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In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our Major Changes in GCP from ICH E6(R2) to (R3): Road Map is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.
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In January 2025, the US Food and Drug Administration (FDA) published a draft guidance titled “Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and Biological Products” for trial sponsors and stakeholders intending to use AI to generate data and clinical evidence.
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In March, 2025, the European Medicines Agency (EMA) released a “Reflection paper on use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes” as a guidance for stakeholders on quality planning, conduct and analysis of NISs that intend to use RWD to generate RWE.
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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.
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In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).
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The ICH Q9(R1) international guideline on Quality Risk Management reached step 4 on January 18, 2023. Step 4 is when the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Regulatory Members of the ICH Assembly have adopted the guideline as a harmonized guideline.
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.
