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.
The four stories in the August Monthly Update are centered around the dialogue that took place between regulators and industry at the mid-July CASSS CMC Strategy Forum on bioconjugates and multispecifics. In the IPQ coverage, experienced regulators and former regulators from Canada, Japan, Chile and FDA weigh in on the CMC issues that are presenting themselves in interfacing with sponsors and how they are being addressed. A common theme was the benefits of early engagement to help smooth out the development and clearance process, and the importance of international convergence to make the process – given the complexities involved – more manageable for all involved.
The three stories in the July Monthly Update (see pp. 4-45) provide insights from leading regulators on the CMC regulatory issues and developments for cell and gene therapies (CGTs). The first two focus on a regulatory session that concluded the June CASSS CGT conference, at which a panel of international regulatory leaders shed light on the strategies their respective agencies are pursuing to support the rapidly evolving CGT field and how these connect with broader regional and global convergence efforts. The third move to a June PDA Europe ATMP Conference, where EMA’s Dolça Rogers shared case studies elucidating two of the significant CMC problem areas that have been surfacing in regulatory filings for advanced therapy medicinal products (ATMPs) – potency testing and comparability. She also addressed the international activities underway to improve harmonization of approaches and alignment on regulatory decisions for ATMPs.
The stories in IPQ's June Monthly Update explore the formulation and analytical challenges facing industry, regulators and pharmacopeias in their efforts to advance the development of the next generation of therapeutics and biosimilars. In focus in the lead story are insights provided at a “Biologics Summit” on the challenges and innovation requirements in developing the next generation of mRNA-LNP therapeutics, which was held in conjunction with the May 2025 IPEC-Americas Excipient World (EW) conference. The first two of the three stories drawn from June Weekly Supplements involve presentations at the EW conference on how USP is adapting and refining its tools, strategies and standards to better support the more complex excipients and formulations needed across the advanced therapy landscape. The third Weekly story shifts to USP’s effort to address key challenges in global biosimilar development and regulation discussed at the June 2025 DIA Global Annual Meeting.
Included in the May Monthly are the five “regulator spotlight” stories that were featured in IPQ Weekly Supplements during the month. Drawing from presentations at recent conferences, the stories encompass: ● a review of ICMRA collaborative pilot learnings and next steps by EMA’s Kotzagiorgis and Cuddy ● the benefits for post-approval changes flowing from the Egyptian Drug Authority’s international reliance journey ● a discussion by MHRA’s Jackson of PIC/S training and harmonization goals ● MHRA’s data-driven compliance strategy for addressing a changing landscape, and ● insights on CMC regulatory considerations for individualized cancer immunotherapies from MHRA’s Wan.
The lead story in the April Monthly Update focuses on the industry/regulator discussions that took place at an October 2024 DIA/FDA oligonucleotide conference of how the knowledge gained in addressing the CMC challenges of mRNA COVID-19 vaccines can be leveraged in the therapeutics arena. Receiving attention were the tailored control strategies needed to address the challenges posed by the expanding diversity of mRNA therapeutic modalities. Also included in this issue are the four stories that were featured in IPQ Weekly Supplements during the month, which provide insights from leading regulators on: ● how the revised EU variation classification guideline will address the impact and risk of combination product changes ● Health Canada’s GMP inspection findings and shift toward a more risk-based collaborative framework ● African medicines regulatory harmonization and the milestone reached with the first continental listing of collaboratively reviewed products, and ● UK MHRA’s preparations to implement a new regulatory framework for decentralized manufacturing.
Included in the March Monthly are the four “regulator spotlight” stories that were featured in IPQ Weekly Supplements during the month. They encompass: ● a CASSS CMC Strategy Forum at which Health Canada’s Siggers reviewed data model challenges and regulatory experience/needs ● a UNICEF/UNEFPA/WHO meeting where light was shed on the CMC/GMP support WHO is providing for local medicine production ● a presentation by EMA’s Hernan on the Quality Innovation Group’s role, focus, and activities in advancing CMC technology, and ● the 2025 CASSS WCBP symposium at which a panel of global regulatory leaders explored the progress in convergence, reliance, collaboration, access, and biomanufacturing innovation, and how that progress can be furthered in the future.