Europe – EU official says ICH Q6B is outdated and needs revision

The International Council for Harmonization’s (ICH) Q6B guideline setting acceptance criteria for new biological products needs to be revised to incorporate a more patient-centric approach and to include the science and risk-based concepts embodied in other ICH guidelines, according to a regulator from the EU.

Mats Welin, a senior expert for vaccines and monoclonal antibodies (MAbs) for the Swedish Medical Products Agency, made this assertion at the 30 November webinar sponsored by the International Society for Pharmaceutical Engineering (ISPE) on patient-centric specifications. He said that the current practice of setting specifications based on a limited number of batches is contrary to the concept of setting specifications tailored to patients.

He added that “industry needs to better address why their proposed limits can be considered clinically justified.”…