You are here
Australian Regulatory Guidelines for Prescription Medicines (ARGPM) BETA
The ARGPM is a collection of guidance documents and other information about the regulation of prescription medicines. The ARGPM has been designed for use by sponsors to provide a way to search for relevant TGA guidance documents about prescription medicines from a single location. Commonly used ARGPM documents, including basic information, CTD and general dossier requirements and forms, can be found at medicine registration fundamentals.
This is a beta version of the new ARGPM and we welcome your feedback while the new tool is being tested. The previous version of the ARGPM will remain available for a short time.
To use the ARGPM, filter the list of documents by selecting topics, sub-topics or tags, or search using keywords. The search or filtered results are limited to relevant items within the ARGPM. If you cannot find the document you are looking for you can search the entire website using the main site search.
2 September 2019
Ingredients in therapeutic goods
Further information about the types and naming of ingredients and proprietary ingredients in therapeutic goods has recently been published by the TGA
10 July 2019
Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data
The variations guidance provides information about how to make variations to existing ARTG entries for prescription medicines
8 February 2019
Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances
Amendments to the Therapeutic Goods Regulations 1990 came into effect in late November 2018 that allow discretion to reduce application and evaluation fees for a major variation application in exceptional circumstances
29 November 2018
Boxed Warning guidance
The Boxed Warning guidance assists sponsors to understand their obligations and prescribers to understand the rationale for the warning and the magnitude of risk