Advisory committee calls for regulations on drugs production

Thursday, May 7, 2009
Issue 694, Page 2
Word count: 334
Published in: Macau Daily Times

By Poyi (Natalie) Leung

The Central District Advisory Committee for Community Services suggested the introduction of an international manufacturing and quality control system for pharmaceutical products in order to safeguard local residents’ health.

According to member Ng Pek Shan during the advisory committee meeting yesterday, Macau’s current drug regulatory system was “lagging behind” local social development.

“The government should learn from the experience in neighbouring regions and enhance the regulations instead of having make-up measures when someone dies,” she said.

Early this year some drugs produced by more than one pharmaceutical manufacturer in Hong Kong were found to have been contaminated which led to the death of hospital patients.

Although the drug manufacturers had obtained certificates of GMP – “Good Manufacturing Practice” – from the Hong Kong Department of Health, Ng said the incident showed that “fatal contamination problem” could still exist.

GMP is a set of system that is being recognised worldwide for the control and management of manufacturing and quality control testing of foods, pharmaceutical products and medical services.

However, Ng pointed out that local pharmaceutical manufacturers were not obligated to obtain GMP recognition.

The Health Bureau is currently preparing the legislation of GMP which was one of the issues being listed in the 2009 Policy Address.

Ng pressed for the enforcement of the system in Macau in a bid to ensure basic safety and reliability of locally produced pharmaceutical products.

In addition, she said that inspections by health authorities should expand to hospitals besides drug factories, as hospitals also produced in-house medicine such as commonly-used syrup, capsules and tablets for both inpatients and outpatients.

Local doctors nowadays are not necessary to tell patients about the side effects of prescription drugs.

Ng also said that names, batch numbers and expiry date of the medicine usually were not being written on packages given out by especially private clinics.

Hence, she called for local medical practitioners to follow the Health Bureau No. 3/2005 technical guideline so as to protect the public right to know and personal medication safety.

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