A review committee has proposed establishing a dedicated office to plan and direct the implementation of drug-safety measures, boosting the Government's regulatory role in enhancing drug safety. It could be expanded into the "Centre for Drug Safety" in the long term.

The proposal is among the 75 recommendations the Review Committee on the Regulation of Pharmaceutical Products forwarded to the Government to enhance the regulatory regime of drug products from manufacturing to retailing, after a nine-month study.

Unveiling the report today, Secretary for Food & Health Dr York Chow said the recommendations will help raise drug-industry standards, ensure patient safety and protect public health.

The committee considered the framework and rationale behind the existing regime sound; however, it felt the regulatory measures' coverage and depth should be enhanced. At the same time, the pharmaceutical sector plays a pivotal role in protecting the system's integrity by observing self-discipline and upholding pharmacists' professional standards.

The committee recommended the Department of Health establish 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 drug information to the public.

Other recommendations

Other major proposals include:

* upgrading the Good Manufacturing Practices standard to a higher international standard and introducing microbiological monitoring for non-sterile drugs during the manufacturing process;

* implementing a code of practice for wholesalers, importers and exporters, and strengthening the tracking system for drugs imported for re-export;

* increasing the required number of years of industrial experience and enhancing training to tighten the qualification requirements of 'authorised persons' working for drug manufacturers;

* all companies undertaking repackaging activities to have a manufacturing licence;

* replacing the term "poison" with alternatives like "prescription drugs" and "drugs under supervised sale" on drug labels;

* the Department of Health shortening the processing time for drug-registration approval;

* requiring wholesalers to keep transaction records for all pharmaceutical products, including Part II poisons and non-poisons;

* wholesalers and retailers handling non-poisons should apply for a licence. A registered pharmacist will have to be present whenever a pharmacy is open for business;

* empowering the Pharmacy & Poisons Board to revoke licences of Authorised Sellers of Poisons, and requiring retailers and doctors to have written records for drug orders to prevent errors during delivery of drugs; and,

* requiring drug suppliers to the department and Hospital Authority to provide detailed information such as pack size and registration number on delivery documentation.