Further to CMA's 6 February 2024 tech alert on the TGA's proposal to adopt certain international scientific guidelines in Australia, this alert is updated to include further information on the relevance of 11 of the 13 proposed international scientific guidelines to some Listed, Listed Assessed and Registered Complementary Medicines, and some New Substance (or changed substance) applications. Updates are included in green highlights.

Residual Solvents

Raw Material Suppliers, Sponsors and Manufacturers should review the following information. 

All Listed Medicines that are subject to the TGO 101 (tablets, capsules and pills) will need to apply the ICH Q3C as it is incorporated in Ph. Eur. 5.4 referred to in Section 16(2) of the TGO 101.

As noted in this alert, CMA has included a comparison of the current Q3C (R6) and the proposed Q3C (R8) documents. The changes predominantly relate to:

- The removal of methyltetrahydrofuran from Table 4. -  Solvents for which no adequate toxicological data was found.

- The addition of Part VI: PDE for 2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tertiary-Butyl Alcohol (pp 41-51).   

- Cyclopentyl Methyl Ether: 15.0 PDE (mg/day); 1500PPM

- Tertiary-Butyl Alcohol: 35 PDE (mg/day); 3500PPM

- 2-Methyltetrahydrofuran 50 PDE (mg/day).

Members are encouraged to review the information in this tech alert  and the guidelines to determine suitability to complementary medicines within Australia and provide any relevant comment to CMA by 28 Feb and/or through the TGA public consultation survey, which closes 4 March 2024. 

Please read today’s update  for more details.