At a late March meeting of the African Medicines Regulatory Harmonization (AMRH) Steering and Technical Committees, a press briefing was held to announce the first continental listing of medicinal products that have undergone assessment and inspection by African regulators and highlight its significance as a milestone in the AMRH effort to enable more efficient approval timelines and faster access to African patients.
At the 2025 University of Georgia/FDA International GMP Conference, held on the UGA campus in early March, Health Canada GMP Inspection Regional Manager Magda Joseph reviewed the compliance and enforcement activities of the agency’s Regulatory Operations and Enforcement Branch (ROEB). She provided: ● an introduction to ROEB’s mandate, structure and activities ● an overview of GMP trends from an HC perspective, with particular emphasis on Annex 1 and foreign facility compliance, and ● an update on key initiatives, including mutual recognition agreements (MRAs), international collaborations, and artificial intelligence.
At the 2025 DIA/RAPS Summit on Combination Products in the EU, held in Brussels at the end of January, EMA Procedures Office Head Virginia Rojo gave an update on the agency’s ongoing efforts to support companies in dealing with lifecycle management of combination products (CPs). She discussed the relationship between the current CP guidance and the draft variation classification guidance, and the increased focus on assessing the risk and impact of changes to the medicinal product.
A panel session at the 2025 CASSS WCBP Conference brought together international regulatory leaders to discuss “navigating the regulatory landscape: global convergence and innovation in biopharmaceutical manufacturing.” Participating in the panel discussion were Japan PMDA’s Yasuhiro Kishioka and Akihiro Ishiguro, EMA’s Anabela Marçal, Swissmedic’s Claudia Müller, Health Canada’s Sophie Sommerer, and WHO’s Rogério Gaspar.
The panelists began by explaining the roles their departments play and the structure, mission, key priorities, and recent regulatory and legislative initiatives of their respective agencies and WHO. The Q&A that followed allowed the panelists to further explore: ● inter-agency collaborations between EMA, FDA, and other agencies ● the Access Consortium and assessment of CGTs ● the role of PMDA’s new office in Washington DC ● initiatives to support innovation in manufacturing and technology ● interactions between reviewers and inspectors ● information sharing through Accumulus and other IT platforms ● learnings from and evolution of the ICMRA assessment pilots, and ● alignment on platform technology designations.
At the 2025 IFPAC meeting, held in Bethesda, Maryland, in early March, EMA Senior Quality Specialist Dolores Hernan reviewed the role and activities of EMA’s Quality Innovation Group (QIG) in helping foster the flexibility, clarity, and global convergence in regulatory expectations and processes needed to support technological progress in the CMC arena.
At the 2024 UNICEF/UNFPA/WHO Manufacturers and Suppliers Meeting held in UN City Copenhagen in early December, members of WHO’s Local Product & Assistance (LPA) Unit provided insights into the unit’s technical assistance program. The TA program supports manufacturers in achieving compliance with international regulatory norms and standards in order to obtain WHO prequalification status for a medical product. The feature story in this Weekly Supplement focuses on the presentation at the meeting by Kim Notenboom, who was then completing a two-year assignment to the LPA Unit. She returned in January to the Dutch Medicines Evaluation Board, where she serves as a senior quality assessor and drug shortages expert. Included in her talk were case studies illustrating how WHO assists in meeting CMC and GMP expectations.
At the CMC Strategy Forum North America, held in Washington DC, in late January 2025 in conjunction with the CASSS WCBP Conference, Health Canada Biologics and Radiopharmaceutical Drugs Directorate (BRDD) Senior Evaluator Jayda Siggers reviewed the expectations and challenges of using predictive data models to support marketing authorizations in the CMC arena. Her presentation covered: ● the types of data models submitted to Health Canada to date ● a case study involving the use of process capability and stability models for a monoclonal antibody submission ● reflections on lessons learned on model use ● a review of the regulatory expectations for data models, including filing requirements, and ● key takeaways.
At the JPAG Regulatory Hot Topics IX Symposium, held in London, UK, in December 2024, MHRA Head of New Active Substances - Innovative Medicines Bassel Odeh explored the progress of the ICH Expert Working Group (EWG), of which he is a member, in revising and modernizing the Q6A and Q6B guidelines on the specifications for drug substances and drug products and the principles guiding the effort.
At the 2024 ISPE Pharma 4.0 & Annex 1 Conference held in Rome, Italy in December 2024, Ireland Health Products Regulatory Authority (HPRA) Executive Pharmaceutical Assessor Nick Lee provided an update on the EMA Quality Innovation Group (QIG) initiatives concerning pharmaceutical process models. He reviewed: ● the background on the QIG work, including the draft guidance on “Preliminary QIG Considerations on Pharmaceutical Process Models” ● process model risk analysis, and ● documenting data in the dossier.
Manufacturers need to leverage strategic data management to maintain process stability and foster optimization of sterile manufacturing, Austria Agency for Health and Food Safety’s Ronald Bauer and Christina Meissner stressed in their joint presentation at the 2024 ISPE Pharma 4.0 & Annex 1 conference, held in Rome, Italy, in December 2024. Bauer began by reviewing the general regulatory expectations for data governance, including: ● the development of a validation strategy ● risk analysis ● ensuring data integrity, and ● using data for process optimization. Meissner then addressed applying these principles to sterile manufacturing, focusing on data sources in sterile manufacturing and the contamination control strategy of Annex 1. Bauer then returned to the podium to impart some key take home messages.