At the 2025 CASSS Cell and Gene Therapy Products (CGTP) Symposium, held in Rockville, Maryland in early June, 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.
At the 2025 DIA Global Annual Meeting, held in Washington, DC in mid-June, USP International Government and Regulatory Engagement Director Chaitanya Koduri provided an update on USP’s efforts to address key challenges in global biosimilar development and regulation. After introducing USP and biosimilars, he discussed current challenges to their adoption and the role of advanced analytical tools in reducing the need for clinical data. Koduri then shared insights from a 2024 global regulatory consultation on biosimilar standards, the findings of which are helping shape USP’s strategy for supporting biosimilar development, standardization and harmonization.
At the 2025 IPEC-Americas Excipient World Conference, held in Maryland in mid-May, USP Senior Director for Global Science and Standards in Foods and Excipients Catherine Sheehan reviewed USP’s emerging/evolving approaches for addressing: ● excipient quality challenges ● phospholipid standards and solutions for complex injectables, and ● novel excipients and CGTs. In talks the next day, Sampada Kharade spotlighted USP’s engagement with the challenges of LG polymers, and Katie McGowan focused on USP’s Donations Program and how it supports excipients not yet covered by compendial standards.
Reflective of the important role that pharmacopeial standards and guidance play in quality regulatory processes around the world, IPQ will now be including key presentations by pharmacopeial leaders at recent conferences to the coverage of regulator insights in our Weekly Supplements.
At the 2025 IPEC-Americas Excipient World Conference, held in Maryland in mid-May, USP Senior Manager for Excipients Hong Wang reviewed USP’s evolving excipient strategies and recent standards initiatives. Her presentation covered: ● an introduction to excipients and the USP excipient strategy ● the excipient nomenclature guideline ● evolving/iterative approaches, and ● USP’s “Flexible Solution: Materials Program.”
At the “regulatory considerations” session of the CASSS/AMM mRNA symposium, held in Gaithersburg, MD in late May 2025, Medicines and Healthcare Products Regulatory Agency (MHRA) Senior Pharmaceutical Assessor Ka-Wei Wan provided an overview of MHRA’s engagement with individualized mRNA cancer immunotherapies, with a focus on the CMC issues involved. After outlining developments in the mRNA field, she discussed the draft guidance that MHRA released on the regulatory considerations for individualized mRNA cancer immunotherapies. She then highlighted the comments received on the draft and some of the next steps MHRA will be taking to facilitate product development and the regulatory interface.
At the 2025 Making and Distributing Pharmaceuticals conference held in Coventry, UK, in late April, MHRA Expert GDP Inspector Peter Brown reviewed: • MHRA organizational developments • recent regulatory reforms • the future outlook for the agency • compliance trends • case studies on falsified medicines and poor data governance, and • industry trends and challenges.
At the ISPE Europe 2025 Annual Meeting held in London in mid-May, MHRA Expert GMP Inspector Ian Jackson gave a presentation on behalf of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), outlining its work on “quality, standards, capability, harmonization, confidence, and collaboration.” He discussed: ● the background to PIC/S ● PIC/S’ role in GMP harmonization, and ● PIC/S’ strategic plan and future directions.
In a March 2025 webinar jointly sponsored by EFPIA, EUCOPE, EuropaBio, IFPMA, and Vaccines Europe, Egyptian Drug Authority’s Asmaa Fouad shared EDA’s “story of trust and transparency” in establishing reliance practices and the benefits that have been realized for post-approval changes. EMA’s Emer Cooke and Martin Harvey gave opening and closing remarks, respectively, in which they stressed the global importance of reliance tools and the key role EMA plays in sharing assessment outputs.
The International Coalition of Medicines Regulatory Authorities (ICMRA) has extended its two regulatory collaborative pilot programs – the Collaborative Assessment Pilot (CAP) and the Collaborative Hybrid Inspection Pilot (CHIP) – and will continue to accept applications until the end of 2025. At the DIA Europe Conference session on “global partnerships to accelerate availability of quality medicines” held in Basel in March 2025, EMA leaders discussed the latest ICRMA Pilot updates, key learnings, and future directions. EMA Quality Specialist Evangelos Kotzagiorgis focused on the CAP initiative and EMA Lead Scientific Officer Brendan Cuddy reviewed CHIP.
In a late January 2025 webinar on “Modular Manufacturing and Point-of-Care Regulations,” Medicines and Healthcare Products Regulatory Agency (MHRA) leaders discussed the new regulatory framework to support decentralized manufacturing (DM) that comes into force in the UK in July 2025.
MHRA Inspectorate Strategy and Innovation Unit Manager Ian Rees covered: • MHRA responsibilities, mission and vision • an overview of the new DM framework • manufacturing technology models • the new legislation, and • international and institutional perspectives. Expert Pharmaceutical Assessor Elspeth Gray followed with a discussion of: • the qualifying tests that define eligibility for decentralized manufacturing, and • the DM master file. Rees returned to discuss future steps, including guidances, workshops, and international collaborations.