Transcription of Q 3 B (R2) Impurities in New Drug Products
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Q 3 B (R2) Impurities in New Drug Products
European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged June 2006 CPMP/ICH/2738/99 ICH Topic Q 3 B (R2) Impurities in New drug Products Step 5 NOTE FOR GUIDANCE ON Impurities IN NEW drug Products (CPMP/ICH/2738/99) TRANSMISSION TO CHMP November 1999 TRANSMISSION TO INTERESTED PARTIES November 1999 RELEASE FOR CONSULTATION November 1999 DEADLINE FOR COMMENTS May 2000 APPROVAL BY CPMP February 2003 DATE FOR COMING INTO OPERATION August 2003 REVISED ATTACHMENT 2 June 2006 EMEA 2006 2 TABLE OF CONTENTS I. INTRODUCTION 3 OBJECTIVE OF THE GUIDELINE 3 BACKGROUND 3 SCOPE OF THE GUIDELINE 3 II.
of impurities in new drug products produced from chemically synthesised new drug substances not previously registered in a region or member state. 1.2 Background This guideline is complementary to the ICH Q3A(R) guideline “Impurities in New Drug Substances”, which should be consulted for basic principles.
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