Posted 17 May 2012
By Alexander Gaffney
The US Food and Drug Administration (FDA) released a new addendum to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use's (ICH) guidance on preclinical safety evaluation of biopharmaceuticals, advancing the harmonized regulatory procedure for eventual adoption by the agency.
The guidance, "S6 Addendum to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (S6 Addendum)" updates the original S6 guidance to include new information and provide clarification on the best methods to ensure preclinical safety of new biopharmaceutical products.
These biopharmaceutical products include protein therapeutics, diagnostics, and prophylactic products derived from cell-culture systems.
ICH explains in the concept paper for S6 that it sought to amend the existing guidance as a result of growing "disharmony across regulatory regions" as the result of varying implementation and issuance of Points to Consider documents.
The addendum clarifies a number of sticking points, including the selection of biological species as the base of a biopharmaceutical product, how studies are to be conducted, conducting reproductive and developmental toxicity studies, and testing for carcinogenicity and immunogenicity issues.
"In addition, the S6 addendum harmonizes approaches given in both ICH S6 and the ICH guidance "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals," writes FDA.
Comments on the guidance are due at any time.
FDA - International Conference on Harmonisation Guidance; Availability: S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; Addendum
ICH - Final Concept Paper - S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
ICH - Safety Guidelines