Replies to LegCo questions
LCQ11: Regulation of Pharmaceutical Products
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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