Key points
- Phase 1 of primary evaluation commenced on 31 March 2026.
- The initial phase covers locally registered chemical entities with extended applications (new indications, strengths, posology, dosage forms).
- The revamped regime establishes six application categories and three evaluation routes.
- Full coverage of all pharmaceutical products is targeted by 2030, in four phases.
A press release was issued on 31 March 2026 to announce that the Department of Health ("the DH") has begun the phased implementation of "primary evaluation" for new drug registration on the same day.
A letter was also issued by the Pharmacy and Poisons Board of Hong Kong ("the Board") on 31 March 2026 to inform pharmaceutical associations and stakeholders of the Board's endorsement of the revamped drug registration regime and the publication of new and revised guidance notes for application for registration of pharmaceutical products, with a view to implementing phase 1 of primary evaluation, which has come into effect on 31 March 2026.
As mentioned in "The Chief Executive's 2025 Policy Address", the Hong Kong Special Administrative Region ("HKSAR") Government would establish the Hong Kong Centre for Medical Products Regulation ("CMPR") in 2026 and begin the phased implementation of the "primary evaluation" mechanism for new drug registration in the same year.
The HKSAR Government aims to achieve full coverage of all pharmaceutical products by 2030, which will enable Hong Kong to independently assess and approve the safety and efficacy of new drugs based on clinical data, with a view to expediting the introduction of innovative medical products.
On 26 June 2025, the DH announced the timetable for the establishment of CMPR by the end of 2026 and the roadmap towards adoption of primary evaluation in Hong Kong for pharmaceutical products. In accordance with the roadmap, the primary evaluation approach would be prudently implemented in four phases in the period between 2026 and 2030.
"Primary evaluation" is a regulatory process to approve applications for registration of new drugs which involves an independent assessment of primary data and information of all pre-clinical studies (i.e. animal testing), clinical studies, pharmacovigilance, manufacturing and quality control, etc. in order to fully ensure their safety, efficacy and quality before and after the drugs are placed in the market (i.e. throughout the product life-cycle).
Registering new drugs under the "primary evaluation" mechanism facilitates immediate approval without relying and waiting for approval from non-local drug regulatory authorities, which further speeds up introduction of new drugs and clinical applications. This will not only help speed up patients' access to breakthrough treatments but also boost medical R&D, testing and related industries in Hong Kong.
The DH has commenced the Phase 1 of primary evaluation for new drug registration on 31 March 2026, and the initial phase covers applications for registration of drug products containing locally registered chemical entities with extended applications (e.g. new indications, new strengths, new posology, new dosage forms, etc.).
For the purpose of conducting primary evaluation of applications for initial registration of pharmaceutical products, the Board has endorsed the revamped registration regime of pharmaceutical products, which includes the categorization of initial registration applications into six application categories and the formulation of three evaluation routes.
To reflect the revamped drug registration regime and requirements for primary evaluation, new sets of Guidance Notes are published and relevant Guidance Notes have been updated and uploaded to the website of the Board and the Drug Office of the Department of Health accordingly.
The DH held three briefing seminars on the revamp of drug registration regime and phase 1 of primary evaluation in April 2026. The six categories of initial registration applications established, the three evaluation routes formulated, and the corresponding new and revised guidance notes were elaborated during the sessions.
The three seminars were well-attended by 191 representatives from pharmaceutical and consultation companies inside or outside Hong Kong, as well as scientific research institutions. The Drug Office of the DH has also prepared a briefing video to facilitate traders to understand primary evaluation.