The European Agency for the Evaluation of Medicinal Products
Evaluation of Medicines for Human Use
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EMEA 2003 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
London, 17 December 2003
EMEA/CPMP/3097/02/Final
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS
(CPMP)
GUIDELINE ON COMPARABILITY OF MEDICINAL PRODUCTS
CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE
SUBSTANCE
NON-CLINICAL AND CLINICAL ISSUES
DISCUSSION IN THE AD HOC GROUP ON COMPARABILITY
January 2001 -
June 2002
TRANSMISSION TO CPMP
July 2002
RELEASE FOR CONSULTATION
July 2002
DEADLINE FOR COMMENTS
January 2003
DISCUSSION IN THE AD HOC GROUP ON COMPARABILITY
April 2003
TRANSMISSION TO ALL THE CPMP WORKING PARTIES
May 2003 –
September 2003
DISCUSSION IN THE AD HOC GROUP ON COMPARABILITY
October 2003
TRANSMISSION TO CPMP
October 2003
FINAL APPROVAL BY THE CPMP
December 2003
DATE FOR COMING INTO OPERATION
June 2004
CPMP/3097/02
2/11
EMEA 2003
TABLE OF CONTENTS
1.
INTRODUCTION................................................................................................................ 3
2. BACKGROUND .................................................................................................................. 3
3. CHANGE IN THE MANUFACTURING PROCESS OF A GIVEN PRODUCT ......... 4
3.1 General considerations ................................................................................................ 4
3.1.1
Non-clinical considerations............................................................................... 4
3.1.2
Immunogenicity ................................................................................................ 5
3.1.3
Clinical considerations ....................................................................