The feature story in this IPQ January-March issue focuses on the valuable insights offered by leading experts at the 2026 CASSS WCBP conference on how appropriately structured CMC submissions can enable cross-agency data comparability and shared analytics, drive streamlined marketing authorization and PAC assessments, and expand the potential for regulatory collaboration and reliance. They explained where the current CMC regulatory challenges lie and what is being done through ICH M4Q(R2) and M16 to address them. Included is the substantive discussion that followed at the session and a bibliography highlighting the wealth of coverage IPQ has provided since 2010 on the progress of this international collaboration journey.

The feature story in this monthly issue focuses on the ideas offered by EFPIA’s biomanufacturing team members at the October 2025 CASSS CMC Strategy Forum Europe for streamlining and harmonizing the CMC expectations in Europe and globally – in particular, for: ● ADCs ● the use of platform approaches and drug master files ● polysorbate control ● manufacturing site technology transfer, and ● subcutaneous formulations. Also highlighted in the story is the comprehensive 22-page position paper on “Science and Risk-based Approaches for the Classification of Post-approval Changes (PACs) for Advanced Therapy Medicinal Products (ATMPs) in the EU,” which EFPIA published in December.

The feature story in IPQ’s Monthly Update for November (see pp. 4-36) focuses on insights from two prominent FDA inspection experts on why data integrity (DI) failures continue to surface across the product life cycle and how to build more resilient governance systems that prevent them. In a DI-focused session at the 2025 PDA Regulatory Conference, industry consultant Peter Baker, a former FDA investigator with broad international experience, and CDER veteran compliance official Carmelo Rosa reflected on their deep engagement with data management across pharmaceutical manufacturing operations and the quality and regulatory consequences that ensue when data handling systems are inadequate.

The five stories in the September/October 2025 Monthly Update provide a deep dive into the issues that have been on the front burner in FDA’s recent efforts to assure the quality of drugs, biologics, and vet medicines. In focus is the light shed on them by agency compliance and inspection leaders at the September PDA Regulatory Conference.

Following individual updates by compliance leaders from FDA’s centers for drugs, biologics, and veterinary medicine and the new cross-center inspection office at the closing day plenary session of the September, 2025 PDA Regulatory Conference, they participated together in a panel discussion that further explored some of the key operational and policy concerns impacting the agency’s evolving oversight model. Receiving attention were: ● the center/field reorganization ● artificial intelligence (AI) ● pre-approval inspections (PAIs) ● inspection site selection models ● unannounced foreign inspections ● xenotransplantation animals ● warning letter trends, and ● the rise in vet drug enforcement actions.

In the morning plenary session on the concluding day of the September 2025 PDA Regulatory Conference, CBER, CDER and CVM compliance office leaders and the acting director of the Office of Human and Animal Drug Inspectorate (OHADI) shed light on the current regulatory processes, priorities and enforcement outlook across their respective programs.