(Yicai) May 18 -- The Hong Kong Center for the Medical Products Regulation, the special administrative region's independent drug regulator set to launch by the end of this year, will allow Chinese mainland innovative drugmakers submit applications for local market while applying for registration with the National Medical Products Administration, likely significantly accelerating the pace at which their products will reach the SAR's market, according to the head of the center's preparatory office.

Hong Kong will be able to independently review the applications of innovative drugs for registration through the CMPR and no longer rely on approvals of other regulators, Lot Chan, assistant director of the city's health department, said in an exclusive interview with Yicai at the Drug Information Association China Annual Meeting held in Shanghai from May 13 through 16.

Drugmakers usually choose the European and US markets first in pursuit of high pricing when expanding overseas, but many of them have been discouraged by developed markets' extremely high access threshold, Chan pointed out.

"The European and US markets do not represent the entire market," he stressed, adding that the paths for pharmaceutical products to go global should be more diverse, especially in the current complex and volatile geopolitical context.

"Using Hong Kong as a springboard to introduce high-quality innovative drugs from the mainland to the vast emerging global markets is not only a very good alternative path but also an excellent strategic choice," Chan said.

"Thanks to its medical system in line with international standards, Hong Kong has become an important part of multi-center clinical trials for many multinational pharmaceutical companies, with its clinical data long recognized by European and US regulators," Chan noted. "However, the small population has become a major pain point restricting the development of the local drug regulatory system."

The establishment of the Greater Bay Area International Clinical Trial Institute‌ in Hong Kong at the end of 2024 and the inauguration of the Greater Bay Area International Clinical Trials Center in Shenzhen at the same time provided an opportunity for cross-border collaboration in clinical trials and to overcome the challenge of the relatively small population base for clinical trials in the SAR, Chan noted.

The population of the Guangdong-Hong Kong-Macao Greater Bay Area exceeds 87 million, so the cooperation among the clinical trial platforms will effectively coordinate the clinical resources and data throughout the region, he pointed out. "This will ensure that clinical trials fully meet the strict requirements for international registration of new drugs and make it smoother for medical products to apply for registration overseas."

In addition, Shanghai is an important base for the research, development, and production of biopharmaceuticals in China, so the CMPR plans to hold a series of seminars and promotional activities in the city to provide detailed explanations to mainland companies on Hong Kong's new drug review standards and registration mechanisms to make the SAR a golden channel for high-quality biopharmaceutical products from the mainland to go global, Chan said.

Previously, new drugs applying to register in Hong Kong needed to obtain approvals from two major overseas drug watchdogs and then undergo a formal review by local authorities. Starting from the end of 2023, the SAR also implemented the "1+" mechanism, making it so that after obtaining approval from one overseas drug regulator, the clinical trial data for Asian and local populations should be supplemented, and then a substantive review will be conducted by local authorities.

Hong Kong has approved 21 medical products through the "1+" mechanism, with more than a third being innovative drugs developed by mainland companies, according to Chan.

After the CMPR goes live, drugmakers can directly submit new drug approval applications to the center without relying on approval documents from any overseas authorities, he pointed out.

Editors: Tang Shihua, Martin Kadiev