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FDA: PMRs and PMCs

The FDA has published the final guidance to explain how to submit information on postmarketing requirements (PMRs) and postmarketing commitments (PMCs).

FDA & Clinical Trial Disruptions

The FDA has published a new final guidance describing approaches that can be considered when there is a major disruption to clinical trial conduct due to public health emergencies or disasters.

New FDA Draft Guidance

The FDA has published a new draft guidance describing how confirmatory evidence may suffice to complement a single clinical investigation to demonstrate effectiveness.

Switzerland ADR Reporting

The Swiss Agency has updated its Pharmacovigilance guidance, which bring new requirements for the Medical Assessment of cases reported to Swissmedic from 01-Jan-2024.

FDA: RWD and RWE Studies

The FDA has now published the final guidance on Considerations for the use of Real-World Data (RWD) and Real-World Evidence (RWE) in regulatory decision making.

EMA & AI

The EMA has published a new draft reflection paper for public consultation on the use of Artificial Intelligence (AI) in the medicinal product lifecycle.

Australia: Updated PV Guidance

The Australian TGA has issued an updated version of its Pharmacovigilance Guidance document, which brings new requirements for the reporting of Safety Issues.

MHRA GPvP Inspection Metrics

The MHRA has published a new Pharmacovigilance inspection metrics report, which covers inspections conducted from April 2021 to March 2022.

Pakistan: QPPV/LSO notification

The Drug Regulatory Authority of Pakistan has set a new deadline for companies to comply with the obligation to nominate a Qualified Person for Pharmacovigilance or Local Safety Officer.

CIOMS XII: BRA

CIOMS has launched a public consultation on the draft report of Working Group XII, which provides an overview of Benefit-Risk Assessment (BRA) methods.

ICH consults on RWE

ICH is calling for comments on a Reflection Paper for the International Harmonisation of Real-World Evidence (RWE) Terminology.

FDA Guidance for DTC ads

The FDA has published the final guidance entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements”.

New FDA Draft Guidance

The FDA has published for comments a new draft guidance entitled “Psychedelic Drugs: Considerations for Clinical Investigations”.

Egypt GVP Guideline

The EDA (Egyptian Drug Authority) has published a new version of the Guideline on Good Pharmacovigilance Practice (GVP) in Egypt.