Germany Adapted AMNOG Dossier Rules to Work Alongside EU Joint Clinical Assessments

Under Germany’s AMNOG procedure, companies launching a medicine with a new active substance submit a benefit dossier to the G-BA, which commissions the Institute for Quality and Efficiency in Health Care (IQWiG) to assess it before deciding on the extent of added benefit. Since 12 January 2025, new cancer medicines and advanced therapy medicinal products have also been subject to EU joint clinical assessment under Regulation (EU) 2021/2282, so that some products now go through both an EU and a national process.

The Federal Ministry of Health described its amendment of the AM-NutzenV as a first, limited step for an introductory phase. The ordinance, dated 4 March 2025, was published in the Federal Law Gazette (BGBl. 2025 I Nr. 75) on 7 March 2025. It sets out how information submitted at EU level is brought into the national procedure, including that the G-BA makes the EU dossier available for comment alongside the national benefit assessment.

On 17 July 2025 the G-BA amended Chapter 5 of its Rules of Procedure in response to the EU HTA Regulation and the amended ordinance. In its press release, the G-BA described the step as linking the European assessment with the national early benefit assessment. Companies may refer to information submitted in the EU dossier instead of submitting it again nationally, and the G-BA noted that it retains no obligation to investigate on its own initiative. IQWiG is to take the EU joint clinical assessment report into account in its national assessment.

A further G-BA decision of 20 November 2025 made corrective amendments, including to annexes of the Rules of Procedure. The G-BA has stated that the first benefit assessments following a prior EU assessment were expected to begin in spring 2026, based on the adjusted procedural rules and the dossier modules. Whether specific dossier modules were revised for these cases could not be confirmed from the sources reviewed.

The amended ordinance responded to a practical question that arises when the two procedures overlap: whether a company must submit the same clinical evidence twice. By allowing reference to the EU dossier and providing for it to be made available for comment, the ordinance aims to reduce duplication while keeping the national procedure intact. The Ministry’s draft described the adjustments as slight and intended for an introductory phase, which indicates that further changes may follow as experience grows.

The Medical Research Act (Medizinforschungsgesetz) of 2024 amended pricing and reimbursement law. Secondary sources report that it introduced an option for companies to keep the reimbursement amount resulting from AMNOG negotiations confidential, and that it revised the pricing guardrails introduced in 2022. These changes affect negotiation rather than the content of the benefit dossier, and their details should be checked in the law text.

In September 2026 a broader AMNOG reform was under discussion. The G-BA, in a statement dated 16 September 2026, raised questions about provisional patient-relevant endpoints and about the role of the appropriate comparator therapy, and stated that real-world data cannot replace a regular benefit assessment. The statutory health insurers’ association (GKV-Spitzenverband) commented on 18 September 2026 on a draft described as AMNOG 2.0, and the research-based industry association vfa presented its own proposals on 22 September 2026. The government’s draft text had not been reviewed for this brief.

Companies with products in the scope of EU joint clinical assessment should plan the EU and national dossiers together. The EU dossier addresses the PICOs set by Member States, while the national dossier must still address the comparator therapy set by the G-BA and German-specific questions on patient-relevant outcomes and subgroups. Where the EU dossier already contains the required information, a reference can reduce duplication.

Companies should also follow the outcome of the 2026 reform discussions, which could change evidence requirements and the treatment of the comparator. Pubrica’s summary is for information and is not legal advice; it does not represent the views of the G-BA, IQWiG or the Ministry.