Hong Kong's Department of Health (DH) is set to launch comprehensive consultation services to help pharmaceutical companies navigate the territory's streamlined "1+" drug registration mechanism, aiming to enhance efficiency and accelerate patient access to new medications.
The initiative comes after the successful implementation of the "1+" mechanism in November 2023, which reduced regulatory requirements by allowing pharmaceutical products to be registered with approval from just one reference drug regulatory authority, down from the previously required two.
New Consultation Services to Expedite Drug Approvals
The Department of Health will roll out a three-tiered approach to consultation services, beginning with an online briefing seminar on March 31, followed by specialized workshops in June, and culminating with face-to-face pre-registration consultation meetings in the latter part of the year.
"They are not quite sure or quite understand our registration requirements," explained Assistant Director of Health Frank Chan, referring to overseas and mainland pharmaceutical companies unfamiliar with Hong Kong's regulatory framework. "Once they got the information, they may discuss with their company to see whether they want to go ahead with the applications... so that we [don't have] to go back and forth to ask them to provide the supplementary information."
The introductory seminars and workshops will be offered free of charge, while the department is considering implementing cost recovery fees for the more resource-intensive pre-registration consultation meetings, which involve preliminary document review by regulatory staff.
Impact of the "1+" Mechanism
Initially limited to drugs treating life-threatening or severely debilitating diseases, the "1+" mechanism was expanded in November 2024 to encompass all new drugs. To qualify under this pathway, products must have recognized local clinical data and expert endorsement, in addition to approval from a reference regulatory authority.
The streamlined process has already shown promising results. According to the Department of Health, eleven new drugs have been registered under the "1+" mechanism, with five already added to the Hospital Authority's formulary. These additions have led to significant cost savings, with the Hospital Authority reporting price reductions of 30-35% and annual savings between HK$15-24 million.
Industry Response
The pharmaceutical industry has shown considerable interest in the new registration pathway. As of mid-March 2025, the Department of Health had received over 400 inquiries from more than 110 pharmaceutical companies regarding drug registration matters under the "1+" mechanism. Approximately 15% of these inquiries were verbal, while 85% were submitted in writing.
The consultation services are strategically designed to address different stakeholder needs. The introductory seminars will provide general information about Hong Kong's drug registration requirements and the "1+" mechanism. The workshops will offer more practical guidance for regulatory affairs personnel, submission assistants, and staff from registration consultancy firms. The pre-registration consultation meetings will specifically target pharmaceutical companies capable of producing drugs and those seeking or already having market presence in reference countries.
Future Outlook
The Department of Health's initiative represents a significant step toward modernizing Hong Kong's pharmaceutical regulatory framework and aligning it with international standards while maintaining rigorous safety and efficacy requirements.
By reducing regulatory redundancies and providing clearer guidance to industry stakeholders, Hong Kong aims to position itself as an attractive market for innovative pharmaceuticals, potentially leading to earlier access to novel therapies for patients in the territory.
The success of this initiative will likely be measured by the number of new drug applications, approval timelines, and ultimately, the availability of innovative treatments for patients in Hong Kong.
