Britain is changing its approach to drug approvals. The country’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to make greater use of clinical trial data from China in order to speed up market access for new drugs, GxP News reports. The move contrasts with the US position, which has tightened requirements for Chinese studies due to concerns over data quality and representativeness. The British regulator does not plan to universally accept Chinese data but aims to develop a clear strategy by the end of 2026.
The shift is driven by the rapid growth of pharmaceutical research in China, where thousands of new molecules enter clinical trials each year, GxP News notes. Global companies, including AstraZeneca, are actively investing in Chinese science parks, while Western biotech firms are competing for rights to promising Chinese drug candidates.
“Western countries can no longer afford to reject Chinese data, otherwise they will cut themselves off from the most innovative drugs,” MHRA chief executive Lawrence Tallon said.
Regulators worldwide have traditionally been sceptical of Chinese studies due to questions over quality and whether results apply to other populations, GxP News explains. However, there are already examples of successful acceptance. The European Medicines Agency has recommended, and the MHRA has approved, the lung cancer drug serplulimab based on studies conducted primarily in China.
The main challenge for the MHRA is learning to distinguish high-quality Chinese studies from poor ones, but Tallon is confident this can be solved, GxP News reports. Large pharmaceutical companies have already mastered this process, actively buying molecules from Chinese biotechs and scaling up production overseas. The British regulator sees its role as systematising this approach so as not to shut itself off from breakthrough innovations.
The new strategy is also intended to boost Britain’s attractiveness as a drug-launch market following Brexit, which led to staff cuts at the MHRA and trial delays, GxP News notes. The regulator plans to seek recognition of its approvals in other countries, compensating for the limited size of the domestic market.
Earlier, Bloomberg Opinion noted that the pharmaceutical industry has become bipolar, centred around the United States and China, GxP News concludes. As the publication’s columnist observed, China has not only narrowed the gap in research output but in some cases has pulled ahead in developing new treatment methods.
