Hong Kong Advances Health Innovation Initiatives with New Medical Regulation Center and Real-World Study Application Plans

Under Secretary for Health chairs third meeting of Steering Committee on Health and Medical Innovation Development

The Under Secretary for Health, Dr Libby Lee, chaired the third meeting of the Steering Committee on Health and Medical Innovation Development today (June 12) to have in-depth discussions on various key policy initiatives for promoting Hong Kong's development into an international health and medical innovation hub, including a roadmap for the establishment of the Hong Kong Centre for Medical Products Regulation (CMPR) and towards the adoption of "primary evaluation", proposals for establishing the Real-World Study and Application Centre (RWSAC), and the work on promoting clinical trial development.

A representative of the Department of Health (DH) reported on the latest developments in establishing the CMPR, and the strategic preparatory work for its long-term development into an internationally recognised regulatory authority for drugs and medical products, including the process for becoming a regulatory member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, with a view to gaining international recognition for drugs approved by the CMPR. The DH also proposed that Hong Kong should adopt a phased approach in advancing the "primary evaluation" system for new drugs. The Government will put forward the timetable for the establishment of the CMPR and the roadmap towards the adoption of "primary evaluation" within this month.

At the meeting, members were also briefed on the proposals for establishing the RWSAC. The Government is seeking to establish the RWSAC by the end of this year. The Centre aims to enhance the access to and application of health and medical databases, and to foster collaboration between Hong Kong and the Mainland in relevant areas, particularly in integrating real-world data generated through the special measure of using Hong Kong-registered drugs and medical devices used in Hong Kong public hospitals in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA), to achieve three major objectives: (1) to accelerate the research and development (R&D), approval and market launch of innovative medical products; (2) to promote the application of real-world data in support of evidence-based decision-making, thereby optimising treatment strategies and enhancing healthcare system efficiency; and (3) to develop Hong Kong into a leading region and global hub for real-world studies, with a view to attracting more international collaboration and investment.

In addition, members were briefed on the progress of the key initiatives undertaken by the Greater Bay Area International Clinical Trial Institute (GBAICTI). Officially established in the Hong Kong Park of the Hetao Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone in November last year, the GBAICTI has been actively advancing a number of clinical trial projects, including strengthening clinical trial collaboration with the two local medical schools, working jointly with the Greater Bay Area International Clinical Trials Center (BAY TRIAL) to promote the development of clinical trials and the biomedical industry, as well as establishing the GBA Clinical Trial Collaboration Platform with concerted efforts.

Members endorsed the above proposals and policy directions, and offered constructive comments. Dr Lee said, "I would like to express my heartfelt gratitude to the Steering Committee members for their invaluable insight to advise on the health and medical innovation development initiatives, and for recognising the direction of the Hong Kong Special Administrative Region (HKSAR) Government's work. The Policy Address has clearly stated the Government's commitment to developing Hong Kong into an international health and medical innovation hub. We are pressing ahead with the reform on the regulatory mechanism of drugs and medical devices, and to facilitate the translation and application of biomedical innovations. The timetable for the establishment of the CMPR and the roadmap towards the adoption of the "primary evaluation" will be announced shortly, along with the RWSAC which is targeted to be established by the end of this year, fully demonstrating our determination and operability to promote health and medical innovation. In addition, the co-ordinated development of the GBAICTI with BAY TRIAL in the Shenzhen Park under the 'one zone, two parks' model also marked a new chapter in cross-boundary collaboration.

"Hong Kong possesses the institutional advantages of 'one country, two systems' and professional strengths in the healthcare sector, providing unique conditions for advancing health and medical innovation. This strategic positioning is strongly supported by national policies, of which the 14th Five-Year Plan expressed clear support for Hong Kong's development into an international innovation and technology centre, while the Resolution of the Communist Party of China (CPC) Central Committee on Further Deepening Reform Comprehensively to Advance Chinese Modernization adopted by the Third Plenary Session of the 20th CPC Central Committee also pointed out the need of further reforming the medical and healthcare systems, and improving the mechanisms for supporting the development of innovative drugs and medical equipment. The HKSAR Government will leverage Hong Kong's unique advantages to expedite the provision of advanced diagnostic and treatment technologies to patients, and to promote co-ordinated development with other GBA cities, with the ultimate goal of bringing the benefits of good drugs and R&D to Hong Kong."

Established last year and chaired by the Secretary for Health, the Steering Committee on Health and Medical Innovation and Development comprises of members from relevant government bureaux and departments, institutions and local medical schools. The Steering Committee is responsible for co-ordinating and advancing work related to health and medical innovation, with a view to taking forward the policy of developing Hong Kong into an international health and medical innovation hub as set out in the Policy Address.

