News Archive

MHRA - GPvP Inspection Metrics report for April 2020 to March 2021

21st December 2021

MHRA adds GPvP Inspection Metrics report for April 2020 to March 2021

MHRA - MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions

21st December 2021

In October 2020, the MHRA launched a 6-week consultation with stakeholders on the MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions. Following the consultation and an analysis of the responses received, the MHRA has published two guidance documents.

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MHRA - RWD Guidance

21st December 2021

MHRA's new guidance on using real-world data to support clinical trials could get medicines to patients sooner

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EMA - CTIS Highlights Issue 6

16th December 2021

EMA have just released their CTIS Highlights newsletter

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MHRA Blog - Global reflections on international inspection transformation: ICMRA remote inspections

16th December 2021

Global reflections on international inspection transformation: ICMRA remote inspections

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EC - Good Lay Summary Practice

7th December 2021

The European Commission (EC) has published a guideline on Good Lay Summary Practice"(GLSP). The guideline was adopted by the Clinical Trials Expert Group (CTEG) of the EU Commission, which is composed of representatives of ethics committees and national competent authorities.

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