WHO Drug Information Vol. 19, No. 3, 2005
(2005; 72 pages) View the PDF document
Table of Contents
Open this folder and view contentsPersonal Perspectives
Open this folder and view contentsSafety and Efficacy Issues
Close this folderHerbal Medicines
View the documentMonograph for cultivation of herbal antimalarial: Artemisia annua
View the documentAyurvedic medicines and heavy metals
View the documentNational policy on regulation of herbal medicines
View the documentRegulatory guidelines for complementary medicines
Open this folder and view contentsRegulatory Action and News
Open this folder and view contentsEssential Medicines
Open this folder and view contentsAccess to Medicines
Open this folder and view contentsThe International Pharmacopoeia
View the documentRecommended International Nonproprietary Names: List 54
 

Regulatory guidelines for complementary medicines

Australia - In May 2003, the Australian Government established the Expert Committee on Complementary Medicines to review regulatory, health system and industry structures. The committee made 49 recommendations on a range of issues, including that a communication strategy be developed to better inform consumers of the potential risks associated with the personal importation of complementary medicines that may not be manufactured to the same standards of medicines available in Australia.

Australian Regulatory Guidelines for Complementary Medicines (ARGCM) have now been published with the aim to:

• provide information to help sponsors of complementary medicines to meet their obligations under therapeutic goods legislation;

• help ensure that applications to the TGA relating to complementary medicines uniformly meet all essential regulatory requirements so that applications may be processed successfully within minimum timeframes; and

• enhance clarity and transparency of processes leading to the Registration and Listing of complementary medicines in the Australian Register of Therapeutic Goods (ARTG).


Reference: http://www.tga.au/

 

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Last updated: April 24, 2012