Pharmacy Daily | TGA launches OTC review

THE Therapeutic Goods Administration has announced the first stage of its consultation into the Australian Regulatory Guidelines for Over-the-Counter Medicines (AGROM). The consultation follows the commencement of a review by the TGA into the market authorisation process for OTC medicines which is expected to introduce revised processes for OTC medicines. The TGA said it’s hoped that the consultation will improve the AGROM in the provision of clear and useful information for its intended audience. The first stage of the process involves the release of five appendices 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 applications to the TGA. The Consultation documents include: Guidelines on safety and efficacy aspects of OTC application, Guidelines on quality aspects of OTC application, Guidelines on presentation aspects of OTC application, Guidelines on OTC application for new substances, and Guidelines on OTC application for specific products. The closing date for consultation submissions has been set by the TGA as 01 February 2012. MEANWHILE the plan for the second stage of the consultation process will see the remaining ARGOM chapters that are associated with the process and format of OTC medicine applications, as well as postmarket activities, released for consultation, once revised processes have been developed, consulted on and implemented. The TGA said submissions will be reviewed, with feedback provided online and recommendations published as outcomes.

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