FDA Guidance on BRA

The FDA has published its final guidance on Benefit-Risk Assessment (BRA), which clarifies how these considerations factor into FDA’s regulatory decisions.

FDA Off-Label Guidance

The FDA has published a revised draft guidance for comments, which covers common questions regarding the communication of scientific information on unapproved use(s) of marketed products.

ePI Pilot in the EU

The EMA has announced that a first set of ePIs (electronic Product Information) has been published as part of the pilot project to test the use of ePI based on the Common Standard adopted in 2022.

New PV Guidelines in Kenya

The Pharmacy and Poisons Board of Kenya has published updates to the guidelines that describe the obligations of Marketing Authorisation Holders in the country.

Partner Audits Toolkit

The Pharmacovigilance Agreements Optimization (PVAO) Initiative of TransCelerate has produced a new toolkit that includes a suite of solutions to help with Marketing Partner Audits.

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New FDA Draft Guidance

The FDA has published a new draft guidance describing how confirmatory evidence may suffice to complement a single clinical investigation to demonstrate effectiveness.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