3 de setembro de 2019

TGA NEWS: New Tool to help sponsors to find information on registering prescription medicines

From: www.tga.gov.au

The Therapeutic Goods Administration (TGA) just launched today a "Beta version" of the tool Australian Regulatory Guidelines for Prescription Medicines, or 'ARGPM'.

The ARGPM is a collection of guidance documents and other information about the regulation of prescription medicines, which has been designed for use by sponsors to provide a way to search in a single location, guidance documents, forms and other resources relating to registering prescription medicines.

To use it, you can:
  • filter the list by selecting the topics, sub-topics or tags of interest in the menu; or
  • make a search using keywords.
In both ways, the results are limited to relevant items within the ARGPM. 

If it does not work, a general search on the entire website is always possible using the main site search.

All commonly used ARGPM documents, including basic information, CTD and general dossier requirements and forms, can be found at medicine registration fundamentals.

The previous version of the ARGPM will remain available for a short time, allowing TGA to continue to improve the tool in response to the user's feedback.