ICH (InternationalConference on Harmonization) Guidelines

The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories.

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.

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.

Efficacy Guidelines

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/genomics techniques to produce better targeted medicines.

Multidisciplinary Guidelines

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).

WHO (World Health Organization) Guidelines

MHRA (Medicines and Healthcare products Regulatory Agency) Guidelines

Guidance notes for medicines

Other medicines regulatoryguidance

Safety guidance

Safety information

FDA (Food & Drug A ) Guidelines

Guidance,Compliance, & Regulatory Information


Search Drugs and Vaccines, Blood & Biologics Guidances

Regulatory Information


Guidance documents represent FDA's current thinking on a topic.  They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

You also get here:

TGA (Therapeutics Good Agency) Guidelines

Australiancode of good manufacturing practice for medicinal products

TGABasics A-Z guide

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