International Conference on Harmonisation
Label
International Conference on Harmonisation
Name
International Conference on Harmonisation
Actions
Incoming Resources
- Guidance for industry, M4, the CTD, general questions and answers
- Guidance for industry, Q1A(R2) stability testing of new drug substances and products
- Guidance for industry, Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter
- Guidance for industry, E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
- Guidance for industry, S2B genotoxicity, a standard battery for genotoxicity testing of pharmaceuticals
- Guidance for industry, Q8(R2) pharmaceutical development
- Studies in support of special populations, geriatrics
- Dose-response information to support drug registration
- Guidance for industry, M2 eCTD : electronic common technical document specification
- Guidance for industry, M4Q, the CTD, quality
- Guidance for industry, Q1E evaluation of stability data
- Guidance for industry, granularity document : annex to M4, organization of the CTD
- Guidance for industry, M3 nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals
- Guidance for industry, M4S, the CTD, safety
- Guidance for industry, Q3A impurities in new drug substances
- Guideline for industry, detection of toxicity to reproduction for medicinal products, addendum on toxicity to male fertility
- S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use
- Guidance for industry, E 10 choice of control group and related issues in clinical trials
- Guidance for industry, E2BM data elements for transmission of individual case safety reports
- Guidance for industry, Q3B(R2) impurities in new drug products
- Guidance for industry, Q6B specifications : test procedures and acceptance criteria for biotechnological /biological products
- Guidance for industry, E 11 clinical investigation of medicinal products in the pediatric population
- Guidance for industry, Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
- Guidance for industry, Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 2 test for extractable volume of parenteral preparations general chapter
- Guidance for industry, Q1D bracketing and matrixing designs for stability testing of new drug substances and products
- Guidance for industry, E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories
- Guidance for industry, E2E pharmacovigilance planning
- Guidance for industry, Q7A good manufacturing practice guidance for active pharmaceutical ingredients
- Quality of biotechnological products, analysis of the expression construct in cells used for production of r-DNA derived protein products
- Guidance for industry M2, eCTD specification : questions & answers and change requests
- Guidance for industry, E6 good clinical practice, consolidated guidance
- Guidance for industry, Q1B photostability testing of new drug substances and products
- Q4B, annex 2, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- Guidance for industry, Q2B validation of analytical procedures, methodology
- Guidance for industry, S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions, annex 10, polyacrylamide gel electrophoresis general chapter
- Clinical safety data management, definitions and standards for expedited reporting
- Guidance for industry, addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs
- Guidance for industry, M4E, the CTD, efficacy
- Guidance for industry, M2, eCTD specification, questions & answers and change requests
- Guidance for industry, Q8 pharceutical development
- Revision of the ICH guideline on clinical safety data management, data elements for transmission of individual case safety reports
- Guidance for industry, Q3C impurities, residual solvents
- Guidance for industry, S7A safety pharmacology studies for human pharmaceuticals
- Detection of toxicity to reproduction for medicinal products
- Guidance for industry, Q1C stability testing for new dosage forms
- Guidance for industry, E2B(M), data elements for transmission of individual case study reports, questions and answers
- Guidance for industry, E 10 choice of control group and related issues in clinical trials
- Guidance for industry, Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions
- Toxicokinetics, the assessment of systemic exposures in toxicity studies
- Creator of4
- Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter
- S9 nonclinical evaluation for anticancer pharmaceuticals
- Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Dissolution Test General Chapter
- Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Uniformity of Dosage Units, General Chapter
- Focus of1