Australia. TGA adopts EU guidelines CPMP/EWP/560/95/Rev. 1 Corr.* (pdf,833kb)* Guideline on the Investigation of Drug Interactions In place of: CPMP/EWP/560/95 Note for Guidance on the Investigation of Drug Interactions and EMEA/CHMP/EWP/297931/2008 Concept Paper on this topic EMA/CHMP/QWP/811210/2009-Rev1 (pdf,97kb) Guideline on Real Time Release Testing (formerly Guideline on Parametric Release) In place of: CPMP/QWP/3015/99. Note for Guidance on Parametric Release EMEA/CHMP/ICH/308671/2008 (pdf,63kb) ICH Topic Q4B Annex 4 A Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter EMEA/CHMP/ICH/308817/2008 (pdf,68kb) ICH Topic Q4B Annex 4 B Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter EMEA/CHMP/ICH/308867/2008 (pdf,59kb) ICH Topic Q4B Annex 4 C Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter EMA/CHMP/600958/2010/Corr.* (pdf,138kb) Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.7.1 TGA annotation: The procedure for abridged applications claiming essential similarity to a reference product (i.e., for generic medicines), which allows applications to be made to numerous Member States of the EU, based on bioequivalence with a reference product from one Member State, does not apply in Australia. Unless otherwise justified, an application for registration of a generic medicine in Australia should generally include one or more bioequivalence studies, each versus the Australian reference product. Directions given in this guideline regarding non-EU reference products (Section 2), and Member State where the reference product is purchased from (Table 2.1) should be disregarded in favour of the advice given in TGA Guidance 15: Biopharmaceutic studies. Similarly, details of the (presumably most recent) EU Authority Inspection of the clinical and bioanalytical study sites and site of the PK and statistical analysis (Table 2.2) are GCP/GLP issues, and need not be provided. Table 3.1 should be amended according to the metrics that are suitable for the product and/or study type. EMA/CHMP/351889/2013 (pdf,210kb) Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. EMA/CHMP/213972/2010 (pdf,105kb) Paediatric Addendum to the CHMP Guideline on the Clinical Investigations of Medicinal Products for the Treatment of Pulmonary Arterial Hypertension In place of: EMEA/CHMP/EWP/644261/2008 concept paper on this topic EMA/CHMP/325170/2012 (former CPMP/EWP/707/98 Rev. 1 corr) (pdf,227kb) Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery In place of: CPMP/EWP/707/98 Rev 1 Guideline on Clinical Investigation of Medicinal Products for Prophylaxis of High Intra- and Post-Operative Venous Thromboembolic Risk CPMP/EWP/18/01/Rev. 1 (pdf,224kb) Note for Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Urinary Incontinence In place of: CPMP/EWP/18/01 EMA/CHMP/748108/2013 (pdf,178kb) Guideline on clinical investigation of medicinal products in the treatment of lipid disorders In place of: CPMP/EWP/3020/03 Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders. EMA/CHMP/494506/2012 (pdf,124kb) EMEA/CHMP/EWP/213057/2010 Paediatric addendum to CHMP guideline on clinical investigation of medicinal products in the treatment of lipid disorders. CHMP/ICH/752211/2012 (pdf,91kb) ICH Guideline S10 on photosafety evaluation of pharmaceuticals. See also: Finalised guideline (pdf,265kb) Replaces: CPMP/SWP/398/01 Note for Guidance on Photosafety Testing, and EMA/CHMP/SWP/336670/2010 Question and answers on the Note for guidance on photosafety testing EMA/CHMP/ICH/752486/2012 (pdf,96kb) ICH guideline S1 Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals Quality of medicines Q&A TGA annotation: Answers amended after 1 August 2014 are excluded until such time as they have been considered by TGA.
Posted on: Mon, 04 Aug 2014 16:01:50 +0000