companies still apply for new registration numbers.
Several factors contribute to this issue, including raw material costs and the market development capabilities of companies. However, the large number of idle approvals leads to various problems within the industry. "The issuance of production technology due to idle approval numbers not only wastes social resources but also hinders effective drug supervision, re-evaluation of listed drugs, and adverse reaction monitoring," Zhang Wei explained. High-quality drug supervision must be based on normal production and sales.
Technology transfer allows companies to pass on unused production technologies to others who need them, promoting optimal resource allocation and supporting the healthy growth of the pharmaceutical sector. However, this isn't just about selling technology from one company to another. The process requires new registration, and if the State Food and Drug Administration deems the risk of the transferred technology too high compared to its potential benefits, the transfer may not be approved.
In terms of quality control, the technical data required for both new drug technology transfers and production technology transfers have been significantly enhanced, drawing from the standards set for generic drugs. Emphasis is placed on comparing technical data before and after the transfer, and an additional review process has been introduced. If the review determines that clinical trials or bioequivalence testing are necessary, they must be completed.
Previously, new drug technology transfers did not require such reviews or clinical trials. In Zhang Wei’s view, this helps prevent simple transfers and encourages manufacturers to reduce unnecessary changes in dosage forms and generic drugs, ultimately addressing the issue of low-level duplication.
"The introduction of this regulation aims to treat technology as a product that can circulate in the market in an orderly manner, encouraging some technologies to be transferred under certain conditions," Zhang Wei said.
This change has already begun to influence some pharmaceutical companies. For example, the Shijiazhuang Group has been merging companies since last year, having completed three mergers so far. Niu Zhengqi, the group's technical director, stated that this regulation will guide the development of advantageous resources in the pharmaceutical industry.
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