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USP Publishes Summary of Comments on Chapter <1079.2> Regarding Mean Kinetic Temperature (MKT)

The United States Pharmacopeia (USP) has provided responses to stakeholder feedback on the proposed revisions to General Chapter <1079.2>, Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products.

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EMA: No further Extension of GDP Certificates in 2025

The GMP/GDP Inspectors Working Group decided at the end of 2023 to extend the validity of GDP and GMP certificates that expired at the end of the year until 2024 or until the next on-site inspection, whichever occurs first. It has now been clarified that from 2025, this extension no longer applies.

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Aide-Mémoires and Checklists in GDP Audits - Benefits and Risks

Aide-mémoires and checklists support a structured approach in GDP audits, ensuring that all relevant aspects are considered. In this article, we examine how these tools can be used effectively, the risks they may entail, and what auditors should pay special attention to.

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Illegally imported Medicinal Products into Switzerland in 2024: Fewer Shipments, but increasing Risks

Swissmedic, the Swiss authorisation and supervisory authority for drugs and medical products, has provided information on illegal drug imports into Switzerland. In 2024, 5,668 illegal drug imports were seized, representing a 15% decrease in shipments compared to the previous year. However, the danger remains: Illegal products from dubious online sources often contain incorrectly declared, overdosed, or even no active substances at all, posing significant health risks.

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IPEC: Version 3 of GDP Guide available

In January 2025, version 3 of the IPEC Guide "Good Distribution Practices Guide for Pharmaceutical Excipients" was published on the IPEC website (International Pharmaceutical Excipients Council Europe (IPEC Europe) asbl).

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MHRA updates Guidance on Sourcing Medicines for the UK Market

The UK Medicines & Healthcare products Regulatory Agency (MHRA) has updated its guidance on sourcing medicines for the UK market. The updates are intended to reflect the new UK-wide licensing arrangements for human medicines from 1 January 2025 as part of the Windsor Framework.

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First GDP Non-Compliance Report of 2025: Data Integrity Issues at Hungarian Wholesaler

The competent authority of Hungary has issued a new GDP Non-Compliance Report in the EudraGMDP database. The report mentions two critical observations: data integrity problems and unauthorized personnel performing critical decisions regarding medicinal products.

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2nd Version of the Union list of Critical Medicines published

On 16 December 2024, the European Commission, the HMA  and the EMA, published an updated version of the Union list of critical medicines and the updated version of the corresponding Q&A document.

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Securing Europe's Drug Supply: How EDSForm is Addressing Medicine Shortages

The European Drug Shortages Formulary (EDSForm) project aims to tackle drug shortages across Europe.

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EMA adds Considerations for Wholesale Distributors and Brokers on suspicious Offers

The European Medicines Agency (EMA) has published two new Q&As on its website related to good manufacturing practice and good distribution practice. These are aimed specifically at wholesalers and brokers and provide information on how to recognise suspicious offers and take appropriate action.

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