Industry
- Prescription medicines regulation basics
- Standards, guidelines & publications
- Forms for prescription medicine sponsors
- Regulatory decisions and notices
Standards, guidelines & publications
Prescription medicines
Related information
- Australian regulatory guidelines for prescription medicines (ARGPM)
These guidelines will assist sponsors to prepare applications to register new prescription or other high risk medicines for human use in Australia, or to vary existing medicine registrations - Minor variations to registered prescription medicines: Biological medicines
This document provides guidance for making minor variations to existing ARTG entries - Minor variations to registered prescription medicines: Chemical entities
This document provides guidance for making minor variations to existing ARTG entries - Streamlined submission process for prescription medicines
The streamlined submission process for the registration of new prescription medicines and major variations to existing medicines, will provide clarity of TGA requirements and predictability in timeframes - Common technical document (CTD)
The TGA only accepts applications to register prescription medicines in the Common Technical Document (CTD) format - Guidance for industry on electronic prescription medicine submission dossiers
It is a requirement that all category 1 and category 2 prescription medicine submission dossiers received at the TGA be provided in both hardcopy and electronic forms - European Union guidelines
Lists of European Union Guidelines relating to medicines, both those published as adopted in Australia and those published as not adopted in Australia. - Risk management plans for prescription medicines
A Risk Management Plan (RMP) is a set of pharmacovigilance activities and interventions designed to identify, characterise and manage risks relating to a medicine - Australian Public Assessment Report (AusPAR) guidance
Information about the structure, and processes for the compilation, review and publishing of an AusPAR - Australian pharmacovigilance requirements and recommendations for medicine sponsors
This document sets out requirements and guidance for the reporting of adverse reactions and significant safety issues for both registered and listed medicines regulated by the TGA. - Colourings permitted in medicines for oral use
List of colourings permitted in complementary, OTC and prescription medicines for oral use and provides indicative data requirements for the evaluation of new colours for inclusion in medicines for oral use - Best practice guideline on prescription medicine labelling
Guideline to guide pharmaceutical sponsors and TGA assessors in the design and review of the acceptability of prescription medicine labelling - Guideline on prescription medicine discontinuations
Ensuring best practice in the notification of prescription medical product discontinuations - Joint TGA-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance (PMS) studies
These guidelines apply to company-sponsored post-marketing surveillance studies of drug safety and toxicity - Literature-based submissions - points to consider
This document will assist sponsors in compiling a literature-based submission (LBS) - TGA approved terminology for medicines
Lists of Australian Approved terminology that ensure accuracy and consistency in the information compiled in the ARTG. For medicines, the lists cover substances (active ingredients and excipients), containers, dosage forms, routes of administration and units of expression and proportion.
Web page last updated: Tuesday, 14 May 2013
URL: http://www.tga.gov.au/industry/pm-sgp.htm