[F1 ANNEX I U.K. ANALYTICAL, PHARMACOTOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTS

Textual Amendments

F1 Substituted by Commission directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance).

PART I U.K. STANDARDISED MARKETING AUTHORISATION DOSSIER REQUIREMENTS

5. MODULE 5: CLINICAL STUDY REPORTS U.K.

5.1. Format and Presentation U.K.

The general outline of Module 5 is as follows:

• Table of contents for clinical study reports

• Tabular listing of all clinical studies

• Clinical study reports

  • Reports of Bio-pharmaceutical Studies

    • Bio-availability Study Reports

    • Comparative Bio-availability and Bio-equivalence Study Reports

    • In vitro — In vivo Correlation Study Report

    • Reports of Bio-analytical and Analytical Methods

  • Reports of Studies Pertinent to Pharmaco-kinetics Using Human Bio-materials

    • Plasma Protein Binding Study Reports

    • Reports of Hepatic Metabolism and Interaction Studies

    • Reports of Studies Using Other Human Bio-materials

  • Reports of Human Pharmaco-kinetic Studies

    • Healthy subjects Pharmaco-kinetics and Initial Tolerability Study Reports

    • Patient Pharmaco-kinetics and Initial Tolerability Study Reports

    • Intrinsic Factor Pharmaco-kinetics Study Reports

    • Extrinsic Factor Pharmaco-kinetics Study Reports

    • Population Pharmaco-kinetics Study Reports

  • Reports of Human Pharmaco-dynamic Studies

    • Healthy Subject Pharmaco-dynamic and Pharmaco-kinetics/Pharmaco-dynamic Study Reports

    • Patient Pharmaco-dynamic and Pharmaco-kinetics/Pharmaco-dynamic Studies Study Reports

  • Reports of Efficacy and Safety Studies

    • Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication

    • Study Reports of Uncontrolled Clinical Studies

    • Reports of Analyses of Data from More than One Study including any formal integrated analyses, meta-analyses and bridging analyses

    • Other Study Reports

  • Reports of Post-marketing Experience

• Literature references]