USFDA:
Guidances (Drugs) - Food and Drug Administration
US FDA Title 21 CFR Parts
PART 11 |
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PART 58 |
GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES22 |
PART 110 |
CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD |
PART 111 |
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PART 210 |
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PART 211 |
CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS22 |
PART 600 |
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PART 601 |
LICENSING BIOLOGICS |
PART 606 |
CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS |
PART 610 |
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PART 700 |
GENERAL COSMETICS |
PART 701 |
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PART 820 |
QUALITY SYSTEM REGULATION MEDICAL DEVICES |
EU
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EMA GMP Guidelines
- Quality guidelines
- Quality of medicines questions and answers: Introduction
- Biological guidelines
- Non-clinical guidelines
- Clinical efficacy and safety guidelines
- Multidisciplinary guidelines
WHO
WHO | Norms, standards and guidance for pharmaceuticals
Biologicals: WHO | Publications and links
WHO Working Documents (Draft Documents)
ICH Guidelines
Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
Zip with all ICH Quality Guidelines in word format
ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.
Zip file with all ICH Safety Guidelines in Word format
The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to produce better targeted medicines.
Zip file with all Efficacy Guidelines in Word format
Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
Zip file with all Multidisciplinary Guidelines in Word format
Health Canada