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On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).
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The International Standard ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” outlines what is considered good clinical practice for the design, conduct, recording, and reporting of clinical investigations of medical devices in human participants. As we enter 2025, a Draft International Standard (DIS) of ISO 14155 is in the final stages of the approval process and is expected to be released within the coming months to replace the existing ISO
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In November 2024, the CRC press published the first edition of “Good Clinical Practices in Pharmaceuticals” edited by Graham P. Bunn (President of GB Consulting, LLC) and authored by multiple clinical trial professionals, including Clinical Pathways’ own Jennifer Lawyer and Sandra “Sam” Sather. The book is a compendium of information regarding the Good Clinical Practice (GCP) guidelines including the standards, methodologies, laws, and regulations.
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The guidance breaks down the roles and responsibilities of the investigator, sponsor, and Institutional Review Board (IRB) in regards to monitoring, mitigating, reporting, and evaluating protocol deviations (PDs). The investigator, who is responsible for the conduct of the trial and protection of the rights, safety, and welfare of the participants must report all PDs to the sponsor, highlighting the important PDs.
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On January 6, 2025, the International Council of Harmonisation’s ICH E6(R3) for Good Clinical Practices (GCP) reached step four of the formal ICH procedure. This means that the ICH E6(R3) draft guidelines, since its release in May of 2023, were submitted to and approved by the ICH Regulatory Members of the ICH Assembly for adoption as an ICH Harmonised Guideline replacing E6(R2).
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Now that Brexit has been delayed, there is still no guarantee of a deal. The extension will be until April 12 if the withdrawal agreement is not approved by the UK House of Commons by March 29, and until May 22 if it is. During this time, the UK will continue to be a Member State in the EU. The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are preparing for the possibility of a no deal Brexit.
The United Kingdom (UK) notified the European Union (EU) of its intent to withdraw effective March 30, 2019, a process commonly known as Brexit. At that point, it will become a “third country” and will not follow the EU regulations for pharmaceuticals. Negotiations are underway for a withdrawal agreement. The European Medicines Agency (EMA) and the European Commission have released guidance related to pharmaceutical companies’ distribution of drugs due to the uncertainty of authorization of a withdrawal agreement.
