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Q&A Version 22 on Safety Features for Medicinal Products

Version 22 of the Q&A on Safety features contains important clarifications regarding regulatory authorities’ access to Audit Trail data.

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GDP for APIs: APIC Publishes Updated "How to Do" Document

An updated version of the document “GDP for APIs: How to do” has been published on the APIC website. In addition to other revisions, the guide now also includes practical guidance on the good distribution practice of active substances used as starting materials in veterinary medicinal products.

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Where to Find Information on UK Wholesale Authorisations

During several GDP events in the first half of 2026, participants asked where to find information on currently valid and no longer valid wholesale distribution authorisations in the United Kingdom. The UK Medicines and Healthcare products Regulatory Agency (MHRA) provides this information and last updated its register of licensed wholesale distribution sites in July 2026.

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Call for Presentations: GDP Forum 2027 in Berlin

Since 2021, the GMP & GDP Forum has taken place every two years, bringing together the European GMP Conference and the European GDP Forum. The next event will take place from 22 to 24 June 2027 in Berlin, Germany. We are inviting interested experts to submit proposals for presentations as part of the GDP programme.

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Questions and Answers from the ECA Webinar "GDP Update 2026" - Part 5

Around 120 participants attended the ECA Webinar “GDP Update 2026” in March. Many interesting aspects were discussed during the Q&A session. After the event, the speaker, Dr Christian Grote-Westrick, provided written responses to the submitted questions. We have compiled a selection of these questions and answers for you – read Part 5 (final part) here, covering the topics of MKT, EMA, and miscellaneous topics.

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GDP in Hong Kong: Authority Provides Additional Information

As previously reported, the competent authority in Hong Kong, the Pharmacy and Poisons Board, launched a public consultation on the introduction of Good Distribution Practice (GDP). The consultation has now been completed. The authority has now published additional information in a presentation, which is available for download as a PDF file.

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GDP Non-Compliance Report: Spanish Authority Found 29 Deficiencies During an Inspection of a Wholesale Distributor

The Spanish competent authority has published a new GDP Statement of Non-Compliance on EudraGMDP. An inspection identified 29 deficiencies across the company’s GDP system, including 8 critical and 10 major findings.

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GDP Inspection Responses: MHRA’s Expectations for AI Use in GxP Replies

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a new post entitled “Use of AI for GXP inspection responses: setting standards without stifling innovation” on the Inspectorate blog. The article focuses on submissions to the MHRA Compliance Teams following GxP inspections and is therefore also relevant for GDP-regulated activities.

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FDA Warning Letter to Amazon: Unapproved New Drugs Sold via Online Marketplace

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Amazon.com, Inc. following an FDA review of labeling and marketing claims for drug products purchased via the website and distributed to U.S. consumers through the “Fulfillment by Amazon” service.

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USP Proposes to Revise the Definition of Controlled Room Temperature in Chapter <659>

The United States Pharmacopeia (USP) has published a proposal to revise General Chapter <659> Packaging and Storage Requirements, focusing on the compendial definition of Controlled Room Temperature (CRT). The aim is to better align USP terminology with the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and WHO usage, where “room temperature” is defined as 15–25 °C.

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