On March 18, 2026, the European Parliament's SANT committee approved the text agreed at early second-reading interinstitutional negotiations on the EU General Pharmaceutical Regulation, procedure 2023/0131(COD). The procedure file published by the European Parliament Legislative Observatory now calendars an indicative plenary sitting for November 11, 2026, with entry into force expected in 2026 and applicability across all 27 EU Member States in 2028. The act repeals Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 on orphan medicinal products and Regulation (EC) No 1901/2006 on paediatric medicines, and amends Regulation (EC) No 1394/2007 on advanced therapy medicinal products and Regulation (EU) No 536/2014 on clinical trials. A sibling Directive, procedure 2023/0132(COD), is adopted in parallel and replaces Directive 2001/83/EC, the Community code for human medicines.
The file moved from Commission proposal on April 26, 2023 to a first-reading Parliament position on April 10, 2024 (488 to 67, 34 abstentions), into trilogue after June 3, 2025, to political agreement on December 11, 2025 and COREPER endorsement on March 6, 2026. The SANT committee vote on March 18, 2026 locks the early second-reading text that the plenary is expected to ratify on November 11, 2026.
What changes for marketing authorisation holders and the EMA?
The European Medicines Agency's human-medicines committees are reduced from five to two: the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC). The scientific assessment timeline is compressed from 210 to 180 days, and the Commission decision step from 67 to 46 days. A centrally granted marketing authorisation becomes valid for an unlimited duration by default, eliminating routine five-year renewals. Baseline regulatory data protection is set at eight years, with a one-year extension available when the product launches in all Member States where it is authorised, capped at eleven years total.
The Agency must separate the staff providing scientific advice to a developer from the staff later evaluating that developer's marketing authorisation application, with at least one of the two rapporteurs for any application barred from prior pre-submission activities on the same product. A new European medicines web-portal, maintained by the Agency, will publish safety, efficacy, environmental risk, shortage and pending-obligation information for every centrally authorised product.
What new incentives apply to antimicrobials and orphan drugs?
To address the antimicrobial resistance market failure, the regulation introduces a transferable data exclusivity voucher for "priority antimicrobials". The Commission may grant a voucher, on an Agency scientific assessment, giving its holder an additional 12 months of regulatory data protection for one centrally authorised product. The voucher is single-use, applies only to a product within its first four years of regulatory data protection, and cannot stack on a product already at the maximum protection period. Pathogen eligibility follows the WHO priority pathogens list: 12 months for "critical" rank, 9 months for "high" and 6 months for "medium". The Commission must deliver an evaluation report on the voucher's effectiveness five years after entry into force.
For orphan medicinal products, the standard market exclusivity becomes nine years, with a one-year extension tied to patient access in all Member States concerned and an uplift to 11 years for products addressing a high unmet medical need. Within 24 months of entry into force, the Commission must propose a Union Framework for Rare Diseases to coordinate Union policies and programmes on rare diseases.
What shortage-prevention duties are introduced?
Marketing authorisation holders must notify and explain any decision to temporarily suspend the marketing of a medicinal product in a Member State no less than six months before the suspension starts. The Agency is empowered to monitor shortages of centrally authorised products, based on holder notifications, and to publish that information on the European medicines web-portal. When a critical shortage is identified, national competent authorities and the Agency must coordinate public communication on estimated duration and alternatives. The act formalises a Union-level shortage prevention and security-of-supply framework, sitting alongside the EMA extended-mandate rules from Regulation (EU) 2022/123.
Who must act, and by when?
| Milestone | Date | What it triggers |
|---|---|---|
| SANT committee approval of agreed early second-reading text | March 18, 2026 | File locked for plenary ratification |
| Council position (first reading, expected) | March 25, 2026 | Final co-legislator alignment |
| Indicative plenary sitting | November 11, 2026 | Parliament adoption of the joint text |
| Entry into force (expected) | 2026, after OJEU publication | Delegated and implementing act mandates open |
| Applicability | 2028 | New authorisation, data protection and shortage rules apply to live dossiers |
The official source for these milestones is the European Parliament Legislative Observatory procedure file 2023/0131(COD), with the Commission proposal at COM(2023) 193 final and the first-reading position at Text adopted T9-0221/2024.
Take advantage of this real-time watch
Regulatory affairs and CMC teams at marketing authorisation holders should map their centrally authorised portfolio against the new eight-year data protection baseline, the unlimited-validity default and the orphan exclusivity uplift; rare-disease and antimicrobial R&D leads should evaluate eligibility for the transferable data exclusivity voucher and the 11-year high-unmet-need orphan exclusivity; and shortage leads should re-engineer discontinuation workflows to the six-month notice. Track the November 11, 2026 plenary sitting and the 2028 applicability date through a continuous, per-jurisdiction monitoring routine, the kind of change Obsidian surfaces the moment a procedure file is updated.
