LCQ22: Drug registration system
Under the existing arrangement, for applications for registration of pharmaceutical products containing a new chemical or biological entity (new drugs), applicants for registration need to provide, in accordance with the Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity promulgated by the Pharmacy and Poisons Board of Hong Kong (the Board), documentary proofs of registration issued by the drug regulatory authorities of two or more specified reference places (secondary evaluation). After the Chief Executive had put forward the improvement of the drug registration system in the 2022 Policy Address, the Board added the drug regulatory authorities in four places (i.e. the Mainland, Brazil, Korea and Singapore) to the list of specified reference places under secondary evaluation on November 1, 2022, so as to enable drugs registered on the Mainland and in relevant places to be registered and used in Hong Kong. In this connection, will the Government inform this Council:
(1) of the number of new drugs approved for registration in Hong Kong in each of the past three years, with a breakdown by the place where the drug regulatory authorities issuing documentary proofs of registration were located; the average time taken for vetting and approving the applications concerned;
(2) given that the Hospital Authority (HA) allows the use of unregistered drugs by clinicians under special circumstances having regard to the clinical needs of individual named patients, of the number of applications for using unregistered drugs on named patients received by HA in each of the past three years, with a breakdown by the type of these drugs; and
(3) of the respective numbers of applications for registration of new drugs from those four places which have been received, approved and rejected by the Board since the drug regulatory authorities in the aforesaid four places were added to the list of specified reference places; the justifications for rejecting the applications; whether the Board has taken the initiative to publicise to the pharmaceutical companies in those places, so as to attract the registration of drugs from those places in Hong Kong?
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 (Board) 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. Generally speaking, applicants for registration of pharmaceutical product containing new chemical or biological entities (NCEs, i.e. containing active ingredients which have not been registered in Hong Kong) are required to provide necessary information including documentary proof for registration 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 Department of Health (DH) is responsible for providing professional and executive support to the Board.
Having consulted the DH and the Hospital Authority (HA), the reply to the question raised by the Hon Joephy Chan is as follows:
(1) From 2020 to 2022, the Board approved 217 applications for registration of pharmaceutical product containing NCEs (the number of applications for registration of pharmaceutical product containing NCEs approved in 2020, 2021 and 2022 were 58, 67 and 92 respectively), and over 80 per cent of documentary proof of the registration submitted by the relevant applicants were issued by drug regulatory authorities of Europe, Australia, Canada or the United States. The DH has pledged that no less than 90 per cent of applications for pharmaceutical product registration would be processed within five months upon the submission of all required documents by the applicants. Over the past three years, the DH fulfilled the above performance pledge. During 2020 to 2022, 99.4 per cent of the applications were processed within five months on average upon the receipt of all required documents.
(2) Drugs listed on the Hospital Authority Drug Formulary (HADF) are intended for HA-wide use benefitting the entire local population. Clinicians may prescribe drugs outside HADF under exceptional situations, including unregistered drugs such as those for treating malignant diseases and immunosuppression, in order to cater for the clinical needs of individual patients. The use of drugs outside the HADF is an integral part of healthcare services to take into account the needs of general citizens and certain individuals, such that patients are provided with appropriate clinical care. Clinicians would prescribe appropriate medical treatments based on their clinical expertise and professional judgment, taking into consideration the clinical conditions of individual patients.
The following table sets out the number of drug items outside the HADF prescribed in HA from 2020-21, 2021-22 and 2022-23 (up to December 31, 2022):
|Number of drug items outside the HADF prescribed||204||216||215*|
As a drug may have various clinical indications or dosages which may fall into therapeutic classes of different specialties, the HA is unable to provide a breakdown by therapeutic classifications. The above figures reflect the number of drug items instead of the number of drug outside the HADF used each year. The HA currently does not maintain statistics on the number of registered or unregistered drug outside the HADF used.
(3) The Board reviews the registration requirements of drug regulation from time to time. Since November 1, 2022, it has included the regulatory authorities of Mainland China, Brazil, Korea and Singapore to the list of reference places for the purpose of registration of pharmaceutical products containing NCEs. Furthermore, since February 23, 2023, applications for registration of NCEs are only required to submit documentary evidence of registration issued by any two or more of the aforementioned four newly added reference drug regulatory authorities or the 32 pre-existing reference drug regulatory authorities (i.e. out of 36 in total).
Upon updating the list of reference places on November 1, 2022, the Board has received five applications involving the four newly added drug regulatory authorities. Three of those applications have been approved, while the remaining two are being processed.
Upon updating the list of reference places for registration of NCEs, the DH immediately promulgated the arrangement on relevant websites, issued letters to notify the relevant stakeholders (including the relevant pharmaceutical associations, certificate holders of registered pharmaceutical products, as well as the regulatory authorities of Mainland China, Brazil, Korea and Singapore), and also updated the relevant Guidance Notes (including the Guidance Notes on Registration of Pharmaceutical Products/Substances, Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity, etc.).
Ends/Wednesday, March 15, 2023
Issued at HKT 16:20
Issued at HKT 16:20