The European Medicines Agency (EMA) announced on 15 July 2026 that its Committee for Medicinal Products for Human Use (CHMP) adopted 26 scientific advice and protocol assistance procedures during its meeting from 22 to 25 June 2026. The procedures cover a wide range of therapeutic areas, including advanced therapies for acute myeloid leukaemia (AML), multiple myeloma, and Pompe's disease, as well as biological treatments for conditions such as beta-thalassaemia intermedia, soft tissue sarcoma, and SARS-CoV-2 infection prevention.
The document, published by EMA's Press Office on 25 June 2026 under reference EMA/163533/2026, provides a detailed breakdown of the adopted advice. Among the 26 procedures, 15 were new scientific advice requests, 5 were follow-ups to scientific advice, 4 were new protocol assistance requests, and 2 were follow-ups to protocol assistance. The topics addressed include quality, preclinical, clinical, and significant benefit assessments. Notably, several advanced therapies received advice on clinical development plans, including treatments for inflammatory myopathies, geographic atrophy, sickle cell disease, and mantle cell lymphoma.
The EMA's scientific advice and protocol assistance procedures are designed to help developers optimise their clinical trial designs and regulatory strategies, potentially accelerating patient access to innovative medicines. The June 2026 CHMP meeting outcomes reflect the agency's continued support for novel therapies, including those targeting rare diseases and unmet medical needs. The cumulative totals since 1995 show 7,415 scientific advice procedures, 1,607 protocol assistance procedures, and 272 qualifications of novel methodologies, underscoring the EMA's long-standing role in facilitating drug development.
Stakeholders impacted include pharmaceutical companies developing advanced therapies and biologics, which benefit from early regulatory guidance but face the administrative burden of preparing comprehensive submissions. Patients with conditions such as AML, Pompe's disease, and sickle cell disease stand to gain from potentially faster access to innovative treatments. Healthcare systems may see improved treatment options, though the high cost of advanced therapies could strain budgets. The EMA itself continues to manage a growing workload, with 497 procedures in 2026 alone, requiring sustained resources and expertise.