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On June 3rd, 2026, the International Council of Harmonisation’s final ICH Guideline for Good Clinical Practice (GCP) E6(R3) Annex 2 was adopted in step 4 of the ICH formal procedure. A reminder of ICH’s standardized five-step formal procedure of developing, adopting, and implementing of guidelines can be reviewed.
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On March 9th, 2026, the US Food and Drug Administration (FDA) released a draft guidance “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection”. The guidance is intended to assist drug manufacturers of FDA regulated drugs or combination products who choose to respond to an FDA Form 483 Inspectional Observations (483).
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In March 2026, the International Organization for Standardization (ISO) published the fourth edition of ISO 14155:2026, replacing the previous edition from 2020. This is the medical device global reference for GCP conduct that many regulatory authorities recognize. Clinical Pathways offers an ISO 14155 Comparison Tool to support you to do an impact analysis and plan updates to SOPs, templates and tools for your trials.
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The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) collaborated with the European Medicines Agency (EMA) to develop 10 Guiding Principles of Good AI Practice in Drug Development. They are intended to be a foundational basis for developing good practices with AI, addressing the unique nature of AI, as well as cultivating its future growth.
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In addition to the launch of Elsa, in a press announcement on December 1, 2025, the FDA broadcasted the deployment of Agentic AI capabilities for their employees. Agentic AI is unique from LLM AI due to its capability to plan, reason, and execute multi-step actions in order to achieve a specific goal. This means it can be used to assist with more complex tasks.
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On June 3rd, 2026, the International Council of Harmonisation’s final ICH Guideline for Good Clinical Practice (GCP) E6(R3) Annex 2 was adopted in step 4 of the ICH formal procedure. A reminder of ICH’s standardized five-step formal procedure of developing, adopting, and implementing of guidelines can be reviewed.
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On March 9th, 2026, the US Food and Drug Administration (FDA) released a draft guidance “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection”. The guidance is intended to assist drug manufacturers of FDA regulated drugs or combination products who choose to respond to an FDA Form 483 Inspectional Observations (483).
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On September 8th, 2025, the US Food and Drug Administration (FDA) released their final guidance for industry on the ICH E6(R3) Good Clinical Practice (GCP). ICH E6(R3) Principles and Annex 1 were finalized on January 6th, 2025, officially taking over the preceding 2016 ICH E6(R2). Annex 2 is expected to be finalized in early 2026.
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On January 31st, 2025, the European Medicines Agency (EMA) reached another major milestone for the implementation of the Clinical Trials Regulation (CTR), the European Union’s (EU) current pharmaceutical legislation. The CTR has updated the many of the CTD policies; promoting communication between trials and regulators, increased transparency between trials and the public, and reducing financial and administrative burdens.
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On June 4, 2025 the European Medicines Agency (EMA) posted a guideline titled: ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials. Individuals who are pregnant or breastfeeding make up a significant portion of the world’s population, however, the European Union (EU) reports that less than 0.4% of clinical trials currently submitted to the EU include pregnant people and only 0.1% include lactating individuals. This guideline highlights the importance of including these individuals as well as the steps that should be taken in order to ensure their safety during a trial.
