Guideline on Non-Clinical Local Tolerance Testing of Medicinal Products

On April 30, 2014 the EMA released the Guideline on non-clinical local tolerance testing of medicinal products for comment and is intended to replace theNote for Guidance on non-clinical local tolerance testing of medicinal products’ (CPMP/SWP/2145/00)” which is currently available. Comments on this current guideline are open until July 31, 2014 and can be submitted using the template and address provided on the first page of the attached guideline.

“Local tolerance testing is intended to support human exposure to a medicinal product (both active substance and excipient) at contact sites of the body following clinical use.” This guideline provides guidance on “the non-clinical strategies to be considered when developing a drug product (both active substance and excipients) that will, or potentially could, come into contact with different sites of the body following normal clinical use, as well as after unintentional administration,” and should be “applicable to all types of drug products, including biotechnology-derived pharmaceuticals and herbal products.”

While the “final formulation may not be confirmed until late in clinical development,” this testing should provide support for initial clinical trials and support for the final product. Specifically, “it is recommended that evaluation of local tolerance by the intended clinical route of administration [be] included as part of the general toxicity studies.” Sections 4, 5 and 6 of this guideline cover general considerations and points to consider in the design of local tolerance tests, as well as testing procedures for particular routes of administration.

The complete guideline, including how to submit comments can be accessed here:

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