- Funding Programme
- Year
- 2023
Strengthening the Capacity of the State Medicines Control Agency in Lithuania
The European Commission successfully enhanced the capacity of the State Medicines Control Agency (SMCA) to address systemic challenges in health technology assessments (HTA), national scientific advice (SA), and Good Manufacturing Practice (GMP) inspections of complex biological medicinal products.
Context
Prior to the project, the SMCA faced a significant HTA backlog with assessments averaging 500 days, far exceeding the 90-day mandate, and acute resource constraints in GMP inspections, where only two inspectors managed 27 licences. The emergence of innovative Advanced Therapy Medicinal Products (ATMPs) and the implementation of the EU HTA Regulation (2021/2282) created an urgent need for specialized expertise and a streamlined regulatory framework to ensure timely patient access to life-saving medicines.
Support Delivered
Between December 2023 and February 2026, the SMCA and the Ministry of Health received technical support from the provider. The project delivered 11 technical reports, including a comprehensive HTA toolkit (Critical Self-Appraisal Checklist, Scoping Recommendations, and Capacity Planning Tool) and specialised GMP guidance for biologicals. Capacity building featured an advanced two-day HTA training for 12 specialists and a full-cycle simulated (shadow) inspection at the local biotechnology company to operationalize the existing inspection procedures for ATMPs for new specialists.
Result achieved
The project institutionalized a modern HTA methodology that prioritizes national resources on cost-effectiveness while leveraging Joint Clinical Assessments for clinical evidence. Key outcomes include the validation of HTA guidelines through shadow assessments of complex medicinal products and the successful onboarding of new GMP personnel through practical field testing. These steps have positioned the SMCA as a competent and constructive regulatory partner, equipped to reduce assessment timelines, eliminate backlogs, and meet the requirements of the evolving European regulatory architecture.
More about the project
You can read the documents related to the project here: