How to Choose a CDMO in Europe: EU-GMP Licences, QP Release and What to Check (2026)

By the PharmaTradz BD Team. Published October 2026.

People searching for a contract manufacturer in Europe often type the same thing: a CDMO "with an EMA licence". The problem is that no such licence exists. The European Medicines Agency approves medicines, not factories. Manufacturing licences in the EU are issued by national authorities, and the quality of a European partner shows up in a few documents and habits that are easy to check once you know where to look. This guide covers how the European system works, what a reliable CDMO can show you, the extra checks for sterile products and gene therapies, and the regulatory changes that matter for contracts signed in 2026 and 2027.

It is written for sourcing, business development and quality teams. It is not legal or regulatory advice. Confirm the details of any specific project with your regulatory adviser and the authority concerned.

Who actually licenses a European CDMO

Every site in the EU and EEA that makes, tests or releases medicines needs a manufacturing and importation authorisation (MIA). It is issued by the national competent authority of the country where the site sits, for example Germany's regional inspectorates, Italy's AIFA, France's ANSM or Ireland's HPRA. The authority inspects the site against EU Good Manufacturing Practice, set out in EudraLex Volume 4, and issues a GMP certificate after a satisfactory inspection.

The EMA coordinates inspections for centrally authorised products and runs the shared database. It does not hand out manufacturing licences. So when a partner says it is "EMA approved", ask what it means. Usually it means one of three things:

• the site holds an MIA and a current GMP certificate from a national authority;
• the site makes products that have a central EU marketing authorisation; or
• the site has passed an inspection carried out on behalf of the EMA.

All three are useful, but they are not the same thing. The first one is the minimum for any EU manufacturing partner.

Check the paperwork in five minutes: EudraGMDP

The EU's EudraGMDP database is public. Search it by company name or site address and you can see:

• the manufacturing and importation authorisations the site holds, with the dosage forms and activities they cover;
• GMP certificates, with the inspection date and the issuing authority;
• any statements of non-compliance, which are the strongest warning sign in European GMP.

Two things are worth reading closely. First, the scope: an authorisation that covers tablets and capsules does not cover sterile filling, and one that covers secondary packaging does not cover manufacture. Second, the date of the last inspection. A certificate from several years ago is not a red flag on its own, because inspection cycles are risk-based, but you should ask whether the site has been inspected since and by whom. For a wider checklist that also covers suppliers outside Europe, see our guide on how to verify a pharmaceutical supplier.

The Qualified Person: the role that defines European manufacturing

No batch of medicine reaches the EU market until a Qualified Person (QP) named on a manufacturing authorisation has certified it. The QP confirms that the batch was made and tested in line with GMP and with the marketing authorisation. EU GMP Annex 16 sets out how this works in detail.

For a buyer, the QP question shapes the whole supply chain:

• Who will certify your batches? A full-service CDMO usually provides QP release in-house. A smaller site may rely on a contracted QP or on your own QP. Agree this in writing before tech transfer, not afterwards.
• Where is the product imported? Medicines made outside the EU must be imported by an MIA holder, re-tested in the EU and certified by a QP. Some of this re-testing is waived for products made under a mutual recognition agreement (see below).
• Who signs the quality agreement? EU GMP Chapter 7 requires a written contract between the marketing authorisation holder and every outsourced manufacturer and lab. A reliable CDMO will raise this early.

What reliable looks like: eight checks before you sign

1. Authorisation scope that matches your product. Check the MIA lists the exact dosage form and every activity you need: manufacture, packaging, testing, batch release.
2. Inspection history in your target markets. If you will also sell in the US, ask about FDA inspection outcomes. For Japan, Brazil or the Gulf, ask whether those authorities have inspected the site.
3. Experience with your molecule class. High-potency compounds, cytotoxics, hormones and penicillins all need dedicated or carefully segregated facilities. Ask how cross-contamination is controlled and whether health-based exposure limits have been set for shared equipment.
4. Nitrosamine and impurity readiness. European authorities expect a nitrosamine risk assessment for every product. Ask whether the CDMO has done these for similar products and who pays for confirmatory testing.
5. Serialisation capability. Prescription medicines in the EU must carry a unique identifier and anti-tampering device under the Falsified Medicines Directive. Check that the packaging lines can do this for every market you plan to supply.
6. Supply chain for APIs. APIs imported into the EU need a written confirmation from the exporting country's authority unless that country is on the EU's equivalence list. Ask which API sources the CDMO already has qualified.
7. Realistic capacity. European CDMOs are busy, especially for sterile filling and biologics. Ask for the earliest slot for validation batches and commercial supply, and what happens if a larger customer needs the same line. Our CDMO capacity board lists open slots by dosage form and approval.
8. Ownership of data and the dossier. Agree who owns development data, analytical methods and the CTD modules. This matters if you later move production or license the product.

Sterile products: Annex 1 is now the baseline

The revised EU GMP Annex 1 on sterile manufacturing has applied since August 2023. The one remaining transition, for lyophiliser loading, ended in August 2024. It introduced a documented contamination control strategy for every sterile site, stronger expectations for barrier technology (isolators and restricted access barrier systems), and stricter rules on environmental monitoring and filter integrity testing.

When you assess a European sterile CDMO, ask to see a summary of its contamination control strategy, which lines use isolators, and how it handled the Annex 1 gap assessment. Sites that invested early tend to have fewer surprises during audits. Our guides to sterile injectable and lyophilisation contract manufacturing cover the technical questions in more depth.

