Australia’s Therapeutic Goods Administration (TGA) is requesting comment on its proposed adoption of several EU and ICH guidelines, and “non-adoption” of one. The comment period closes on November 9.
The following guidelines are proposed for adoption:
● ICH Topic Q3C (R4) Impurities: Guideline for Residual Solvents
● ICH Guideline Q4B Annex 12 to Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving – General Chapter
● ICH Guideline Q4B Annex 11 to Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis – General Chapter
● Guideline on Non-clinical and Clinical Development of Similar Biological Medicinal Products Containing Recombinant Erythropoietins
● Guideline on Quality, Non-clinical and Clinical Aspects of Live Recombinant Viral Vectored Vaccines
● Questions & Answers on the Guideline on the Limits of Genotoxic impurities
● Questions and Answers on the Withdrawal of the Note for Guidance on Single Dose Toxicity
● Guideline on Missing Data in Confirmatory Clinical Trials
● Reflection Paper on In-vitro Cultured Chondrocyte Containing Products for Cartilage Repair of the Knee
● Guideline on the Clinical Evaluation of Antifungal Agents for the Treatment and Prophylaxis of Invasive Fungal Disease
● Reflection Paper on Non-clinical Evaluation of Drug-induced Liver Injury (DILI)
● Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials
● Questions & Answers: Positions on Specific Questions Addressed to the EWP Therapeutic Subgroup on Pharmacokinetics
● Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
● Addendum to the Guideline on Antiarrhythmics on Atrial Fibrillation and Atrial Flutter
Proposed for “non-adoption:”
● ICH Topic E7 Studies in Support of Special Populations: Geriatrics. Questions & Answers
Comment instructions and document details are available on the TGA website.
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