Transcription of ICH HARMONISED TRIPARTITE UIDELINE
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ICH HARMONISED TRIPARTITE UIDELINE
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL. REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN. USE. ICH HARMONISED TRIPARTITE GUIDELINE. VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY. PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR. ANIMAL ORIGIN. Q5A(R1). Current Step 4 version dated 23 September 1999. This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH. Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. Q5A(R1). Document History First History Date New Codification Codification November 2005. Q5A Approval by the Steering Committee under Step 2 1 December Q5A. and release for public consultation. 1995. Q5A Approval by the Steering Committee under Step 4 5 Q5A. and recommendation for adoption to the three March 1997. ICH regulatory bodies. Current Step 4 version Q5A Approval by the Steering Committee of the post 23 Q5A(R1).
VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN I. INTRODUCTION This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal
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