Published: 16:58, October 25, 2024 | Updated: 17:36, October 25, 2024
HK to expand drug registration mechanism to all new drugs on Nov 1
By Wu Kunling in Hong Kong
In this Feb 4, 2020, file photo, medical staff are seen outside Princess Margaret Hospital in Hong Kong. (PHOTO / AFP)

Starting from November, all new drugs, including vaccines and advanced therapy products, can be registered in Hong Kong via the simplified 1+ mechanism.

The move is designed to push the city towards becoming “an international health and medical innovation hub”.

Announcing the news on Friday, the Department of Health said the extension of the mechanism will open Hong Kong up to new drugs from different parts of the world, thus giving patients greater choice and further strengthening the city’s capacity for drug evaluation.

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The authority also pledged that it will complement technological innovation with institutional innovation, developing Hong Kong into an international health and medical innovation hub.

The expansion, announced in the third Policy Address of Chief Executive John Lee Ka-chiu on Oct 16, is one of the key measures to promote Hong Kong’s development.

The new mechanism for registration of new drugs was implemented last November.

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According to the mechanism, known as “1+”, new drugs used for the treatment of life-threatening or severely debilitating diseases that are supported by clinical data and whose scope of application is recognized by relevant experts are required to submit approval from one drug regulatory authority (instead of two in the past) for application for registration in Hong Kong.

Through reforming the approval mechanism for drugs and medical devices, the government aims to make good drugs available in Hong Kong.

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A Department of Health spokesperson also revealed that since the implementation of the mechanism, the department has received more than 260 enquiries from over 80 pharmaceutical companies, including those from overseas and the Chinese mainland. 

Five new drugs have been approved under this mechanism. These included two new drugs for treating metastatic colorectal cancer, one for treating paroxysmal nocturnal haemoglobinuria, and two new drugs for treating hypercalcaemia in patients with parathyroid carcinoma and in certain patients with primary hyperparathyroidism, bringing new hope for treatment to patients.