REGULATORY PUBLIC DISCLOSURE (RPD) - April

Health Canada's Final Guidance on "Public release of clinical information" 12 March 2019

Health Canada have concluded their "Public Release of Clinical Information" consultation.

The overview and table of contents for the final HC guidance document are helpful for navigation purposes.

Read the full final HC guidance document.

No-deal Brexit Scenario: Guidance on UK public registry postings for clinical trials

On 20 March 2019, the UK Government released guidance on the registration of clinical trials for investigational medicinal products and publication of summary results.

This guidance contains information about registration of clinical trials, publishing trial results and future requirements if the UK leaves the EU without a deal.

Remember that until the UK’s exit from the EU is clearer (date and manner of exit), this guidance represents the UK’s preparedness position in the event of a ‘no deal’ only.

PhUSE White Paper

Read the ‘Retrospective versus proactive anonymization of narratives’ White Paper dated 14 March 2019 from PhUSE.

Regularly review the PhUSE White Paper archive for new and updated material. 

Resources

• UK Health Authority MHRA published guidance on “UK QPPV” and “UK PSMF” for no deal Brexit scenario
• New safety features for medicines sold in the EU against falsified medicines
• EMA updated Q&A on article 31 pharmacovigilance referrals
• EMA updated Q&A on article 20 non-pharmacovigilance procedures