Blog
ICH E6(R3)
04/10/2023
The ICH E6 Good Clinical Practice Guideline was first finalised in 1996 to harmonise working practicesbetween the key clinical research regions of Europe, the USA and Japan. The guideline has really stood thetest of time, which is a testament to the fine work undertaken by the ICH Expert Working Group (EWG)and of course their foresight. Many regions and countries are now part of the ICH family and the E6Guideline has become a global standard.
New international recognition route for authorising medicines in the UK
04/10/2023
The Medicines and Healthcare products Regulatory Agency(MHRA) has created a new international recognition route for medicines, utilising pre-existing approvals from Australia, Canada, the EU, Japan, Switzerland, Singapore and the USA.
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