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Where the Critical Medicines Act stands in November 2026
The European Commission proposed the regulation on 11 March 2025. The Council agreed its position on 2 December 2025 and the European Parliament adopted its own on 20 January 2026. The two reached a provisional agreement on 12 May 2026.
Coreper endorsed the agreed text on 30 June, and Parliament's public health committee approved it on 14 July. Parliament's Legislative Observatory gives 23 November 2026 as the indicative plenary date. Council adoption and publication in the Official Journal come after that. We quote article numbers from the Council's compromise text, and they may change in the final version.
What it says about manufacturing capacity in the EU
Strategic projects are the core of the act. Under Article 5, a project in the EU that creates, upgrades or expands manufacturing capacity qualifies if it meets at least one criterion. It can make critical medicines or their active substances, modernise an existing site, make key inputs, or help roll out in the EU a technology that is key to producing them.
Article 3 defines key inputs as materials other than the active substance that are needed to manufacture a medicine, including immediate packaging, excipients, solvents, reagents and starting materials. Its examples of innovative manufacturing processes include continuous manufacturing, decentralised manufacturing, platform technologies, AI and 3D technologies.
The benefits are faster paperwork and funding. The authority each country designates must decide within 20 days whether a project is strategic (Article 6). The national medicines authority must prioritise GMP inspections of the project's new, expanded or modernised sites (Article 11). Member states may prioritise financial support for projects that address an identified supply chain vulnerability (Article 15).
Is the Critical Medicines Act already law?
Not yet. The text was agreed on 12 May 2026 and Parliament's plenary vote is provisionally set for 23 November, ahead of Council adoption and publication in the Official Journal. Under Article 31, it will apply from the first publication in the Official Journal of the Union list of critical medicines.
Public procurement that looks beyond price
Article 18 requires public buyers of critical medicines to apply resilience requirements, which must support more diverse sources of active substances and reward reliable suppliers. Buyers can apply them as selection criteria, technical specifications, best price-quality ratio or contract performance clauses.
Where a medicine depends heavily on one or a few non-EU countries, buyers must favour EU manufacturing through at least one of two mechanisms. One is reserving a lot covering at least 50% of the volume for suppliers offering the medicine and its active substance made in the EU. The other is scoring bids in proportion to the share made in the EU. Import, repackaging, labelling and quality testing do not count as manufacturing.
The line that price can no longer be the only criterion came from Parliament's rapporteur, Tomislav Sokol, and reflects Parliament's position of January 2026. The agreed text allows justified exceptions, for example when only one supplier can deliver or the cost would be disproportionate (Article 18(5)).
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Check my claimsWhat market it opens for equipment and service suppliers
Article 18 tenders buy medicines, not bioreactors. Article 3 defines a supplier as the manufacturer or marketing authorisation holder of the finished product, or the manufacturer of active substances or key inputs. The Article 18 mechanisms reward where the medicine and its active substance are made, not where the equipment comes from. For equipment suppliers, the opportunity may come from customers investing to manufacture in the EU.
Which medicines are covered matters too. The EMA says the current Union list of critical medicines holds more than 200 active substances. A CDMO or a maker of reagents or primary packaging can fall within the Article 3 definition of supplier. Check whether your customers make anything on the list.
Can a bioprocess equipment maker have a strategic project?
The text does not say so explicitly. Article 5 covers EU projects that create, expand or modernise manufacturing capacity, and point d includes projects that help roll out a technology key to manufacturing critical medicines. Whether a specific project qualifies is decided by the designated authority in each member state (Article 6).
Claims that do not hold up and what to say instead
The biggest risk is treating the act as a seal of approval. It does not approve equipment or certify suppliers, and it is not law yet. One overstated claim makes quality and purchasing teams doubt the rest of your website, and the table suggests wording you can defend.
For a CDMO, Article 18 gives a useful hint. Where proof of EU manufacturing is required, it must come with documents the buyer can verify independently. Explaining which steps happen in the EU, in the same terms as the text, does more than any slogan in a CDMO's B2B marketing.
| Claim to avoid | Why it does not hold up | What you can say |
|---|---|---|
| Equipment approved under the Critical Medicines Act | The act does not approve equipment or suppliers | Equipment for plants expanding or upgrading capacity in the EU |
| The new law already requires buying European | In November 2026 there is a provisional agreement, not yet published in the Official Journal | Under the text agreed in May 2026, public procurement will have to favour EU manufacturing where dependence on non-EU countries is high |
| Our equipment will earn you points in tenders | Points go to the medicine manufacturer based on where it manufactures | Where we manufacture and where we provide service from, with facts the customer can check |
| Guaranteed access to funding for strategic projects | Member states may prioritise support and the designated authority decides | Technical documentation the customer can use in its application |
| CMA compliant | Obligations fall mainly on member states, public buyers and funding beneficiaries | A summary of the act with dates and links to official sources |
Does the act affect how pharma companies buy equipment?
Not directly. The public procurement rules in Article 18 apply to public buyers of critical medicines. Any effect on equipment may come later, if pharma companies decide to manufacture more in the EU to win those tenders or to use the benefits of strategic projects.
How to cover it on your website, at trade shows and in meetings
On your website, a short page about the act works better than a line on the home page. It should say where the act stands, what the articles relevant to your customers say and what you bring, with a date and a link to the Council, the Commission or Parliament.
At trade shows and customer meetings, lead with the customer's project. Ask whether they have a site that could qualify as a strategic project or whether they sell medicines on the list. Prepare data on capacity, efficiency or innovative processes without saying the act requires it. If you manufacture in the BioRegion of Catalonia, say where you build your equipment and where you provide service from.
If you sell bioprocess equipment, marketing for biotech and bioprocess companies should start from these details rather than the headline. At crida studio we work on the message for each member of the buying committee and the evidence behind it.
