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Following is a question by the Hon Andrew Cheng and a written reply by the Secretary for Food and Health, Dr York Chow, in the Legislative Council today (June 10):
Question:
Regarding the regulatory system for drugs, will the Government inform this Council whether:
(a) it has found out if the drugs produced by Hong Kong pharmaceutical manufacturers with Good Manufacturing Practice (GMP) certification may be sold in the European Union (EU) and the United States (US); whether it knows if the drugs produced by the pharmaceutical manufacturers with GMP certification by the authorities in Australia, Japan, Singapore or other Asian countries may be sold in EU;
(b) it will study enhancing the GMP guidelines in Hong Kong to set their standards not lower than those in Australia and Singapore; if it will, of the details and the relevant timetable; if not, the reasons for that;
(c) the authorities recognise the GMP certification issued by the mainland authorities of the national and provincial levels; if so, of the authorities' measures to ensure that the GMP guidelines are strictly followed, and whether they know if the authorities in EU, Australia, the US, Japan and Singapore recognise such certifications; and
(d) findings of bioequivalence evaluation studies on generic drugs (i.e. non-patent drugs) have to be provided to prove that their efficacy and safety are the same as those of the original brand name drugs before they are registered in Hong Kong; if not, how the authorities ensure that the generic drugs reach the efficacy and safety standards of the original brand name drugs; whether they know if the EU, Australian and Singaporean authorities have adopted the same relevant measures as those in Hong Kong?
Reply:
President,
Starting from 2002, all local pharmaceutical manufacturers have to comply with the "Good Manufacturing Practices" (GMP) set by the Pharmacy and Poisons Board. Our replies to each part of the question are as follows:
(a) Drugs produced by pharmaceutical manufacturers with GMP certificates can apply for registration for sale with the relevant authorities in the European Union (EU) or the United States (US). As far as we understand, the EU authority has not put in place a mechanism for direct recognition of GMP certificates issued by authorities of other countries or regions.
(b) The Review Committee on Regulation of Pharmaceutical Products (Review Committee), chaired by the Permanent Secretary for Food and Health (Health), was set up by the Food and Health Bureau (FHB) in March this year to undertake a comprehensive review of the existing regulatory regime for the control of pharmaceutical products, which includes, inter alia, the GMP standards required of the pharmaceutical manufacturers. A working group chaired by the Director of Health was also set up by the Department of Health (DH) to put forward proposals on the updating of the GMP scheme and on the enhancement of pharmacovigilance. The working group has commissioned an overseas expert consultant to conduct relevant study and make reference to the experience of overseas regulatory authorities. It is expected that the work of the Review Committee and the working group will be completed by the end of this year.
(c) Where a drug produced in the Mainland is to be registered in Hong Kong, documents to prove the quality of that drug have to be submitted in the registration application. Currently, the GMP certificate issued by the State Food and Drug Administration (SFDA) is a recognised document, but GMP certificates issued by provincial authorities are not regarded as recognised documents. Should there be queries on the GMP certificate submitted by the applicant, the DH would approach the SFDA for confirmation of the validity of the certificate to ensure that the registered pharmaceutical product is manufactured by a GMP manufacturer approved by the Mainland.
We do not have the relevant information on whether the EU countries, Australia, Japan and Singapore will accept GMP certificates issued by the Mainland authorities as supporting proof for applications made for drugs to be sold in these countries.
(d) From our understanding, bioequivalence tests have to be conducted for some generic drugs (i.e. non-patent drugs), in particular those with a narrow therapeutic index (i.e. there is little difference between the therapeutic dose and the poisonous dose of these drugs) if they are registered in EU countries, Australia and Singapore.
At present, bioequivalence tests are not mandatory requirements for the registration of generic drugs in Hong Kong. In accordance with the Pharmacy and Poisons Ordinance, all drugs, including generic drugs, must meet the relevant requirements regarding safety, efficacy and quality before the Pharmaceuticals Registration Committee (PRC) under the Pharmacy and Poisons Board will grant approval for their registration. To strengthen the regulation of the safety, efficacy and quality of generic drugs, the PRC has decided to introduce in phases bioequivalence tests as the requirements of registration of these generic drugs.
Ends/Wednesday, June 10, 2009
Issued at HKT 12:32
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