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Comparator products in bioequivalence/therapeutic equivalence studies

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Document information
ByMedicines and Healthcare products Regulatory Agencyjade_kite_f61ab8

Information on comparator products used in studies supporting abridged marketing authorisation application.

Adapted edition

Medical device safety
Document type
Reference Guide
Format
DOCX
Pages
6
Language
English
Version
1.0
Updated
2026-09-17
Category
Safety & operations
Licence
Open Government Licence v3.0
Description

Information on comparator products used in studies supporting abridged marketing authorisation application. Consult the original guidance for current legal and operational details.

Contents
  • 1. Overview
  • Until and including 31 December 2024
  • From 1 January 2025
  • 1.1 Reference medicinal products
  • 1.2 Comparator products used in bioequivalence and therapeutic equivalence studies
  • 2. Scope
  • 3. General principles
  • 3.1 Responsibility
  • 3.2 Source country of non-UK CP
  • 3.3 Identicality vs. representativeness
  • 3.4 Demonstration of identicality of the non-UK CP to the UK RMP
  • 3.5 Demonstration of representativeness of the non-UK CP to the UK RMP
  • 3.6 Number of batches to be tested
  • 3.7 Analytical methods
  • 3.8 Acceptability of approach
  • 4. Contact
Source and licence
Comparator products in bioequivalence/therapeutic equivalence studies

Medicines and Healthcare products Regulatory Agency

Original source OGL-UK-3.0

AttributionMedicines and Healthcare products Regulatory Agency, ‘Comparator products in bioequivalence/therapeutic equivalence studies’ (updated 20 December 2024), reused under the Open Government Licence v3.0.

ChangesNeutral text-only adaptation from the official GOV.UK Content API body: headings, paragraphs, ordered and unordered list items and clickable source-link destinations in an appendix preserved. Images, logos, page design, accessible-format request widgets and linked attachments excluded; normalised whitespace, invisible format marks and typography.

Version history
  • v1.017/09/2026
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