Press Releases

Drugs Review Committee endorses recommendations on enhancing drug safety

The Review Committee on Regulation of Pharmaceutical Products in Hong Kong announced today (October 23) a number of recommendations to enhance the regulatory regime of pharmaceutical products in Hong Kong.

These recommendations were endorsed by the Review Committee at a meeting yesterday.

The Permanent Secretary for Food and Health and the committee chairman, Ms Sandra Lee, said: "After six months of active and constructive discussions, the Review Committee has come up with a range of recommendations which would enhance drug safety, better protect patients and consumers and promote public health.

"With these key principles in mind, the Committee conducted the review covering all aspects of the drug regulatory regime and the supply chain of pharmaceutical products, from manufacturing, distribution, procurement, supply of drugs and delivery to the public and private sectors, to control of pharmaceutical products, pharmacovigilance as well as risk communication, education and training.

"At the same time, a risk-based approach is adopted to assess the risks in terms of the nature of the pharmaceutical products and the potential level of harm of these products.

"An enhanced inspection and audit system for the supply chain is also proposed. The trade and professionals will also need to fulfil their responsibilities to ensure drug safety," Ms Lee said.

The recommendations that the Review Committee has covered are:

(1) Entire supply chain of pharmaceutical products

(a) Manufacturers:

* To upgrade the current standards of Good Manufacturing Practices (GMP) of manufacturers to international standards.

* To introduce microbiological monitoring for non-sterile drugs during the manufacturing process.

* To tighten up the qualification of the Authorised Person (AP) by increasing the required number of years of industrial experience and imposing requirements on training. A formal set of criteria regarding the qualifications of the AP will be set, along with the introduction of a structured training programme and a mechanism to ensure that APs will take responsibility for the quality, safety and efficacy of their drug products. In the meantime, the position of AP will still be required to be filled by a pharmacist with relevant experience. In the long run when additional formal certified GMP training has been developed, consideration will be given to allowing non-pharmacists with the required experience and training to assume the position of AP.

* To require all companies which undertake repackaging activities, including secondary repackaging in addition to primary repackaging, to have a manufacturing licence. A new category of repackaging licence will be introduced for such purpose.

(b) Wholesalers

* To impose licensing control on wholesalers of non poisons in addition to the existing licence for wholesalers selling poisons.

* To tighten the control of wholesalers in terms of licensing conditions, code of practice, record keeping requirements and enhancement of inspections by the Department of Health (DH).

(c) Importers and Exporters

* To strengthen the control of the import and export of pharmaceutical products by deploying a designated team to provide advice to the Customs and Excise Department at ports of entry and to undertake surveillance work.

(d) Retailers

* To impose licensing control on retailers of non-poisons in addition to the existing licensing control on retailers of poisons.

* As an ultimate objective, to require the presence of a registered pharmacist whenever the pharmacy is open for business.

* To require retailers and doctors to have written records for drug orders. This is to ensure that there is a proper record and checking mechanism to prevent errors during delivery of drugs, which is necessary to protect the safety of patients.

(2) Procurement and supply of drugs in the public and private sector

* The Hospital Authority (HA) and DH to require suppliers to provide detailed information on the delivery documentation to enable more effective checking. They will conduct post-delivery surveillance including microbiological and chemical testing.

* DH to encourage the private medical sector to follow the proposed set of guiding principles to be issued by DH on drug procurement.

(3) Enhance the control of pharmaceutical products before and after their introduction to the market

* DH to require bioavailability and bioequivalence studies for drug registration.

* DH to shorten the processing time for drug registration approval.

* DH to continue the extended coverage for the surveillance of high risk products in the market.

(4) Pharmacovigilance

*Pharmacovigilance activity, that is detection, assessment, understanding and prevention of adverse effects of drugs, to be enhanced through education, training and promotion among healthcare professionals and the trade and to foster a culture of awareness of pharmacovigilance.

(5) Risk communication, education and training

* DH to liaise with the pharmacy profession and the tertiary education institutions on training of professionals and members of the trade.

* DH to provide more information on registered drugs to the general public, healthcare professionals and the drug industry, and to revamp its website to include more information and to be more user-friendly.

The Review Committee will consider the issue of import and re-export of drugs which are not intended for sale in the Hong Kong market. As these drugs are not required to obtain registration in Hong Kong, it is therefore important to ensure that they will not penetrate the Hong Kong market. It is crucial to establish a mechanism to enhance the traceability of these drugs after they enter Hong Kong.

"I fully appreciate the time and efforts which members have devoted to the committee��s work in the last few months. They have attached considerable importance to safeguarding patient safety and promoting public health," Ms Lee said.

The Review Committee will start to prepare its final report on the detailed recommendations which will be completed at the end of this year.

Set up on March 24, the Review Committee on Regulation of Pharmaceutical Products in Hong Kong is tasked to undertake a comprehensive review of the existing regulatory regime for the regulation and control of pharmaceutical products in the light of the drug incidents in early 2009. It consists of members from the pharmacy profession who are engaged in different aspects of the pharmaceutical sector, the medical profession, patients groups, the Consumer Council, the Hospital Authority and private hospitals.


Ends/Friday, October 23, 2009
Issued at HKT 13:10

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