Press Releases
Review Committee agrees to enhance drug safety (with photo)
The Review Committee on Regulation of Pharmaceutical Products in Hong Kong
convened its first meeting today (April 3).
Welcoming members to the Review Committee, the Secretary for Food and
Health, Dr York Chow, said it was of paramount importance for the review to
be comprehensive with the aim of raising the standards of the pharmaceutical
industry and enhancing the regulation of pharmaceutical products.
"This would ensure patient safety and protect public health," Dr Chow said.
"I am also pleased to note that Members unanimously agreed to join efforts
to enhance drug safety, so as to raise public confidence on the usage of
drugs and safeguard the reputation of Hong Kong in drug manufacturing and
sales.
"The pharmaceutical industry and the pharmacy profession should turn crisis
into opportunity to further enhance professional standards and promote
partnership and teamwork," Dr Chow added.
He has great faith in the Committee of charting a clear course for the
industry to excel.
The Review Committee is chaired by the Permanent Secretary for Food and
Health (Health), Ms Sandra Lee. It has broad representation, comprising
members from the pharmaceutical sector, medical profession, academia,
patient groups and consumer representatives, among others (please see
membership at Annex A).
Members agreed that the pharmaceutical industry has a responsibility and an
important role to play to ensure drug safety, while the regulatory regime
should, in consultation with the trade, set the standards for quality
assurance, backed by effective enforcement.
The meeting adopted the terms of reference (please see Annex B) of the
committee which formed the basis of the review in the next six to nine
months.
To facilitate in-depth examination of the range of issues, members agreed to
form two subcommittees on drug manufacturing; and drug distribution and
procurement respectively.
"Major issues to be considered by the two subcommittees include the updating
of the Good Manufacturing Practice (GMP) scheme, enhancement of
pharmacovigilance in drug manufacturing, strengthening of the pharmaceutical
sector��s governance and internal audit system, regulatory control of the
drug distribution, updating of the licensing requirements and penalty
system, procurement and supply of drugs in public and private healthcare
sectors, and training and education of those in the trade," said Ms Lee.
The Review Committee has agreed on a work plan and will come up with
recommendations at the end of this year.
At today's meeting, members also agreed that the Task Force chaired by the
Director of Health would make proposals on the updating of the GMP scheme
and on the enhancement of pharmacovigilance in Hong Kong. They welcomed the
engagement of an overseas expert consultant to review the existing GMP
scheme and to make reference to the experience of overseas regulatory
authorities.
The Review Committee supported the measures taken by the Department of
Health (DH) immediately after the incidents. These include the completion of
a round of inspections to all the 25 local manufacturers, and the ongoing
enhanced actions to -
(a) conduct surprise inspections on manufacturers, wholesalers and retailers
to ensure compliance with the legal and licensing requirements;
(b) provide more training opportunities for both managerial and front line
personnel of the pharmaceutical trade to remind them of the required
standards, the legal and licensing requirements, and the best practices.
Training courses will be organized in collaboration with academia, training
institutions and relevant professional bodies;
(c) establish a dedicated team in DH for handling drug incident reporting
from medical practitioners, pharmacists and the trade; and
(d) promote drug safety among the trade, healthcare providers and consumers.
DH is recruiting an additional ten pharmacists in the short term to meet the
increased workload. The Government will consider the need for additional
manpower for DH in the course of the review.
Members also noted the seven measures taken by the Hospital Authority to
enhance it procurement system, which focuses on quality control, checking of
delivery and storage, risk management and enhancement of drug quality
assurance team.
Set up on March 24, the Review Committee on Regulation of Pharmaceutical
Products in Hong Kong was tasked to undertake a comprehensive review of the
existing regulatory regime for the regulation and control of pharmaceutical
products in the light of the recent drug incidents.
Ends/Friday, April 3, 2009
Issued at HKT 19:00
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(Photo)