Blog — Kanafay

Blog

Our blog

Practical guidance on registering pharmaceutical products and staying compliant in Hong Kong.

October 14, 2026

Refinement of the Requirements for Applications for Change of Registered Particulars Related to Indication, Dosage and Route of Administration

From 29 November 2025, applications to change the indication, dosage or route of administration of registered NCE products may be accepted with proof of approval from just one reference country.

October 14, 2026

Implementation of Phase 1 of Primary Evaluation for New Drug Registration

The Department of Health began Phase 1 of "primary evaluation" for new drug registration on 31 March 2026, a first step toward Hong Kong independently assessing drug safety and efficacy.

October 14, 2026

Updates on Registration of Pharmaceutical Products under the "1+" Mechanism

Hong Kong's "1+" mechanism now includes a Priority Review Pathway for innovative drugs, cutting evaluation time for cancer treatments to within 100 working days.