Industry Updates

Regulatory Corner

To learn more about how each Regulatory Agency defines the TMF/Essential Documents, please use this page to discover more information and visit the respective link's accompanying each agency.


About MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA defines the trial master file (TMF) as the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed.


About 21 CFR Part 11

Title 21 is the portion of the Code of Federal Regulations (CFR) that governs food and drugs within the United States for the Food and Drug Administration (FDA) and other government organizations. Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries. It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain.


About TMF Reference Model Version 3

The TMF Reference Model is managed by the Drug Information Association (DIA) Document and Records Management Community. The TMF Reference Model provides standardized taxonomy (scheme of classification) and metadata and outlines a reference definition of TMF content using standard nomenclature. This is useful to the following: Contract Research Organizations and vendors servicing TMFs, including technology providers; TMF consultants; and regulators who wish to overcome the challenges of different TMF terminology and file structures that create inefficiency and a higher degree of variability during sponsor audits.


About ICH E6

The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. The revision to the ICH Guideline for Good Clinical Practice (E6 R2 Addendum) primarily addresses quality management with a focus on risk identification, evaluation, control, review and reporting. This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities, to satisfy the FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) evidence requirement.