Under Secretary for Health chairs third meeting of Steering Committee on Health and Medical Innovation Development Source: HKSAR Government Press Releases

CFS to follow up certain batches of powdered infant and young children formula with possible presence of Cereulide produced by Bacillus cereus

The Centre for Food Safety (CFS) of the Food and Environmental Hygiene Department (FEHD) today (January 10) said that, it took initiative to meet with Nestlé Hong Kong again today, and confirmed the company's today announcement of an additional batch of powdered infant and young children formula suspected to have possibly used the raw material concerned. Nestlé Hong Kong has voluntarily stopped sales, removed from shelves the affected products and has initiated a precautionary recall. The CFS has collected samples of powdered infant and young children formula from the market for Bacillus cereus testing, the test results so far were satisfactory. The Environmental and Ecology Bureau is also closely monitoring the supply situation of other formula milk powder and maintaining communication with other major suppliers. It is noted that there is sufficient formula milk powder to meet the demand.

The spokesman said, the CFS has been actively following up on Nestlé company's voluntary and precautionary recalls of certain batches of its powdered infant and young children formula in certain areas in Europe due to possible presence of Cereulide produced by Bacillus cereus in the individual raw material. According to the latest information from Nestlé Hong Kong today, an additional batch of its powdered infant and young children formula imported into Hong Kong might have used the raw material concerned. The CFS had earlier enhanced surveillance in the market and collected a sample from the above batch for testing of Bacillus cereus. The test result of the sample was satisfactory. Nevertheless, as a precautionary measure, Nestlé Hong Kong has voluntarily stopped sales, removed from shelves the affected products and has initiated a precautionary recall.

Product details are as follows:

Product name (Net weight): NAN PRO 1 2 HMO (800g)

Batch number: 51670742F2

Best-before date: June 16, 2027

Place of Origin: Germany

"The CFS met Nestlé Hong Kong again today, urging them to properly handle the product recall issue and respond to public enquiries, in order to safeguard consumers' legitimate rights and interests. In addition, the CFS and Nestlé Hong Kong have jointly followed up, six suspected affected batches of infant and young children formula products that had not entered the market were marked and sealed. An additional 15 batches are currently en route to Hong Kong and will also be marked and sealed upon arrival. The CFS will continue to closely monitor the recall matters and remain fully committed to ensuring food safety, " the spokesman said.

Nestlé Hong Kong has initiated a recall of the affected batches of the products concerned. For enquiries about the recall, members of the public may contact the company through the following channels:

Consumer services hotline: 2599 8874 / 2797 6031/ 2179 8136 (Monday to Sunday, 9am to 9pm)

Email: consumerservices@hk.nestle.com

WhatsApp: 5283 4139 (NESTLÉ® NAN®) / 2599 8871 (Wyeth® Nutrition)

Online form: forms.office.com/e/BhqMhWfsUG?origin=lprLink

Consumers may choose to bring along the products (brand new or opened) for refund at place of purchase, or at exclusive service counters of Nestlé Nutrition Services from January 13 (Tuesday) onwards, to settle the recall and refund of the batches of the products concerned. Details of the exclusive service counters are as follows:

Kowloon Services Counter

Address: G/F, Park Hovan Commercial Building, 18 Hillwood Road, Tsim Sha Tsui, Kowloon (MTR Jordon Station Exit D)

Contact number: 3996 8196

Office hour: Monday to Saturday, 11am to 7.30pm; Sunday, 1pm to 5.30pm (except public holidays)

Hong Kong Services Counter

Address: 1/F, Ka Nin Wah Commercial Building, 423-425 Hennessy Road, Hong Kong (MTR Causeway Bay Station Exit B)

Contact number: 3996 8197

Office hour: Monday to Saturday, 11am to 7.30pm (except Sundays and public holidays)

The CFS, through its Food Incident Surveillance System, noted earlier that certain batches of Nestlé powdered infant formula were being voluntarily recalled in Europe due to possible contamination with Bacillus cereus. Upon learning of the incident, the CFS has immediately initiated follow up actions, published food incident posts to inform the public and the trade about the issue, and has been actively following up on the incident and enhanced surveillance.

Over the past three days (as of 4pm on January 9), the FEHD received a total of 18 food complaints and enquiries suspected to be related to the infant and young children formula products, including one anonymous complaint without contact information. The CFS and the Environmental Hygiene Branch have promptly followed up on all cases, including contacting the parties concerned to obtain details and collecting samples for testing. In addition, the CFS has referred the cases to the health department for follow-up. At present, no food poisoning cases related to the formula have been recorded.

Bacillus cereus is commonly found in the environment. Unhygienic conditions in food processing and storage may give rise to its growth. Cereulide is a heat-stable toxin produced in food by some strains of Bacillus cereus. Consuming food contaminated with excessive Bacillus cereus or its heat-stable toxins may cause gastrointestinal upset such as vomiting and diarrhoea.

The spokesman urged members of the public not to let infants and young children consume the affected batches of the products, and to seek medical treatment for infants or young children who felt unwell after taking the products concerned. The trade should also stop using or selling the affected batches of the products immediately.

"The CFS continues to closely monitor the developments of the situation, follow up and take appropriate action," the spokesman said.

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