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Safety Observer 216

The FDA has published the final guidance on Neurodevelopmental Safety Studies in Neonates.

Released 06-Nov-2024

Pages 39

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Latest report November 2024

Report 216 — Highlights

FDA & Neonatal Safety

The FDA has published the final guidance entitled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development”.

EU Variation Regulation

Further to the publication of amendments to the Variation Regulation in June 2024, the CMDh and the EMA have published guidance to support variation applications implemented and submitted from 01-Jan-2025.

EMA: PhV Inspectors Report

The EMA has published the Annual Report of the Pharmacovigilance Inspectors Working Group for 2023, which provides an overview of inspections and findings in the period.

Ethiopia: New PV Guideline

The Ethiopian FDA has published a new version of its National Pharmacovigilance Guideline, which describes the obligations of MAHs.

Pakistan: e-submission of ICSRs

The Drug Regulatory Authority of Pakistan (DRAP) has announced the launch of an e-reporting System for ICSRs, which registration holders are required to use from 08-Nov-2024.

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Safety Observer 215

India issues revised Pharmacovigilance Guidance for MAHs..

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Reports October 2024

Report 215 — Highlights

MedDRA PtC Companion Document

The MSSO (Maintenance and Support Services Organization) has published Version 3.0 of the MedDRA Points to Consider (PtC) Companion Document, with a new section on coding product manufacturing deviations and non-conformances.

FDA & Electronic Systems

The FDA has published the final guidance entitled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”.

EMA Reflection Paper on AI

The EMA has published the final version of the reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle.

Switzerland & Clinical Trials

Swissmedic has published a revised version of its Information Sheet on Safety Reporting in clinical trials, which will apply from 01-Nov-2024.

India: New PV Guideline for MAHs

The Ministry of Health of India has published the final revision of its “Pharmacovigilance Guidance Document for the Marketing Authorization Holders of Pharmaceutical Products”.

Safety Observer 214

EMA issues revised version of GVP Module XVI on Risk Minimisation Measures..

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Reports September 2024

Report 214 — Highlights

GVP Module XVI on RMMs

The EMA has published Revision 3 of Module XVI on Risk Minimisation Measures (RMMs) and its Addendum on the methods for evaluating the effectiveness of RMMs.

New FDA Draft Guidance

The FDA has announced the availability of a new draft guidance to help assess and mitigate risks related to the user interface of combination products.

MHRA: New PV guidance

The MHRA has announced changes to Pharmacovigilance requirements in the UK following the agreement of the Windsor Framework, which will come into force on 01-Jan-2025.

Medsafe & Clinical Trial Safety

Medsafe launched a consultation on revised guidelines for the conduct of clinical trials in New Zealand. The proposal includes a new document on “Clinical Trial Safety Monitoring and Reporting”.

Safe Use & Pregnancy

A consultation has been launched in France on proposed changes to the pregnancy pictogram, which is presented on the packaging of medicines to warn about their teratogenic or foetotoxic risks.

Safety Observer 213

ICH issued a revised Reflection Paper on RWD and RWE harmonisation..

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Reports July 2024

Report 213 — Highlights

ICH: RWD/RWE Harmonisation

The ICH Assembly endorsed a revised Reflection Paper on RWD and RWE harmonisation, which follows the public consultation held from June to September 2023.

FDA: New AI Program

The FDA has announced the launch of the new Emerging Drug Safety Technology Program (EDSTP) to promote the use of AI and other emerging technologies in Pharmacovigilance.

FDA Inspections

The FDA has published the final guidance entitled “Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection”.

EU Variation Regulation

Amendments to the EU Variation Regulation have been published and will apply from 01-Jan-2025. Interested parties are invited to comment on proposed amendments to the associated guidelines.

Botswana PV guidance

The Botswana Medicines Regulatory Authority (BoMRA) has published a revised version of the document entitled “Pharmacovigilance Guidance for Market Authorization Holders”.

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Safety Observer 216

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