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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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