Draft regulatory model for traditional medicines released

By Staff Reporter

- Last updated on GMT

Related tags: Health care

The first public draft of a regulatory model for traditional
medicines has been unveiled by a congress of nine organisations
which believe the current regulations do not adequately provide for
continued access to and safety of products.

The Traditional Medicines (TM) Congress was formed in 2004 with the aim of "benefit[ing] public health by ensuring access to traditional medicines in a manner that provides a reasonable expectation of public safety"​.

It argues that the current regulatory framework leaves traditional medicines somewhat out on a limb, since they do not completely fit with the Federal Food, Drug and Cosmetics Act description of either 'food' or 'drug'.

While some traditional medicines may fall under the remit of the Dietary Supplements Health and Education Act, they may not be marketed as medicines.

"The current legal framework for dietary supplements provides significant options for consumer health care choices,"​ said Michael McGuffin, president of the American Herbal Products Association, one of the members of the TM Congress.

"The model proposed here would completely protect the current law while developing a new option that will benefit marketers who want to sell traditional medicines and practitioners and consumers who want to use them."

The draft document released on Monday sets out the guiding assumptions and key components of the regulatory model, including definition of traditional medicines, manufacture, safety, claims, adverse events reporting and the establishment of an advisory body.

The TM Congress is inviting comments on the draft, which may be submitted by email​ before March 31 2006. After this date, the congress will review comments and make adjustments as required.

The proposal is available online​.

Related topics: Regulation

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