FDA has updated its technical specifications guidance on submitting next-generation sequencing protocols, data and analyses to the Division of Antivirals.

Health Canada published feedback from its public consultation on Decentralized Clinical Trials, including topics related to digital technologies and data management.

ICH has adopted E6(R3) Annex 2, introducing new Good Clinical Practice guidance for decentralised clinical trials, digital health technologies and real-world data. Learn what it means for medical device manufacturers.

The FDA has adopted ICH M11 CeSHarP, introducing a harmonized framework for clinical trial protocols. Discover the impact on sponsors and global studies.

ANVISA’s new 2024–2025 GCP inspection report highlights critical findings in clinical trials, data integrity, electronic systems, SOPs, and investigational product management. Learn what manufacturers and sponsors should review.

FDA opens consultation on a pilot program to assess artificial intelligence in early-phase clinical trials, focusing on efficiency, safety, and decision-making.

MHRA clarifies alignment between the Declaration of Helsinki and amended UK Clinical Trial Regulations effective April 2026. Key impacts for sponsors and manufacturers.

MHRA updates clinical trial record retention rules to 25 years. Key implications for manufacturers, TMF management, and UK regulatory compliance.

FDA releases draft guidance on Bayesian methods in clinical trials. Learn how device manufacturers can benefit from this innovative approach.

The FDA's new M11 technical specification, developed within the framework of ICH, defines a structured and harmonized electronic template for clinical protocols - CeSHarP. This document promotes the international standardization of clinical trial documentation, facilitating electronic submission and regulatory interoperability between agencies such as the FDA, EMA and PMDA.