Hong Kong Advances Medical Product Regulation with New Evaluation Roadmap and Innovation Symposium

DH organises Medical Products Regulation Symposium to familiarise trade with timetable and roadmap for Hong Kong's move towards "primary evaluation" of medical products

The Department of Health (DH) and the Hong Kong Science and Technology Parks Corporation (HKSTP) today (February 3) co-organised the Medical Products Regulation (MPR) Symposium to brief representatives from local and mainland regulatory authorities, academia, research institutions and the trade on the timetable and roadmap towards the adoption of "primary evaluation" of medical products in Hong Kong.

The Symposium was held under the theme of "the Future of Medical Products Regulation". The DH highlighted the latest developments in the regulation of medical products in Hong Kong, with a view to promoting research, development and clinical trials, thereby enabling more patients to have earlier access to advanced medical treatments and diagnostics. Representatives from the HKSTP shared the measures to promote medical products innovation, while representatives from the trade introduced the latest developments in the clinical research ecosystem.

Delivering his opening remarks, the Director of Health, Dr Ronald Lam, said, "The year 2026 will mark a significant milestone for the development of innovative drugs and medical device regulations in Hong Kong, China. 'The Chief Executive's 2025 Policy Address' announced that the Government will set up the Hong Kong Centre for Medical Products Regulation (CMPR) in 2026, and implement the 'primary evaluation' mechanism for new drug registration in phases starting from that year, enabling Hong Kong to independently assess and approve the safety and efficacy of medical products based on clinical data, with a view to developing Hong Kong into an internationally recognised authority on medical products regulation. The establishment of the 'primary evaluation' mechanism will help expedite the development of innovative medical products, thereby achieving the goal of making good drugs and medical devices available for use in Hong Kong."

Regarding the phased implementation of "primary evaluation", the initial phases will cover applications for the registration of products containing registered chemical entities with extended applications (e.g. new indications, new strengths, new posology, new dosage forms, etc). This will progressively establish a robust approval system, providing strong momentum for the development and market expansion of the healthcare industry in Hong Kong, the Chinese Mainland, and beyond.

"The Government will also submit a legislative proposal on regulating medical devices this year. We encourage the trade to submit applications to list their medical devices under the Medical Device Administrative Control System early, so as to be better prepared for the transition to the future statutory framework," Dr Lam said.

"The DH has been closely monitoring technological developments in innovative medical devices and has issued guidance in a timely manner, such as technical reference documents for the listing of artificial intelligence medical devices, to assist the trade in understanding the relevant requirements. We firmly believe that promoting collaboration among industry, academia and research institutions is of vital importance. To this end, we have stepped up our efforts to communicate and engage with stakeholders, which is also the purpose of this Symposium. We hope that all sectors will work together to lay a solid foundation for Hong Kong's development as an international medical innovation hub, while contributing to our country's efforts to become one of the forerunners in health and medical innovation," Dr Lam added.

This year, with strong support from the National Medical Products Administration, the DH will host the annual meeting of the Global Harmonization Working Party (GHWP). Representatives from global medical device regulatory authorities and industry leaders will gather in Hong Kong, laying the initial foundation for the future role of the CMPR in connecting and establishing a global medical products regulatory system, and even becoming a forerunner in this field.

Additionally, the DH began offering one-on-one pre-new drug application meetings last December for potential applicants for new drugs registration through the "1+" mechanism. Dr Lam urged the pharmaceutical industry to actively apply, working together to achieve the goals of early consultation to enhance quality and efficiency throughout the process so that registration approval can be expedited in Hong Kong, thereby consolidating Hong Kong's position as an international health and medical innovation hub. This service aims to further optimise the new drug registration approval process, and no fees will be charged for this service at this stage.

The Symposium was attended by over 700 participants today. The DH will continue to work closely with different stakeholders to refine regulatory processes and strengthen regional and international collaboration, so as to fully leverage Hong Kong's role as a "super connector" and "super value-adder".

DH organises Medical Products Regulation Symposium to familiarise trade with timetable and roadmap for Hong Kong's move towards "primary evaluation" of medical products Source: HKSAR Government Press Releases

DH organises Medical Products Regulation Symposium to familiarise trade with timetable and roadmap for Hong Kong's move towards "primary evaluation" of medical products Source: HKSAR Government Press Releases

DH organises Medical Products Regulation Symposium to familiarise trade with timetable and roadmap for Hong Kong's move towards "primary evaluation" of medical products Source: HKSAR Government Press Releases

CFS urges public not to consume batch of powdered infant formula

The Centre for Food Safety (CFS) of the Food and Environmental Hygiene Department continues to actively follow up on the precautionary recall of certain batches of powdered infant and young children formula in different areas worldwide due to possible presence of Cereulide produced by Bacillus cereus in the individual raw material. The CFS today (February 3) said it earlier noted through its Food Incident Surveillance System that certain batches of Aptamil powdered infant and young children formula are being recalled by the German authority as the products might contain Cereulide produced by Bacillus cereus. The CFS has been very concerned about the incident, and has followed up immediately, including contacting the local importers, retailers and relevant authorities, as well as inspecting retail outlets in the market. The CFS has earlier published a food incident post online to inform the public and the trade of the incident. According to the latest investigation result today, a local retailer had sold a small quantity of one affected batch of the powdered infant formula concerned. For the sake of prudence, the retailer concerned has stopped sales, removed from shelves the affected product and has initiated a precautionary recall according to the CFS's instructions.

Product details are as follows:

Product name: Aptamil Profutura DUO Pre D 800g

Brand: Aptamil

Pack size: 800 grams

Place of origin: Germany

Quantity imported: 54 cans

Use-by date: April 20, 2027

Retailer: Baby HK

A preliminary investigation by the CFS revealed that relevant importer had imported nine boxes of 54 cans of the product concerned, among which 34 cans had been distributed. The CFS has instructed the retailer concerned to stop sales and remove from shelves the affected batch of the product concerned and to initiate a recall. Moreover, the CFS has marked and sealed 20 cans of remaining stock of the product. Members of the public may call the retailer's hotline at 3586 1399 during office hours for enquiries about the recall.

The CFS will continue to enhance surveillance of powdered infant and young children formula and to closely monitor the recall matters and remain fully committed to ensuring food safety. The CFS has alerted the trade and relevant department over the incident, and will continue to follow up and take appropriate action. Follow-up investigation is ongoing.

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

The CFS has established a designated webpage (www.cfs.gov.hk/english/whatsnew/powdered_formula/index.html) to facilitate public access to more information.

Source: AI-found images