To improve access to innovative medicines for patients with cancer and other serious diseases, Minister of Health Linas Kukuraitis has approved changes to the requirements and authorisation process for advanced therapy medicinal products (ATMPs) manufactured under the hospital exemption.
The changes will make it easier to produce innovative, patient-specific medicines and give doctors greater flexibility to choose the most appropriate treatment for each patient.
“Meeting patients’ needs is our priority, which is why we are working to improve access to innovative medicines for those who need personalised medical solutions. These changes expand the use of ATMPs: at a doctor’s request, medicines for specific patients will be able to include not only cell therapy and tissue-engineered products, but also gene therapy medicines,” said Deputy Minister of Health Daniel Naumovas.
Under the hospital exemption, ATMPs are manufactured on a non-routine basis using different or modified manufacturing methods, or at a different frequency from standard industrial production.
ATMPs are part of personalised medicine because they are selected and prescribed for individual patients based on their specific characteristics and clinical condition, particularly where registered medicines cannot provide effective treatment or are not available.
The approved changes establish clearer manufacturing requirements aligned with European Union (EU) rules. ATMPs will have to be manufactured in accordance with the specific EU good manufacturing practice requirements applicable to advanced therapy medicinal products.
The amendments also strengthen quality and safety requirements. Heads of healthcare institutions will be required to approve a quality documentation package for each ATMP and ensure its traceability, pharmacovigilance and ongoing monitoring of effectiveness.
The new framework will also help ensure continuity of treatment if an ATMP manufacturing authorisation is suspended. In such cases, treatment may continue and medicines manufactured before the suspension may still be supplied to the patient receiving treatment, where the expected clinical benefit is considered greater than the harm that could result from stopping treatment.
The changes will reduce the administrative burden on manufacturing institutions and the State Medicines Control Agency. Authorisations to manufacture ATMPs will be issued for an unlimited period, with different processing timelines depending on the type of authorisation.
The amendments, which are also intended to support the development of the biotechnology sector, will enter into force on 1 November 2026.
