JeanMarc Vidal

1
Scientific and Technical Guidance on Safety and
Quality requirements

• Jean-Marc Vidal
• EMEA
• Safety Efficacy of Medicines
• Pre-Authorisation
• Human Unit

2
Quality requirements for animal testing

• Chemicals quality testing does not normally
  require the use of animals
• Biologicals (biotechnology products, vaccines,
  blood products etc.) animals may used to prove
  the quality (potency, safety testing e.g.
  vaccines)

3
Main areas of non-clinical testing

4
Guidelines containing recommendations for in
vitro approaches (examples) -1

• Concept papers
• CHMP/SWP/151915/04 Concept Paper on the
  development of a CHMP Guideline on the In-Vitro
  investigation of Mitochondrial Toxicity of
  Anti-HIV Medicinal Products
• Guidelines
• CPMP/SWP/728/95  Replacement of Animal Studies
  by In Vitro Models(CPMP adopted February 97)
• CPMP/SWP/398/01  Note for Guidance on
  Photosafety Testing, (CPMP adopted June 2002)
• CPMP/372/01 Final Points to Consider on the
  Non-Clinical Assessment of the Carcinogenic
  Potential of Insulin Analogues (CPMP adopted
  November 2001)

5
Guidelines containing recommendations for in
vitro approaches (examples) 2-

• Guidelines
• CPMP/SWP/2600/01 Final Points to Consider on the
  Need for Assessment of Reproductive Toxicity of
  Human Insulin Analogues (CPMP adopted March 2002)
• EMEA/CHMP/SWP/150115/06 Guideline on Detection
  of Early signals of Drug-Induced Hepatotoxicity
  in Non-clinical Studies (Releaded for
  consultation June 2006)
• CPMP/SWP/2599/02 rev 1  Position Paper on the
  Non-Clinical Safety Studies to support Clinical
  Trials, with a single low dose of a compound
  (CPMP adopted June 2004)
• CHMP/SWP/169215/05 Guideline on the need for
  Non-Clinical Testing in Juvenile Animals on Human
  Pharmaceuticals for Paediatric Indications
  (Released for consultation 11 October 2005)

6
3Rs rule

• Is the 3Rs rule applied in regulatory testing ?
• Reduction yes (harmonisation, more scientific
  investigations)
• Refinement yes (GLP, ethical committees)
• Replacement No, only partially for specific
  endpoints

7
Conclusion

• Legislation requires areas of testing (not
  testing itself)
• Guidelines recommend testing in various degrees
  of detail
• In vitro approaches are widely recommended in
  current safety guidelines
• However, in vivo testing is still need for the
  overall safety evaluation