EMA: Concept paper on the need for revision of the Guideline on non-clinical local tolerance testing of medicinal products (CPMP/SWP/2145/00).

The existing guideline on local tolerance is dated 1 March 2001 (1). Over the past years, newer routes of administration, e.g. transdermal systems, are being used more frequently and a shift has been observed towards the regulatory acceptance of scientifically valid in vitro methods as well as formally validated in vitro methods as part of an integrated testing strategy. In addition, recently the ICH Guideline M3(R2) - Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals (2) – came into force and included a section on local tolerance.