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Drugs and Health Products
Draft Guidelines Out for Comment
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- Revised Draft Guidance Document Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format [2011-08-08]
- Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Q11: Development and Manufacture of Drug Substance [2011-07-07]
- Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 14 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on: Bacterial Endotoxins Test General Chapter [2010-08-17]
- Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 13 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on: Bulk Density and Tapped Density of Powders General Chapter [2010-08-17]
- Consultation- Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals [2009-12-07]
- Notice - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E16: Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions [2009-08-24]
- E2F - Notice - Release of Draft (Step 2) ICH Guidance: Development Safety Update Report [2008-08-27]
