The Investigations Operations Manual (IOM) is the primary operational reference for FDA investigators. Although primarily used internally by FDA staff, it is available publicly. The Manual has now been revised.
The U.S. Food and Drug Administration (FDA) is providing summary data from mandatory registration of cosmetic product facilities and listing of cosmetic products.
The USP republished the proposed new USP chapter <1568> Cannabis Inflorescence Quality Attributes for Clinical Investigations. The revised draft is open for comment until 31 July 2025.
The European GDP Association (GDPA) is conducting a survey to gather insights into the implementation of GDP requirements across different regions. We invite all stakeholders involved in GDP to take part in this initiative. Participation will take only about 10 to 15 minutes.
The Competent Authority of Germany (Landesamt Fuer Gesundheit Und Soziales Mecklenburg Vorpommern) has entered a new GDP Non-Compliance Report into the EudraGMDP database.
The European Medicines Agency (EMA) has published the "ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths biowaiver - Step 2b". Comments on the draft can be submitted until 9 July 2025.
In April 2025, the Health Products Regulatory Authority (HPRA) released Version 8 of its Guide to Good Distribution Practice of Medicinal Products for Human Use. While primarily aimed at wholesalers and brokers based in Ireland, the updated guide provides insights into regulatory expectations that are relevant for all stakeholders involved in the distribution of medicines across the EU.
On 26 March 2025, the FDA and the Partnership for DSCSA Governance (PDG) held a virtual town hall focusing on the upcoming end of the manufacturer exemption under the Drug Supply Chain Security Act (DSCSA). Two further sessions are planned for wolesale distributors and dspensers.
Around 60 participants attended the ECA Webinar "GDP Update 2025" in March. Many interesting aspects were discussed in the Q&A session. After the event, the speaker, Dr. Christian Grote-Westrick, answered the submitted questions in writing. We have compiled a selection of these questions and answers for you read Part 2 here.
Good Distribution Practice (GDP) places high demands on the Responsible Person. This role is crucial for complying with legal and regulatory requirements and for ensuring the quality and integrity of medicinal products throughout the distribution process. But what specific tasks and responsibilities does this position involve?