Australia’s Therapeutic Goods Administration (TGA) has released guidelines for comment that revise its framework for the application and approval processes for over-the-counter (OTC) drugs. Comments are due by February 11.
The “Australian Regulatory Guidelines for Over-the-Counter Medicines” (ARGOM) is a set of documents that seeks to: ● provide information to help sponsors of OTC medicines meet their obligations under the therapeutic goods legislation ● ensure that applications to the TGA relating to OTC medicines uniformly meet all essential regulatory requirements so that applications may be processed successfully within minimum timeframes, and ● clarify processes leading to the registration and listing of OTC medicines in the Australian Register of Therapeutic Goods (ARTG).
Substantial revision of the existing published ARGOM has been undertaken in consultation with a working group composed of representatives from the TGA and the Australian pharmaceutical and cosmetics industry associations. The revision process will be divided into two stages.
The first stage of the consultation process, in progress at this time, involves five appendices released for consultation, which have been chosen on the basis that they are intended to provide sponsors with greater clarity on the data requirements for submitting effective OTC medicine applications to the TGA. The five guidelines cover OTC: ● safety and efficacy ● quality ● presentation ● applications for new substances, and ● applications for specific products.
In stage two, it is envisioned that the ARGOM chapters associated with the process and format of OTC medicine applications, as well as post-market activities, will be released for consultation once revised processes have been developed, consulted on and implemented.