Surveillance of Traditional Products

Author

MADAM TAN LIE SIE
Head of Centre for Post Registration
National Pharmaceutical Control Bureau
Ministry of Health Malaysia
Email:
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Language

English

Title

Surveillance of Traditional Products

Proceeding

7th INTRACOM – 2nd ICBWI 2009

Date

25th July 2009

Place Held

PWTC, Kuala Lumpur

Abstract

The National Pharmaceutical Control Bureau carries out a continuous Post Market Surveillance Programme to monitor the quality of registered products that are placed on the market. This surveillance is conducted through routine product sampling and testing, investigation of product complaints, media surveillance, intelligence and information from other regulatory agencies. The objective is to ensure that all marketed registered medicinal products, including traditional products, meet the standards and registration conditions stipulated by the Drug Control Authority (DCA).

Although traditional products are evaluated for safety and quality prior to registration, post registration surveillance still needs to be conducted. This is to ensure compliance to pre-determined standards, approved indications, packaging and labeling requirements when the products are commercialized An overview of the Post Market Surveillance system that is in place and the results of laboratory testing and label monitoring that had been conducted on traditional products over the five (5) year period of 2004-2008 will be presented. The number of traditional products that have tested positive for adulteration has increased over the years. Unsafe products will be removed from the market. If a product is found to contain adulterants, the DCA can take punitive action including deregistration, total product recall, revocation of manufacturing licence, and instituting court action through the Pharmacy Enforcement Division. The marketing authorization holder is responsible for conducting recalls of defective or unsafe products.

Keywords

Traditional Product, market surveillance

Session

Symposium 4A-2

Topic

Quality and Safety of TCM Products