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...
EMA recently published 2016 annual inspection report, which describes its inspection activities in 2016. The EMA GCP inspectors working group (IWG) focuses on the harmonisation and coordination of GCP-related activities at EU level. Most inspections were carried out in the EU/EEA/EFTA (42%) followed by inspections in...
Guideline outlines strategies to identify and mitigate risks for trial subjects The finalised guideline – issued on 20 July 2017 – will take effect on 1 February 2018. The European Medicines Agency (EMA) has revised its guideline on first-in-human clinical trials to further help stakeholders identify and...
FDA and Office for Human Research Protections (OHRP) have relapsed final guidance that answers commonly asked questions on using electronic systems and processes to obtain informed consent. The guidance provides recommendations on the use of electronic system and processes to obtain informed consents such as graphics,...
The EU Clinical Trial Regulation will now come into application in 2019 instead of October 2018, as previously scheduled. EMA’s priority is to ensure that a high quality and functional system is delivered to the EU regulatory network and its stakeholders. Due to technical difficulties with the...
