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International council for harmonisation of technical requirements for pharmaceuticals for human use ( ich) ich harmonised guideline integrated addendum to ich e6( r1) : guideline for good clinical practice e6( r2) current step ich guidelines pdf 4 version dated 9 november e6( r1) document history first codification history ich guidelines pdf date new codification november. ich guidelines are comprehensive sets of recommendations for the development of medicines and the protection of public health. ich harmonised guideline quality risk management q9( r1) draft version endorsed on 18 november currently under public consultation. a list of ich guidance documents in pdf format, covering topics such as clinical study reports, ethnic factors, quality risk management, and special populations. at step 2 of the ich process, a consensus draft text or guideline, agreed by the appropriate guidelines ich expert working group, is transmitted by the ich assembly to the regulatory authorities of the ich regions for internal and external consultation, according to national or regional procedures. the documents are recommendations from the international conference on harmonization ( ich) on how to conduct clinical trials in human and veterinary subjects. this guideline addresses the diagnosis, treatment, and prevention of ich in adults and is intended to update and replace the aha/ asa ich guideline. q2( r2) document history.
they cover topics such as quality, safety, efficacy and multidisciplinary issues, and are available in pdf format. 12 this guideline is limited explicitly to spontaneous ichs that are not caused by head trauma and do not have a visualized structural cause such as vascular malformation, saccular.
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