Hong Kong's New Agency Boosts Mainland Drugs’ Speed to Market

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The independent drug regulator set to launch in Hong Kong by the end of this year will enable mainland Chinese innovative drug companies to submit local market applications while simultaneously registering with the National Medical Products Administration. This is expected to substantially speed up the process of bringing new products to the region’s market, according to the head of the center’s preparatory office.

Hong Kong will now have the ability to independently review innovative drug registration applications, no longer needing approval from other regulators. The assistant director of the city’s health department, in an exclusive interview at the Drug Information Association China Annual Meeting held in Shanghai from May 13 to 16, shared this update.

Typically, pharmaceutical companies target European and US markets first when expanding abroad, driven by the potential for higher pricing. However, many are deterred by the strict entry requirements in these developed markets, noted the official.

“But these markets don’t cover the entire global demand,” he emphasized, adding that there should be more diverse pathways for pharmaceutical products to access global markets, especially given the current complex and unpredictable geopolitical landscape.

“Using Hong Kong as a launch pad for introducing high-quality innovative drugs from mainland China to emerging markets worldwide is not only a promising alternative route but also a strategic opportunity,” he explained.

Thanks to its world-class healthcare system, Hong Kong has become a vital hub for multinational pharmaceutical companies conducting multicenter clinical trials, with its clinical data highly regarded by European and US regulatory agencies. However, its relatively small population has posed challenges for developing the local drug regulatory framework.

The planned establishment of the Greater Bay Area International Clinical Trial Institute in Hong Kong by late 2024, along with the launch of the Greater Bay Area International Clinical Trials Center in Shenzhen, will foster cross-border collaboration in clinical research. This will help overcome the population limitations of the Hong Kong SAR. The combined population of the Guangdong-Hong Kong-Macao Greater Bay Area exceeds 87 million, enabling better coordination of clinical resources and data across the region, ensuring compliance with international standards for new drug registration and facilitating smoother overseas approval processes.

Additionally, since Shanghai remains a key city for biopharmaceutical research, development, and manufacturing in China, the regulators plan to organize a series of seminars and promotional events in the city. These sessions aim to inform mainland companies about Hong Kong’s new drug review standards and registration procedures, transforming the SAR into a vital channel for launching high-quality biopharmaceutical products globally from mainland China.

Previously, new drugs seeking registration in Hong Kong needed approvals from two major foreign regulatory agencies before undergoing a local assessment. Starting at the end of 2023, the “1+” mechanism was introduced, allowing drugs that have been approved by one overseas regulator to proceed with supplementary clinical data relevant to Asian and local populations before the local authorities conduct their thorough review.

Hong Kong has approved 21 medical products through this mechanism, with over a third developed by mainland Chinese companies, the official noted.

Once the new center becomes operational, pharmaceutical firms will be able to submit new drug applications directly to it, bypassing the need for prior approval documentation from other international agencies.