GCP inspection findings/observations in clinical trials forming the basis for an application for marketing authorizations for new medicinal products or for extending indications to already authorized products have two main implications: Some findings point to GCP non-compliance issues affecting the safety, well-being and the rights...

The MHRA (Medicines and Healthcare Products Regulatory Agency) UK has recently released the annual report of GCP inspection findings from 2016. A total of 10 commercial sponsors were inspected and there were 3 critical findings from 3 organisations. Critical finding 1: At the previous GCP inspection in 2013...

The FDA has maintained confidentiality agreements with European regulators (European Medicines Agency EMA) since 2003, which have allowed for the exchange of information as part of the respective regulatory and scientific process. However, the FDA and EMA could not, under these arrangements, share full inspection...

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