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New FDA Draft Guidance

The FDA has produced a new draft guidance to help Investigators comply with the safety reporting requirements in Clinical Trials. The FDA has also published two additional draft documents on the use of RWE in regulatory decision making, and on the considerations that factor into FDA’s benefit-risk assessments.

New Malaysia GVP Guideline

The NPRA Malaysia has published the first edition of the Malaysian Guidelines on Good Pharmacovigilance Practices, which brings new PSMF requirements for Registration Holders.

EU Guidance on “Lay Summary”

The European Commission has published a new “Good Lay Summary Practice” Handbook to help produce summaries of clinical trial results in lay language, as required in the new EU Clinical Trial Regulation that will enter into force on 31-Jan-2022.

MHRA guidance on access to EHRs

The MHRA has published new guidance that describes the expectations regarding remote access to Electronic Health Records (EHRs) for Monitors and Auditors.

EU Clinical Trial Regulation

The notice has now been published in the Official Journal of the EU. As a result, the countdown has started for the entry into application of the Clinical Trials Regulation on 31-Jan-2022.

EU consults on Pharmacovigilance

The European Commission has started a new consultation on proposed changes to the Implementing Regulation (IR) on the performance of pharmacovigilance activities, which was adopted in 2012.

EMA Signal Detection Pilot

The EMA has updated the information on the Signal Detection Pilot, which requires participating MAHs to monitor EudraVigilance data. Further to a prior extension, the Pilot will now run until the end of 2022.

Hong Kong updates PV Guidance

The Drug Office of Hong Kong has published revisions to the existing guidance on Adverse Drug Reaction Reporting Requirements, which now includes details regarding Advanced Therapy Products.

PSURs for COVID-19 Vaccines

The EMA has published new guidance to address specific considerations for PSURs, which specifies additional requirements for COVID-19 Vaccines.

MHRA, Health Canada and DSURs

The MHRA and Health Canada have jointly published a new guidance document that requires DSURs to describe how each signal was evaluated in the region-specific information section of the DSUR.

FDA Trial Safety Reporting

The FDA has published a new Draft Guidance on Safety Reporting Requirements for Clinical Trials, which incorporates the December 2015 Draft Guidance on Safety Assessment for IND Safety Reporting after consideration of the feedback received during earlier consultations.

EMA consults on ePI

The EMA has launched a new public consultation on the proposed Common EU Standard for electronic Product Information (ePI), which is intended to be used for medicines across the EU.

ANSM and PV in Compassionate Use

The schemes for Compassionate Use have been revised in France and the French Agency has published a series of Q&As to clarify Pharmacovigilance requirements associated to these programmes.