Broad-Based ICH Q12 Expert Working Group Supporting Initiative’s Urgency and Viability, EWG Members Affirm at GPhA Conference

The broadening of the ICH Q12 Expert Working Group (EWG) to include parties not traditionally associated with the ICH process may be facilitating, rather than hindering, the effort to meet the tight timelines set up for the guideline’s completion as well as enhancing its global relevance, EWG members are affirming.

The recognition across the different industry sectors and agencies involved in the EWG of the stakes in finding a more viable and harmonized approach to post-approval change regulation is heightening the sense of urgency around completing the ICH Q12 project.

The Q12 EWG is the largest in ICH history, currently including 34 individuals representing 15 different organizations.

Along with the six traditional parties from the US, Europe, and Japan, the EWG includes representatives from new ICH members Health Canada and Swiss Medic and official observers from the regulatory agencies of Taiwan and Singapore and from the World Health Organization (WHO). Both the assessment and inspection components of the various agencies involved are participating.

Also representing a broad swathe of industry as observers are: ● the International Generics and Biosimilars Association (IGBA) ● the Biotechnology Industry Organization (BIO) ● the Active Pharmaceutical Ingredients Committee (APIC), and ● the World Self-Medication Industry (WSMI).

At a session on ICH Q12 at the Generic Pharmaceutical Association (GPhA) Fall Technical Conference in early November in Bethesda, Maryland, Perrigo Regulatory Affairs Senior Director Keith Webber commented on the positive impact that the broad participation is having on the Q12 effort. He represents IGBA on the EWG and served as moderator of the conference session.

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