ICH

ICH

Transition for GCP Auditors in Australia from ICH GCP E6(R2) to E6(R3) and the Implications for Sponsors
ByPharmOut 23-May-202523-May-2025

The International Council for Harmonisation’s (ICH) formally adopted the ICH Good Clinical Practice (GCP) E6(R3) guideline on January 6, 2025, marking the most significant evolution in clinical trial standards in nearly a decade. This comprehensive revision introduces notable changes to sponsor responsibilities while emphasising quality management, risk-based approaches, and enhanced oversight requirements. Understanding these changes…

Read More Transition for GCP Auditors in Australia from ICH GCP E6(R2) to E6(R3) and the Implications for Sponsors
GMPs | ICH

Impending ICH Q3D elemental impurities compliance requirements?
ByTrevor 28-Jun-201701-Oct-2024

In early 2017, the United States Pharmacopeial Convention (USP), European Medicines Agency and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) finalised guidelines (ICH Q3D and USP ) containing new permitted daily exposure limits for elemental (inorganic) impurities in pharmaceuticals and dietary supplements. On the 17th of August 2015,…

Read More Impending ICH Q3D elemental impurities compliance requirements?
ICH | Medical Devices | TGA

The Medical Device Single Audit Program
ByPharmOut 21-Jan-201503-Oct-2022

In October 2013, the Therapeutic Goods Administration (TGA) announced the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the US Food and Drug Administration. On January 1, 2015, the MDSAP pilot program was opened to manufacturers around the…

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ICH | TGA

National Commission of Audit and the TGA
ByTrevor 03-May-201403-Oct-2022

The National Commission of Audit Recommendation 19 could significantly improve the cost and time to market for new drugs. The Commission cites the example of Atorvastatin, currently the most highly prescribed and highest cost to government medicine in Australia, New Zealand only pays $2.01 in comparison to the price paid in Australia of $38.69. The Commission recommends many changes are be…

Read More National Commission of Audit and the TGA
GDP and Documentation | ICH | Medical Devices | TGA

TGA signs agreement for eCTD submissions
ByPharmOut 27-Feb-201403-Oct-2022

The TGA has announced that it has signed an agreement to use the docuBridge® software solution to receive, review and process electronic applications for the entry of prescription medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).

Read More TGA signs agreement for eCTD submissions
EU and EMA | ICH | TGA

Consultations on adoption of EU guidelines in Australia
ByPharmOut 05-Jul-201303-Oct-2022

EU guidelines A number of EU guidelines have been proposed for adoption or non-adoption by the TGA. These are now open for comment until 19 August 2013. The guidelines in question are listed below: Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture. Guideline on the requirements for quality documentation…

Read More Consultations on adoption of EU guidelines in Australia
GMPs | ICH

ICH aim to become more transparent in pursuit of greater harmonization
ByPharmOut 29-Jun-201303-Oct-2022

The ICH Steering Committee and its Expert Working Groups met in Belgium in June 2013. The Steering Committee agreed measures aimed at increased transparency in pursuit of greater harmonisation and will provide more detail to the public via the ICH website, including agendas and the reports of meetings as well as the work plans of…

Read More ICH aim to become more transparent in pursuit of greater harmonization
EU and EMA | ICH

Update for Australian API and IMP manufacturers exporting to the EU
ByTrevor 01-May-201327-Oct-2022

The impact of recent changes to the “Internationally harmonised requirements for Batch Certification”? The European Union (EU) has reformed the rules for importing active pharmaceutical ingredients into the EU for medicinal products for human use. As of 2 January 2013, all imported active substances must have been manufactured in compliance with standards of good manufacturing…

Read More Update for Australian API and IMP manufacturers exporting to the EU

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