LCQ9: Improving drug registration system
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Question:
The 2022 Policy Address proposes to improve the drug registration system, with a view to allowing medicines registered on the Mainland and in relevant places to be approved for registration and sale in Hong Kong. However, recently the Government has proposed that for medicines registered in four places, namely the Mainland, Brazil, Korea and Singapore, while application for registering in Hong Kong may be made, such medicines have to be granted concurrently a certificate of pharmaceutical product registration (certificate of registration) by one of the 32 countries originally listed in the Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity (the Guidance Notes) (the originally listed regions) in order to be approved for use in Hong Kong. In this connection, will the Government inform this Council:
(1) given that while the Guidance Notes require that medicines applying for registration in Hong Kong have to obtain beforehand a certificate of registration in two or more designated countries, the Government is currently dividing the places where certificates of registration are issued as set out in the Guidance Notes into two groups (i.e. the 32 originally listed regions as one group, and the four places, namely the Mainland, Brazil, Korea and Singapore, as another) and is imposing different requirements, whether the Government will consider combining the two groups together and aligning the 36 regions in a single tier, with a view to enabling a smoother cross-boundary introduction of pharmaceutical products from the Mainland and greater flexibility in Hong Kong's drug registration system; if so, of the details; if not, the reasons for that; and
(2) whether, in the long run, the Government will consider establishing a local medicine certification centre in Hong Kong, such that Hong Kong's drug registration system no longer relies on foreign countries' certification; if so, of the details; if not, the reasons for that?
Reply:
President,
Having consulted the Department of Health, the consolidated reply to the question raised by the Hon Joephy Chan is as follows:
According to the Pharmacy and Poisons Ordinance (Cap. 138), pharmaceutical products must satisfy the criteria of safety, efficacy and quality for registration with the Pharmacy and Poisons Board of Hong Kong before they can be sold or supplied in Hong Kong. Applicants for registration of pharmaceutical products are required to submit the necessary documents in accordance with the Guidance Notes on Registration of Pharmaceutical Products/Substances as promulgated by the Board. Applicants for registration of pharmaceutical product containing new chemical or biological entities (NCEs, i.e. contain active ingredients which have not been registered in Hong Kong) are required to provide documentary proof for registration of pharmaceutical products issued by at least two drug regulatory authorities of reference places in accordance with the Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity as promulgated by the Board, in order to provide supporting evidence that the product has been rigorously evaluated before placing in the market.
The aforementioned approval system is referred to as "secondary evaluation". That is, the Board relies on the registration approvals from the reference drug regulatory authorities which have conducted "primary evaluation" in order to evaluate applications for registration of pharmaceutical products containing NCEs. In this connection, "primary evaluation" involves the assessment of primary data and information of all pre-clinical studies (i.e. animal testing), clinical studies, manufacturing and quality control in order to fully evaluate the safety, efficacy and quality of medicine. "Primary evaluation" is generally conducted by highly developed and large-scale drug regulatory authorities (e.g. the Stringent Regulatory Authority (SRA) as designated by the World Health Organization (WHO)).
Under the "secondary evaluation" approach, the 32 pre-existing reference drug regulatory authorities that the Board referred to are members of the SRAs as designated by the WHO and have fully implemented the relevant guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The objectives to be achieved through the mechanism are, in principle, consistent with the objectives of drug regulatory systems adopted by other advanced economies and healthcare systems in the world, i.e. the NCEs approved by the Board satisfied the criteria of safety, efficacy and quality, and ensure the drug regulatory system of Hong Kong continues to be on par with the international standard and complement Hong Kong's leading position in healthcare standard.
The Board reviews the registration requirements of drug regulation mechanism from time to time. The Board noted that the Mainland China, Brazil, Korea and Singapore have joined the ICH and demonstrated good progress of promoting and implementing relevant ICH Guidelines and considered that the relevant regulatory systems have generally met the stringent requirements for becoming recognised drug regulatory authorities. As such, the four relevant drug regulatory authorities have been included in the reference list for the purpose of application for registration of pharmaceutical products containing NCEs since November 1, 2022.
Specifically, if one of the marketing authorisations submitted in the application for registration of pharmaceutical products containing NCE is from one of the four newly added drug regulatory authorities, the local registration requirement would be considered as being fulfilled provided that the applicant have submitted another documentary proof of the registration of pharmaceutical product issued by one of the pre-existing authorities. This requirement is basically in line with the current arrangement. Nevertheless, since the four aforementioned drug regulatory authorities are not SRAs as designated by the WHO and are yet to fully implement the relevant guidelines of the ICH, at this stage, application for registration of pharmaceutical products containing NCEs cannot solely rely on the documentary proof of registration of pharmaceutical products issued by the four newly added regulatory authorities. The Government will continue to closely monitor the relevant development and make adjustments according to the actual circumstances as appropriate.
Maintaining a drug regulatory system that is on par with the international standard while extending the list of reference drug regulatory authorities would facilitate the future development of our local healthcare system and services as well as maintaining international recognition of healthcare technology and clinical research. At the same time, the Government would also evaluate the feasibility of conducting "primary evaluation" with regard to factors such as the relevant development and overall complementary arrangements in the Greater Bay Area as appropriate.
Ends/Wednesday, December 14, 2022
Issued at HKT 15:41
Issued at HKT 15:41
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