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Latest report September 2023

Safety Observer 203

The Australian TGA sets new requirements for the reporting of Safety Issues.

Released 07-Sep-2023

Pages 44

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Safety Observer 203 quantity

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Latest report September 2023

Report 203 — Highlights

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.

Past Reports

Safety Observer 202

CIOMS has published the draft report of Working Group XII on Benefit-Risk Assessment..

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Safety Observer 202 quantity

Highlights

Reports July 2023

Report 202 — Highlights

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New FDA Draft Guidance

The FDA has published for comments a new draft guidance entitled “Psychedelic Drugs: Considerations for Clinical Investigations”.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

Safety Observer 201

The ICH E6(R3) draft Guideline on Good Clinical Practice (GCP) has entered the public consultation period..

Number of users

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Safety Observer 201 quantity

Highlights

Reports June 2023

Report 201 — Highlights

ICH E6(R3): GCP

The ICH E6(R3) draft Guideline on Good Clinical Practice (GCP) has entered the public consultation period and various authorities including the FDA, the EMA and the MHRA are inviting stakeholders to submit comments.

CIOMS XIII: RWD & RWE

CIOMS has launched a public consultation on the draft report of Working Group XIII, which covers Real-World Data (RWD) and Real-World Evidence (RWE) in Regulatory Decision Making.

FDA & AI

The FDA is calling for comments on a new discussion paper entitled: “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products”.

FDA: New PMI rule

The FDA has published a Proposed Rule, which would require a new Patient Medication Information (PMI) in replacement of Medication Guides or Patient Package Inserts.

Ethiopia: PV Guideline

The EFDA (Ethiopian Food and Drug Authority) has published the fourth edition of its Pharmacovigilance Guideline, which brings new requirements for MAHs including Local QPPV and PSMF.

Safety Observer 200

The European Commission published proposals for the largest reform of the pharmaceutical legislation in over 20 years..

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Safety Observer 200 quantity

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Reports May 2023

Report 200 — Highlights

EU pharmaceutical reform

The European Commission has published proposals for a new Directive and Regulation to replace the existing pharmaceutical legislation. This is the largest reform in over 20 years but the impact on Pharmacovigilance obligations remains limited.

ICH E6 (R3)

The revision of the ICH E6(R2) guideline on Good Clinical Practice (GCP) aims to address its application to the growing range of clinical trial types and data sources. Both the EMA and the MHRA are setting the scene for the upcoming public consultation.

New FDA Guidance

The FDA has published draft guidance documents for consultation on transdermal and topical delivery systems, one of which covers the assessment of their irritation and sensitization potential.

UK review of isotretinoin

The MHRA has announced the conclusions of their Expert Working Group following the safety review of the acne medicine over the possible persistence of psychiatric and sexual side effects.

AI & PV

A new article explores how Artificial Intelligence (AI) is and may impact Pharmacovigilance in the future.

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Safety Observer 203

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