DIRECTIVES AND GUIDELINES --------------------------------------------------------------------------------------------------------------------------------------------------------------------- Commission Directive 1999/11/EC Good Laboratory Practice Good laboratory practice: Inspection and Verification Council Directive 88/320/EEC Inspection and verification of good laboratory practice (09JUN88) Commission Directive 90/18/EEC Good laboratory practice: inspection and verification (18DEC89) Mutual recognition of OECD GLP - European Community & Israel Commission Directive 1999/12/EC Annex to Council Directive 88/320/EEC GLP (08MAR99)

SAFETY WORKING PARTY (SWP) --------------------------------------------------------------------------------------------------------------------------------------------------------------------- Repeated Dose Toxicity Safety Studies for Gene Therapy Products Assessment of the Potential for QT Interval Prolongation by Non-cardio Products DRAFT Pre-Clinical Evaluation of Anticancer Medicinal Products Preclinical Pharmacological and Toxicological Testing of Vaccines Replacement of Animal Studies by In Vitro Models Revision of CPMP Note for Guidance on Carcinogenic Potential Immunotoxicity: Revision of CPMP Guidance on Repeated Dose Toxicity

INTERNATIONAL CONFERENCE ON HARMONIZATION --------------------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Site ICH Safety Topics

CPMP PUBLICATIONS OF ICH SAFETY TOPICS --------------------------------------------------------------------------------------------------------------------------------------------------------------------- Topic S1A Need for Carcinogenicity Studies of Pharmaceuticals Topic S1B Carcinogenicity: Testing for Carcinogenicity of Pharmaceuticals Topic S1CR Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addition of a Limited Dose Topic S2A Genotoxicity: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals Topic S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals Topic S3A Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies Topic S3B PharmacoKinetics: Guidance for Repeated Dose Tissue Distribution Studies Topic S4A Duration of Chronic Toxicity Testing in Animals (Rodent and non Rodent Toxicity Testing Topic S5A Reproductive Toxicology: Detection of Toxicity to Reproduction for Medicinal Products Topic S5B Reproductive Toxicology: Toxicity on Male Fertility Topic S6 Preclinical Safety Evaluation of Biotechnology-Derived Products Topic M2 Recommendations on Electronic Transmission of Individual Case Safety Reports Message Specs Topic M3 Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals Topic M4 Common Technical Document for Registration of Pharmaceuticals