HK traditional Chinese medicine sector gearing up for GBA market

Amy Liu Mei Heung September 26, 2021 06:00

A delegation from the Central Government recently visited Hong Kong to promote the 14th Five-Year Plan, calling on Hong Kong people to seize the opportunity to integrate with the country’s overall development. The “Construction Plan for the Chinese Medicine Highlands in the Guangdong-Hong Kong-Macao Greater Bay Area (2020-2025)” has proposed policies that benefit Hong Kong people and their businesses, and the industry is expecting the introduction of more effective measures.

When addressing the migration of talents to the Greater Bay Area, Huang Liuquan, Deputy Head of the Hong Kong and Macao Affairs Office of the State Council, encouraged Hong Kong’s practitioners of Traditional Chinese Medicine (TCM) to work in public medical institutions in the Greater Bay Area (GBA). By the end of last year, there were 10,422 TCM practitioners in Hong Kong. With many Hong Kong students returning after completing an undergraduate degree in TCM on the Mainland, there is now a surplus of TCM practitioners. According to the Government’s projection, a surplus of around 1,600 TCM practitioners will be generated in the coming decade. The Guangdong Provincial Government announced last month that the GBA welcomes young people with professional or related qualifications in TCM. This creates a new opportunity for Hong Kong graduates with a Mainland degree in TCM.

Expediting drug review and approval

In July, Our Hong Kong Foundation published a report titled “Strategic Collaborations between Hong Kong and Shenzhen in Biotechnology – Capitalising Opportunities in the Loop for Policy Innovations”. To accelerate the development of biotechnology in the GBA, especially in the Lok Ma Chau Loop, the report recommended the Central Government expedite the review and approval of drugs by bridging the gap between Hong Kong and Shenzhen’s regulatory systems.

The Central Government recently announced that it will simplify Mainland’s registration and approval procedures for Hong Kong’s proprietary Chinese medicines (pCms) for external use. The new procedures will make pCms commonly used by Hong Kong people, such as White Flower Oil and medicated balm, more readily available in Guangdong Province. The registration and approval of pCms for use in Hong Kong and Macao were previously reserved for the National Medical Products Administration, but now the procedures will be streamlined and delegated to the Guangdong Medical Products Administration. In terms of application materials, data from a new round of clinical trial is no longer needed and only information on research and trails submitted then for registration in Hong Kong and Macao will be required. The timeframe of approval has also been reduced from 235 days to 115 days.

Under the new policy, for pCms approved for external use by the Chinese Medicine Council of Hong Kong and used in Hong Kong for more than five years, their registered holders can submit applications for registration to the Guangdong Medical Products Administration, and the approved products can be sold in the GBA.

According to Hong Kong’s Department of Health, this policy is restricted to the 200 or so registered TCM manufacturers in Hong Kong, but does not apply to the thousands of wholesalers. The industry is hoping that the registration process could be simplified for licensed wholesalers as well. Another concern is that the new procedures only cover pCms for external use and exclude those for internal use. A case in point is a manufacturer of pCms for internal use in Hong Kong. Its formulated granule product was developed some years ago, but the approval on the other side of the border came only after two years of efforts, resulting in slow sale progress on the Mainland.

Moreover, the industry believes that the Hong Kong Government is lagging behind in the approval of Chinese medicines. At the moment, the Chinese Medicine Ordinance imposes more stringent regulation of pCms manufactured in Hong Kong by requiring good manufacturing practices for pCms, providing for the transition of pCms registration from “HKP” to the stricter “HKC”. However, one of the TCM manufacturers applied for HKC certificates seven years ago and is yet to receive one for their pCms for external use. Without the new certificates issued by Hong Kong, it is questionable whether these pCms can benefit from the streamlined approval procedures on the Mainland.

Enhancing the Chinese Medicine Development Fund

In the 2018-19 Budget, the Government earmarked $500 million for the Chinese Medicine Development Fund, which aimed to provide financial support to the sector and improve its overall standards, including training talents for TCM hospitals, sponsoring related scientific research and raising public awareness of TCM. The Fund was launched in June 2019.

To support the re-industrialisation of SMEs, the Hong Kong Productivity Council assisted the TCM sector in making their production more modernised and more competitive. The Food and Health Bureau is currently reviewing the operation of the Fund, including the contents and results of the sponsored projects, with a view to running more effective projects and optimising the Fund’s resources.

Both the Central Government and the Guangdong Provincial Government have formulated policies to promote the development of the TCM industry and to establish the GBA as a TCM hub in the country. The Hong Kong Government should also expedite the approval process for TCM and invest more resources to support the industry’s development, to enable a stagnant sector to flourish again.

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Amy Liu Mei Heung

Managing Editor at Our Hong Kong Foundation.