Press Releases
Pharmaceutical products review committee makes recommendations
The Review Committee on the Regulation of Pharmaceutical Products in Hong
Kong, which is tasked to strengthen the regulatory regime of pharmaceutical
products, has put forward 75 recommendations to the Government after a
nine-month study.
These recommendations cover improvements in areas from manufacturing to
retailing so that a high safety standard can be attained at all levels.
The review committee was set up last March following a series of incidents
concerning pharmaceutical products in Hong Kong in early 2009 causing public
concern about the safety of drugs manufactured locally. Chaired by the
Permanent Secretary for Food and Health (Health), Ms Sandra Lee, the review
committee has a broad representation of members from the pharmaceutical
sector, the medical profession, academia, patients groups and consumer
representatives.
The committee convened its first meeting in April to undertake a
comprehensive review of the existing regulatory regime for the regulation
and control of pharmaceutical products.
The full report of the committee's study was recently completed and
submitted to the Secretary for Food and Health, Dr York Chow. The report
will also be sent to the Legislative Council Panel on Health Services for
its meeting on January 11, 2010.
Unveiling the full report today (January 5), Dr Chow expressed his gratitude
to the members of the review committee, including the pharmaceutical and
medical sectors, academia, patients groups and consumer representatives for
their invaluable advice and unfailing support during the whole course of the
review.
"The work and recommendations of the review committee help raise the
standards of the pharmaceutical industry and enhance the regulation of
pharmaceutical products," Dr Chow said.
"This will ensure patient safety and protect public health," he added.
The review committee considers that the framework and the rationale behind
the existing regime is sound and while it should continue to be adopted, the
coverage and depth of the regulatory measures should be enhanced. At the
same time, the review committee believes that the pharmaceutical sector
plays a pivotal role in protecting the integrity of the system by observing
self-discipline and upholding the professional standards of pharmacists.
The recommendations made by the review committee cover all aspects relating
to the supply of drugs, Ms Sandra Lee said.
On the regulation of drug manufacturers and the Good Manufacturing Practices
(GMP) Scheme, the review committee recommends upgrading the current Hong
Kong GMP standard to a higher international standard and the introduction of
microbiological monitoring for non-sterile drugs during the manufacturing
process.
The review committee also recommends increasing the required number of years
of industrial experience and enhancing training so as to tighten the
qualification requirements of the authorised persons by the drug
manufacturers.
It also recommends requiring all companies which undertake repackaging
activities to have a manufacturing licence.
On the pre-market control of drugs, the review committee recommends
replacing the term "poison" with alternative terms such as "prescription
drugs" and "drugs under supervised sale" on drug labels. The review
committee also recommends that the Department of Health (DH) shortens the
processing time for drug registration approval.
On the regulation of importers/exporters, wholesalers and retailers, the
review committee recommends requiring wholesalers handling non-poisons to
apply for a licence. It also recommends requiring wholesalers to keep
transaction records for all pharmaceutical products, including Part II
poisons and non-poisons.
The review committee also recommends a Code of Practice for wholesalers,
importers and exporters and strengthening of the tracking system for drugs
imported for re-export.
In addition, the review committee recommends that retailers handling
non-poisons be required to apply for a licence. In the long run, a
registered pharmacist will have to be present whenever a pharmacy is open
for business.
The review committee also recommends empowering the Pharmacy and Poisons
Board to revoke licences of Authorised Sellers of Poisons. It also suggests
retailers and doctors be required to have written records for drug orders to
prevent errors during delivery of drugs.
Regarding the procurement and supply of pharmaceutical products in the
public and private medical sectors, the review committee recommends that the
Hospital Authority (HA) and DH require suppliers to provide detailed
information such as pack size and registration number on the delivery
documentation. The HA and DH should also step up the quality checks of drugs
and encourage the private medical sector to follow the proposed set of
guiding principles on drug handling.
On post-market control of drugs, the review committee recommends that the DH
maintain rigorous surveillance of high-risk products and enhance
pharmacovigilance activities.
The review committee also recommends that the DH set up a dedicated team to
co-ordinate efforts in drawing up guidelines on risk communication,
performing risk assessment in response to incidents, recommending risk
communication actions and providing more information on drugs to members of
the public.
The review committee also suggests strengthening penalties for people who
violate the regulations.
Furthermore, the review committee recommends that a dedicated office on
drugs should be set up to strengthen the regulatory role of the Government
in enhancing drug safety. The office will plan and direct the implementation
of measures relating to drug safety. In the long run, consideration will be
given to expanding the office to be a "Centre for Drug Safety".
"The review committee has completed its task by recommending measures to
improve the existing regime. The Government will take follow up actions to
implement these measures," a spokesman for the Food and Health Bureau said.
"The Food and Health Bureau will oversee the policy issues, and together
with DH, will take forward the necessary legislative amendments, address the
resource implications and requirements involved," the spokesman added.
Ends/Tuesday, January 5, 2010
Issued at HKT 12:10
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