TGA Database Publishes Listed Medicine Compliance Review Results

To monitor the safety, quality and efficacy of listed medicines and ensure they meet all requirements once they are on the market, the TGA conducts listed medicine compliance reviews on a proportion of those on the Australian Register of Therapeutic Goods (ARTG). This database makes information publicly available about the results of TGA's compliance reviews of individual listed medicines. Publication of results only occurs once the compliance review has been concluded, after the sponsor has had the opportunity to consider our findings and actions have been undertaken to address any identified issues and the results are released quarterly.    Source: LM reviews  (Please see also: Compliance Actions and Outcomes)

‘Health Products Regulation Group’ Details Regulatory Science Strategy for Next Five Years

The HPRG comprises the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC). Regulatory scientists in HPRG use highly developed knowledge and skills from a range of disciplines to make, or contribute to, risk-managed and evidence-based decisions about health products. This document outlines a strategy for how HPRG will maintain and build regulatory science capability over the next five years. It identifies ways to make sure that they continue to make the best possible decisions, and that they are prepared for future regulatory challenges. This will help meet the vision of better health and wellbeing for all Australians through regulatory excellence.     Source: HPRG 5 year strategy

Increased Online Access to Ingredient Information Following TGA Response to Consultation

Throughout 2019, the TGA sought feedback from interested parties on a proposal to increase access to ingredient information. It was proposed to publish the names of excipient (or 'inactive') ingredients in the public view of therapeutic goods on the Australian Register for Therapeutic Goods (ARTG). All submissions and survey responses that were not marked as confidential are available here: TGA consultation responses

Outcomes of the Lower Risk Registered Over-the-Counter (OTC) Products Review Pilot Project

A Lower Risk OTC Products Review pilot project was developed in response to recommendation 14 of the Medicines and Medical Device Regulation Review (MMDR) where the TGA examined whether the regulations and restrictions in place for various ‘low risk’ registered therapeutic goods are still appropriate. This recommendation related to several different types of therapeutic goods, including registered OTC medicines. The TGA undertook to review classes of registered OTC medicines, that have a higher amount of regulation applied to them, to assess whether they may be suitable for becoming listed medicines (listed medicines have less strict regulatory guidelines applied to them). A pilot project was proposed to provide further clarity on the resource requirements, limitations and impacts on medicine sponsors as well as to address additional issues raised by industry during the consultation. 'Antimicrobial throat lozenges' were identified as the medicine group to be considered for the pilot project and the results may be read here: OTC pilot project

Consultation: Adoption of European Union guidelines in Australia

The TGA confers with other overseas regulators in order ensure, where possible, maximal regulatory conformity.  Currently, the TGA is conducting a consultation to determine whether it will adopt a range of guidance systems used by the EU. In Australia, the listed medicine system is not monograph based, however the proposed guidance may be relevant to new substance applications, listed assessed medicines or registered medicines, as these application types may use EU monographs as supportive documentation. Consultation closes 7 February 2020.    Source: EU guidelines consultation

Consultation: Proposed Amendments to the Poisons Standard

Substances which may be of interest include: Arbutin (α and β); Picramic acid (new item); and, marker dyes or pigments (new interpretation). This consultation closes on 10 February 2020.    Source: SUSMP consultation

 

  


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Robert Forbes - Director
robert@robert-forbes.com
+61 2 9660 8027

Ellie Kim - Regulatory Affairs Manager
ellie@robert-forbes.com
+61 450 533 129

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