Traditional and Complementary Medicine Product: A Pre-Requisite for Clinical Trial

Author

DR ZAKIAH ISMAIL
Head of Herbal Medicine Research Centre (HMRC)
Institute for Medical Research
Ministry of Health Malaysia
Email:
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Language

English

Title

Traditional and Complementary Medicine Product:  A Pre-Requisite for Clinical Trial

Proceeding

7th INTRACOM – 2nd ICBWI 2009

Date

25th July 2009

Place Held

PWTC, Kuala Lumpur

Abstract

Traditional and complementary medicines market trend has been continuously on the rise with significant contribution to the economy. Locally more than 10,000 products have been registered to the Ministry of Health as traditional medicine. However, although registered, products are only allow for treating the common ailments unless they are proven effective for treating diseases after going through proper clinical trails. Pre-clinical toxicology has been one of the important requirements before any product could go for clinical trail.As a new member of Mutual Acceptance Data (MAD) Country of the Organisation of Economic Co-operation and Development (OECD), pre-clinical toxicology conducted in Malaysia has to follow a Good Laboratory Practice (GLP) standards as stipulated by OECD. The main aim of compliance to GLP is to ensure the quality of data obtained from the laboratory of a country, hence other countries of OECD members could mutually accept it and this agreement prevent duplication of such testing. In order for GLP to be in place, its 10 elements which include testing facility beside the methodology and investigator should be met. T&CM product, identified as test article in the GLP element 6, will need to have certain specification and handling procedure and this will be further elaborated in the paper . The other 9 elements of GLP will also be explained.

Keywords

Traditional and Complementary medicine, Good Laboratory Practice, Mutual Acceptance Data

Session

Symposium 4A-3

Topic

Quality and Safety of TCM Products