INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE V IRAL S AFETY E VALUATION OF B IOTECHNOLOGY P RODUCTS D ERIVED FROM C ELL L INES OF H UMAN OR A NIMAL O RIGIN Q5A(R2) Final version Adopted on 1 November 2023 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 ICH regions.