OTC Medicines
This article was originally published in SRA
Executive Summary
Revision of AGRD2 proceeds with supplement 4 on efficacy and safety
Revision of AGRD2 proceeds with supplement 4 on efficacy and safety
The Therapeutic Goods Administration has issued the fourth in a series of supplements revising the Australian Guidelines for the Registration of Drugs, Volume 2 (AGRD2) related to OTC medicines 1. Supplement 4: Efficacy and Safety of OTC Medicines supersedes Chapters 9 (safety) and 10 (efficacy) of AGRD2 and must be read in conjunction with other chapters of the document. Supplements 1-3 have been published previously2.
References
1. Australian Guidelines for the Registration of Drugs, Volume 2, Supplement 4: Efficacy and Safety of OTC Medicines, December 2002
2. The Regulatory Affairs Journal , 2002, 13 (6), 509