European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance on 22.Nov.2017. EudraVigilance is the European system for monitoring the safety of medicines. It facilitates electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the...
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...
On 2.May.2017 The National Institues of Health (NIH) and FDA Joint Leadership Council has issued a final version of the protocol template for clinical trial investigators. The NIH-FDA protocol template is primarily intended for clinical investigators who are writing protocols for phase 2 and phase 3 NIH-funded...
It encourages the implementation of more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. The ICH GCP Addendum E6 (R2) from Nov.2016 provides a unified standard for the mutual accptability of...
Serious breaches must be reported to the concerned Member States in Europe within 7 calendar days by the sponsor. Serious breach is a breach that is likely to affect to a significant degree the safety or physical or mental integrity of the participants; or the...