Gene and cell therapies: a different set of questions

Searches for "the best gene therapy CDMO in Europe" are rising, and Europe has a strong base of viral vector and cell therapy sites. The regulatory picture for these products is different from small molecules:

• Specific GMP rules. Advanced therapy medicinal products (ATMPs) follow a dedicated set of EU GMP guidelines (EudraLex Volume 4, Part IV), built around risk-based approaches for small batches and living starting materials.
• Not covered by most mutual recognition agreements. The EU's agreements with the US, Japan, Canada, Australia, New Zealand and Israel all exclude ATMPs. Only the agreement with Switzerland covers them. Expect each authority to inspect separately if you plan to supply several markets.
• GMO rules. Viral vectors are genetically modified organisms. Clinical trials and manufacturing can require environmental risk assessments that vary between member states.
• Capacity and scale. Ask about vector type (AAV, lentiviral, others), scale (bioreactor volumes), yields, release testing done in-house, and whether the site can support both clinical and commercial supply.

The proposed EU Biotech Act, published by the European Commission at the end of 2025, would shorten clinical trial authorisation timelines and offer extra supplementary protection for biotech medicines and ATMPs with at least one manufacturing step in the EU. It is still a proposal, but it is a reason some developers are choosing European sites for vector and cell manufacturing now. For the commercial side of these therapies, see cell and gene therapy costs.

Mutual recognition agreements: what they save you

The EU has GMP mutual recognition agreements with the United States, Japan, Switzerland, Canada, Australia, New Zealand and Israel. Under these agreements, partner authorities rely on each other's inspections, and for some products the EU import re-testing is waived. The agreement with the US, for example, has removed batch re-testing on import for most human medicines made in the US since July 2019.

The details matter. Each agreement has exclusions, such as vaccines, plasma-derived products, investigational medicines or APIs, depending on the partner. The United Kingdom is not an MRA partner, so UK-made products imported into the EU still need EU re-testing and QP certification. Check the EMA's MRA page for the current scope before you plan a supply route around it.

Regulatory changes to build into 2026–2027 contracts

• The EU pharma package. The overhaul of EU medicines law, which replaces Directive 2001/83/EC and Regulation 726/2004, was politically agreed in December 2025 and is going through its final formal adoption steps in autumn 2026. Publication in the Official Journal comes next, and the new directive must then be written into national law, so most changes will apply from a later date. It includes new expectations on shortage prevention for manufacturers, changes to regulatory data protection, and provisions on decentralised manufacturing and the QP role.
• The Critical Medicines Act. A provisional deal was reached in May 2026. It lets public buyers reward supply chains with more EU-made content for medicines that rely heavily on non-EU sources, and supports "strategic projects" that add EU capacity for critical medicines and their APIs. Publication is expected towards the end of 2026. If you sell into European hospital tenders, the location of your manufacturing may start to affect scoring.
• Digital GMP. Revised drafts of Annex 11 (computerised systems) and Chapter 4 (documentation), and a new Annex 22 on artificial intelligence, went to consultation in 2025. They are not final yet, but they point to tighter expectations on data integrity, audit trails and cybersecurity. Ask prospective partners how they are preparing.

Europe or elsewhere? An honest comparison

European CDMOs usually cost more per batch than sites in Asia, and lead times for popular technologies can be long. Their strengths are clear, though. They are close to EU and Swiss markets, QP release can happen in-house, the inspection record is transparent, and many sites specialise in complex products: sterile and lyophilised injectables, high-potency compounds, biologics and ATMPs. For simple oral solids, many buyers combine a non-EU manufacturing site with an EU importer and QP release. The site still needs EU GMP, and the importer handles certification. Our global CDMO buyer's guide compares the main regions, and our piece on contract manufacturing versus building in-house looks at the cost side.

How PharmaTradz can help

We work with GMP-certified contract manufacturers across Europe and other regions. Tell us the product, dosage form, target markets and timing, and we will shortlist sites whose authorisations and inspection history match what you need. We can also coordinate the first technical calls and audits. Send us a request and we will come back with options, usually within a few working days.

Frequently Asked Questions(FAQs)

Does the EMA license CDMOs in Europe?

No. Manufacturing and importation authorisations and GMP certificates are issued by the national authority of the country where the site is located. The EMA coordinates inspections for centrally authorised medicines and runs the EudraGMDP database, where you can check a site's authorisation and GMP certificates.

How do I check whether a European CDMO is GMP compliant?

Search the site in EudraGMDP. Check that its manufacturing authorisation covers your dosage form and activities, look at the date and issuing authority of its latest GMP certificate, and confirm that there are no statements of non-compliance. Then ask for recent inspection reports from other authorities that matter for your markets.

What does a Qualified Person do?

A Qualified Person certifies that each batch was made and tested in line with EU GMP and the marketing authorisation before it can be released in the EU. Many European CDMOs offer QP release as part of their service. Agree who will certify your batches before tech transfer begins.

Which European CDMOs can manufacture gene therapies?

Look for sites whose authorisation covers advanced therapy medicinal products and that work under the EU GMP guidelines for ATMPs. Check the vector types and scales they handle, their in-house release testing and their experience with both clinical and commercial supply. Most mutual recognition agreements exclude ATMPs, so plan for separate inspections if you will supply outside the EU.

Are European CDMOs more expensive than those in Asia?

Usually, yes, per batch. Buyers often choose Europe for complex products, proximity to EU and Swiss markets, in-house QP release and a transparent inspection record. For simpler products, a non-EU site with EU GMP certification combined with an EU importer can be more cost-effective.

Will the Critical Medicines Act change how European tenders are scored?

It may. The provisional agreement reached in May 2026 allows public buyers to reward supply chains with more EU-made content for critical medicines that depend heavily on non-EU sources. Formal adoption is expected around the end of 2026, so check each tender's criteria as the rules take effect.