What Changed
- Registration approval of a prostate cancer drug under the '1+' mechanism following Mainland regulatory approval and local expert assessment.
- Reduction of registration evaluation times for initial phase cancer treatments under the Priority Review Pathway from up to 150 working days to no more than 100 working days.
- Progress toward full 'primary evaluation' drug coverage by 2030 and planned establishment of the Hong Kong Centre for Medical Products Regulation by late 2026.
Pharmaceutical companies, healthcare providers, and patients with metastatic hormone-sensitive prostate cancer in Hong Kong SAR are directly affected by the Hong Kong Special Administrative Region (HKSAR) Government's approval of a new drug under the '1+' drug approval mechanism.
Announced by a Government spokesman on October 15, 2026, the decision brings the total number of new drugs approved for registration under this mechanism to 23. The newly approved drug, indicated for metastatic hormone-sensitive prostate cancer, was previously approved by the drug regulatory authority on the Chinese Mainland. Following an evaluation of clinical data and relevant information submitted by the applicant, as well as advice from a local expert, the Registration Committee under the Pharmacy and Poisons Board of Hong Kong concluded that the drug satisfied required criteria for safety, efficacy, and quality. The Department of Health (DH) has officially notified the applicant of the approval.
The '1+' mechanism was initially implemented on November 1, 2023, for serious or rare diseases, and was extended on November 1, 2024, to cover all new drugs—including new chemical or biological entities, new indications, vaccines, and advanced therapy products. Under this framework, applicants supported by local clinical data and local expert recognition can apply for registration in Hong Kong SAR by submitting proof of approval from one reference drug regulatory authority, down from the previous requirement of two authorities.
To date, seven of the 23 drugs approved under the '1+' mechanism have been listed in the Hospital Authority Drug Formulary (HADF), with six categorized under the 'Special Drug' category. When prescribed for specified clinical applications, patients pay a standard fee of $20 every four weeks. Alongside the establishment of the Office for Introducing Innovative Drugs and Medical Devices on June 8, 2026, a Priority Review Pathway reduces evaluation times for initial-phase cancer treatments from up to 150 working days to no more than 100 working days. Furthermore, the DH began phased implementation of 'primary evaluation' on March 31, 2026, aiming for full coverage of all pharmaceutical products by 2030 and the establishment of the Hong Kong Centre for Medical Products Regulation by the end of 2026.
Who May Be Affected
Pharmaceutical enterprises in Mainland China and overseas, healthcare providers, and prostate cancer patients in Hong Kong SAR.
Cross-Border Context
The framework utilizes single reference authority approvals (including from Mainland China) to enable faster drug registration in Hong Kong SAR and align with the National 15th Five-Year Plan.
What to check next
- Establishment details of the Hong Kong Centre for Medical Products Regulation by late 2026.
- Future additions of '1+' approved drugs to the Hospital Authority Drug Formulary.
This article provides general information and does not constitute legal advice. Consult the official text and obtain advice appropriate to your circumstances where needed.