End-to-end support for pharmaceutical companies navigating the Department of Health approvals and regulatory requirements.
Determining the correct regulatory pathway for your product.
Preparing and managing Department of Health applications for new and existing pharmaceutical products.
Managing variations and amendments to products already registered in Hong Kong, keeping your registration accurate and compliant over time.
We are a small but dedicated team of regulatory specialists in Hong Kong. Over the years, we have worked with clients from different countries, helping them register products, maintain registrations, and make changes to registered products.
Most of our clients want a quick turnaround and clarity on the registration process. That is where our team comes in.
We don’t just pass along what we are given to the Department. We carefully review every submission package and provide feedback before it goes in. We actively follow up with the Department to seek clarity and monitor progress.
Our goal isn’t just to make a submission on your behalf. We promise our clients the care and due diligence they deserve, so their products get registered in Hong Kong as soon as we humanly can.
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.
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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.
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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.
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