The Centre for Medical Products Regulation Bill was published today in the Government Gazette, establish statutory status for the Centre for Medical Products Regulation (CMPR) and to allow the regulatory framework for Chinese and Western medicines and medical devices to be unified in the future.

The bill will be introduced into the Legislative Council for first reading on November 25.

The bill includes three major proposals. First, to establish the CMPR as a body corporate to represent Hong Kong, China in international regulatory affairs concerning medical products and establish formal, long-term working relationships with leading regulatory authorities worldwide.

Second, to unify the regulatory framework, the bill proposes to build on existing legislation to transfer the relevant regulatory powers and functions concerning Chinese and Western medicine, currently vested in the Pharmacy and Poisons Board of Hong Kong, the Chinese Medicines Board of the Chinese Medicine Council of Hong Kong and their committees, as well as those relating to medical devices, after legislation in the future, to the Director of Health.

Third, to enhance the relevant supporting mechanisms and make necessary technical amendments.

Secretary for Health Prof Lo Chung-mau said the establishment of the CMPR marks a significant milestone in Hong Kong's regulatory reform of medical products.

He added that the Government will comprehensively and proactively align with the National 15th Five-Year Plan, fully leveraging Hong Kong's distinctive advantages of enjoying strong support nationally and being connected to the world under the “one country, two systems” principle.

“We will establish a proactive mechanism for the evaluation and approval of medical products, enabling advanced products to be introduced into Hong Kong more quickly for the benefit of patients and developing Hong Kong into an international health and medical innovation hub,” he said.

The health chief added that the Government will deepen collaboration with regulatory authorities around the world and pursue recognition from international authorities.

“Our long-term goal is to develop the CMPR into an internationally recognised regulatory authority for medical products."

Prof Lo emphasised that the Government is committed to providing a world-class and modern regulatory environment to accelerate the clinical application of innovative medical products while ensuring their safety, quality and efficacy, making good drugs and medical devices available for use in Hong Kong.

The Government will also support the emerging biomedicine industry in its research and development regarding innovative medical products, facilitating their introduction into Hong Kong and expansion into international markets, he said.