Quality Risk Management

Revised procedure for coordinating GMP inspections of centrally authorised products

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Version 3 of the guideline, adopted in April 2026 and entering into force on 10 September 2026, describes EMA coordination of GMP inspections conducted by EEA competent authorities for centrally authorised products. It covers pre-approval inspections, for-cause inspections and routine risk-based re-inspections, including inspection triggers, authority selection, preparation, site contacts and report submission through IRIS. The revision clarifies that, where a Supporting Authority is unnecessary, one Authority may perform both leading and supporting roles. Applicants should identify proposed manufacturing, testing and batch-release sites before submission, and all listed sites should be inspection-ready and compliant with EU or equivalent GMP from submission.

EMA Guidance on Implementing Shortage Prevention Plans

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EMA issued guidance describing how marketing authorisation holders should establish, maintain and update Shortage Prevention Plans for prescription-only human medicines in EU/EEA countries. Plans may group products sharing a supply chain, provided product-level minimum data can be supplied within two days of a request. The guidance sets out product information, patient-impact assessment, supply-chain mapping, shortage history, risk classification and proportionate management measures. It also identifies additional crisis-related information for listed critical medicines, including production and supply capacity, alternative sites and minimum stock levels. Plans should be updated after relevant changes and may form part of annual product quality review.

2024 PDA/FDA Conference Focuses on Effective Quality Systems

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FDA and the Parenteral Drug Association (PDA) will host the 33rd Joint Regulatory Conference on September 9–11, 2024, emphasizing effective quality systems and an ongoing state of control across the product lifecycle. The program focuses on robust quality systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management as foundations for CGMP compliance. It will use case studies to address sustainable compliance, quality and supply consistency, and international collaboration. Planned discussion topics include investigations, cybersecurity and data integrity risks, supplier selection and auditing, current manufacturing technologies, CGMP guidance updates, aging facilities, quality assurance authority, and quality-control laboratory risk reduction.

FDA and PDA Announce 2026 Joint Regulatory Conference

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FDA and the Parenteral Drug Association (PDA) will host the 2026 PDA/FDA Joint Regulatory Conference, “Excellence in CGMP: Ensuring Quality, Protecting Patients,” in Washington, D.C., from September 14 through 16, 2026. The program is intended to provide practical insights on CGMP compliance, quality systems, risk-based manufacturing, supply chain oversight, and industrial modernization through expert discussions and case studies. Listed subjects include FDA center and office updates, artificial intelligence in regulatory oversight and inspection readiness, pre-approval inspections, CAPA and effectiveness checks, data governance, quality risk management, change management, workforce development, CGMP training, and global regulatory collaboration. Registration and a full agenda are available through PDA.