First EU Joint Clinical Assessment Report Published

The European Medicines Agency’s Management Board met in Amsterdam on 10 and 11 June 2026. The European Commission reported that the first EU joint clinical assessment report appeared on 9 June 2026. Since the Health Technology Assessment Regulation took effect in January 2025, 18 JCAs have started. Seven Joint Scientific Consultations have finished under the Regulation, and the first JCAs for medical devices and in vitro diagnostics will begin in June 2026.

Source: EMA Management Board minutes, 132nd meeting, EMA/MB/134603/2026.

First EU joint clinical assessment report published

The first JCA report appeared on 9 June 2026. Since the Regulation became applicable in January 2025, 18 Joint Clinical Assessments have started and seven Joint Scientific Consultations have finished. The Commission noted that JCAs for medical devices and in vitro diagnostics will start in June 2026.

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Manufacturers and health technology developers now face a single scientific assessment that Member States can use instead of separate national submissions. Questions remain about how uniformly national HTA bodies will apply the joint reports and how fast the number of JCAs will grow across different therapeutic areas.

EMA fees update from January 2027

The Board heard that a Delegated Act will adjust EMA fees to match inflation rates recorded for 2023 to 2025. The new fees will take effect in January 2027 and will cover specific provisions for veterinary medicines. The update follows the Fee Regulation adopted in 2024 and aims to keep fees in line with actual costs instead of a fixed timetable.

Critical Medicines Act heads for a union list

The Commission stated that a political agreement on the Critical Medicines Act was reached on 12 May 2026. Work now centres on adopting a Union list of critical medicines by the end of 2026 and on vulnerability assessments by the Executive Steering Group on Shortages and Safety of Medicinal Products. Those assessments will support public procurement preferences, funding priorities for strategic projects, and joint purchasing across Member States.

New pharmaceutical legislation and the Biotech Act

The new pharmaceutical legislation has been agreed by the co-legislators and is due for publication around November 2026. It will enter into force soon after publication and apply in full two years later. Some measures, such as the regulatory sandbox, vouchers, security of supply rules, international cooperation, and grants, will apply from the date of entry into force.

A Commission Staff Working Document on the Biotech Act was published on 26 May 2026. The Council is expected to adopt a position on the Directive on 16 June and on the Regulation by the end of the year, with trilogues planned for the first half of 2027. The Act also creates a new category of minimal-intervention clinical trials to ease the requirements for low-risk studies. Regulatory reforms are expected to strengthen European biotech competitiveness.

The Board received an update on the revision of the medical devices and in vitro diagnostics legislation. The Council aims for a general approach by December 2026, and the European Parliament is expected to set out its position in July. The Commission also reported on an EMA pilot for breakthrough medical devices and the mandatory use of four EUDAMED modules from 28 May 2026.