TGA Australia Updates Regulatory Guidelines In Replacement of ARGCM V8.0

The Therapeutic Goods Administration (TGA) of Australia has published in May 2020, new guidelines to replace the existing Australian Regulatory Guidelines for Complementary Medicines (ARGCM) V8.0 for registered complementary medicines and listed medicines.

The information that was published formerly on ARGCM V8.0 such as the legislation and requirements for listed medicines and registered complementary medicines and medicine interface issues were included in the latest version.

In addition, TGA has also published vital information on analytical procedure validation for complementary medicines, TGA approved terminology for medicines, and colourings used in medicines for topical and oral use.
Among the information that is classified in separate documents and listed are guidelines for herbal materials and extract, international guidelines adopted by the TGA, guidelines for sunscreen therapeutic products, guidelines for specific to listed medicines, guidelines for both listed and assessed listed medicines and guidelines specific to registered complementary medicines.

The document that replaces the previous publication is a guideline for sponsors on changing information in the ARTG for a listed or assessed listed medicine. This entails information for regulatory processes that need to be abided with, the guidance documents, and whether prior approval is essential.
The sponsors can also benefit from the Listed and Assessed Listed Medicines Change Tables to obtain essential regulatory information on the change.

The new version classifies documents separately to enable timely updates and is a reflection of the reforms made to the regulatory framework.

Kindly refer to https://www.tga.gov.au/publication/australian-regulatory-guidelines-listed-medicines-and-registered-complementary-medicines for more information