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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.
Filters
Topics
- Registration basics (6) Apply Registration basics filter
- Registration pathways (34) Apply Registration pathways filter
- Submission information and guidance (36) Apply Submission information and guidance filter
- Dossier and eCTD guidance (14) Apply Dossier and eCTD guidance filter
- Data requirements (20) Apply Data requirements filter
- GMP guidance (4) Apply GMP guidance filter
- Product Information, labelling and packaging (18) Apply Product Information, labelling and packaging filter
- Varying an ARTG entry (26) Apply Varying an ARTG entry filter
- Post-market requirements and activities (20) Apply Post-market requirements and activities filter