The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.
To get other ICH guidelines (e.g. Safety, Efficacy, Multidisciplinary), as well as current status of new ICH Guidelines: Click Here (Free From Internet).
Newly Added Guidance Documents: Click Here Sortable list of the most recent Guidance Documents will be retained in the above link of the page for a period of three months. The most recently added appears first and they are in the order of the date they were issued.
All PIC/S GMP documents are available from internet without any charge, Click Here. Protected documents are for PIC/S Members-only and require a login pass.
European Commission GMP Guidelines
Here you can download almost all EC EudraLex - Volume 4 GMP guidance directly from internet without any charge, Click Here.
WHO medicines quality assurance guidelines
This below web page links to all current WHO medicines quality assurance guidelines which are grouped in development, production, distribution, inspection, quality control and other regulatory guidelines. The guidelines under development /for comment are under current projects, Click Here.
The European Medicines Agency’s scientific guidelines
The Agency strongly encourages applicants and marketing authorisation holders to follow these Quality Guidelines. Here you can download almost all EMA guidances directly from internet without any charge,Click Here.
Medicines and Healthcare products Regulatory Agency (MHRA) guidance documents
Access MHRA guidance on good practice (Click Here) for information on the inspection process and staying compliant.
Japanese GMP Guidelines
To access Pmda ( Pharmaceuticals and Medical Devices Safety) documents and news information please Click Here.
Canadian GMP Guidelines
Click Here to download Health Canada's guidance documents.