QYOBO Research - EU pharmaceutical reform

As of 23 September 2026, European Parliament procedure records for the pharmaceutical Regulation and Directive reported that both were awaiting the Council’s first-reading position. Council notes proposed adoption of those positions at a forthcoming meeting. The September Council texts concern human medicines.

The Regulation covers EU authorisation, supervision, supply security and European Medicines Agency governance; the Directive covers placing medicines on the market, manufacturing, trade, distribution, safety monitoring, advertising and control. This summary describes those texts, rather than obligations already applicable under the reform. 1, 2, 3, 4, 5, 6

The bracketed labels identify the medicines directly concerned; for protection periods, they identify the medicines receiving that protection. They are navigation aids, not exhaustive legal definitions, and exclude indirect effects on competitors; the conditions and exemptions described still apply.

What the texts provide

[All drugs – centralised approvals]
The centralised approval route can cover applications referring to a centrally authorised reference medicine, as well as originator medicines, subject to eligibility requirements. The Regulation would allow 180 days for the scientific opinion on a valid application, with an extension possible where justified. This period concerns the scientific assessment, not the total time until a medicine is commercially available or reimbursed. Ordinary central marketing authorisations would generally remain valid without a time limit, although safety grounds could justify limiting initial validity to five years. 5

[Originator/reference drugs]
The Directive would provide eight years of ordinary data protection, followed by one year of market protection. During data protection, another applicant cannot rely on the protected information submitted for the reference medicine. Market protection then restricts when a subsequent medicine can be placed on the market, even after data protection has expired. These protections are distinct from patents and supplementary protection certificates. 6

[Originator/reference drugs]
An additional year of market protection would be available for medicines meeting the unmet-medical-need criteria or the specified alternative requirements for clinical evidence and filing. A further year could be awarded once for a qualifying new indication, meaning an additional approved use, authorised during data protection. Reference medicines whose applications were submitted before the new rules generally apply would retain their existing ordinary protection regime. 6, 5

[Generics, biosimilars and other qualifying applicants]
The intellectual-property exception would permit qualifying preparatory work for authorisation, health technology assessment, pricing and reimbursement, including relevant work by suppliers and service providers. It would also cover tender applications within specified limits, excluding sale or offers for sale during patent or supplementary-protection-certificate protection. The exception would not allow the resulting medicines to be placed on the market. 6

[Orphan drugs]
Orphan medicines would ordinarily receive nine years of market exclusivity, or eleven for qualifying breakthrough products. Those approved through the specified bibliographic route would receive four years. That route uses scientific literature instead of new test and trial results where the requirements for well-established use and other eligibility conditions are met. Qualifying standard and breakthrough orphan medicines could receive an additional year twice for different orphan conditions, subject to timing and eligibility requirements. 5, 6

[Priority antimicrobials and voucher users]
A qualifying priority antimicrobial could receive a voucher extending data protection for one authorised medicine by twelve months, subject to eligibility, supply and other conditions. The voucher could be transferred once and used once for a single centrally authorised medicine; using it for another medicine would carry additional restrictions. The scheme would stop issuing vouchers after five had been issued or fifteen years from entry into force, whichever came first. 5

[Protected drugs – including orphan medicines]
A Member State could request that a protected medicine be made available and supplied in its territory. This could involve an application for pricing and reimbursement, specified procurement requirements or an agreed plan for supplying the medicine over time. If the defined supply failure occurred, regulatory market protection and the specified orphan exclusivity extension could cease to apply in that country, subject to the mechanism’s conditions and exceptions. This would not remove all intellectual-property rights. 6

[All drugs – prescription and other designated medicines]
Marketing authorisation holders would need shortage-prevention plans for prescription medicines and other designated products, including those authorised before general application. They would have to submit a requested plan within two days of receiving the request. Plans would identify where medicines are manufactured and each site’s share of production at different manufacturing steps, together with vulnerabilities and dependencies. Member States could grant specified exemptions from listed supply-security obligations, including defined national-security and defence cases; their scope differs by obligation. 5

[All drugs]
Permanently ceasing the marketing of a medicine in a Member State, or requesting withdrawal of the marketing authorisation, would require notification at least twelve months before the last supply in that country. An expected supply disruption lasting more than two weeks would require at least six months’ notice. Where exceptional circumstances prevented that disruption notice, the holder would need to substantiate them; the specified Member State exemptions would also remain relevant. 5

[All drugs – antimicrobials only]
Environmental assessment would have to examine the risk of antimicrobial resistance selection in the environment across the entire manufacturing supply chain, including sites outside the EU. 6

[All drugs – chemical active substances]
The Directive would provide a European Medicines Agency certification route for active substance master files, which contain the required information about a chemical active substance. Certificates would be valid throughout the EU, with continuing obligations for their holders. The text retains alternative ways to provide the required information, subject to conditions; certification would not be mandatory for every active substance. 6

[All drugs – funding disclosure]
Marketing authorisation holders would have to publicly report specified direct public, philanthropic and nonprofit funding for research and development, with independent auditing of that reporting. Transitional exemptions would apply, so this would not be a blanket requirement to report funding retrospectively for all existing medicines. 6

[All drugs]
Package leaflets would be available in paper and electronic form. Member States could choose electronic-only provision, provided a free printed copy was available on request. Implementing standards and different transition rules for products would still apply. 6

When the rules would apply

Both instruments provide for entry into force twenty days after Official Journal publication. The Regulation would generally apply twenty-four months after entering into force. Member States would have to incorporate the Directive into national law and apply it twenty-four months after its entry into force. The Regulation’s critical-medicine provisions would apply from entry into force, while the shortage provisions would apply six months later. Member States could apply the country-access mechanism from twelve months after the Directive enters into force for medicines authorised after its entry into force. 5, 6

Two practical pointers for companies

Recommendation 1: Check how the rules affect each product’s protection periods and launch plans. For each product, record when the application was submitted, which protection regime applies and whether it qualifies for an extension. Keep those records alongside Member State requests to make the medicine available and any associated supply commitments. Build a calendar from publication and entry into force, recording national implementation and the earlier dates for country-access and supply provisions separately. 6, 5

Recommendation 2: Make sure you can explain where your medicines are made and respond to requests about supply. Identify who maintains shortage-prevention plans and who is responsible for meeting notification deadlines. Gather the manufacturing locations, each site’s production share and the dependencies between manufacturing steps, with the information ready for a requested plan. For antimicrobials, include overseas sites when requesting environmental information from suppliers and assessing resistance-selection risks throughout the manufacturing chain. 5, 6