Since the EU Clinical Trials Regulation, there is a single front door for trial applications across the EU — and behind it, in Germany, two separate approvals that must both be obtained. For a sponsor outside the EU there is also a requirement that catches people late: you cannot be your own sponsor of record without a representative here.
Clinical trials in the EU run under Regulation (EU) 536/2014 (the CTR), in force since 31 January 2022, with CTIS as the single submission portal for the EU and EEA. In Germany a trial needs two green lights: authorisation from the competent federal higher authority — BfArM for most investigational medicinal products, Paul-Ehrlich-Institut (PEI) for vaccines and biomedicines — and a favourable opinion from the competent Ethics Committee. If your company is not established in the EU, Article 74 CTR requires you to appoint an EU legal representative. And a successful trial produces evidence, not market access.
Most of what we write about — authorization, reimbursement, distribution — happens after there is evidence. This is where the evidence is made, under German rules.
The Clinical Trials Regulation replaced a patchwork of national submissions with one harmonised procedure and one portal. That is a genuine simplification: one dossier, one assessment, one decision per member state, all visible in CTIS. Trials still running under the old Directive had to be transferred into CTIS by the end of the transitional period on 31 January 2025 — the old world is closed.
What the CTR did not do is merge Germany's two decision-makers into one. The regulator assesses the science and the product; the ethics committee assesses the protection of the participants. Both must say yes, and a delay in either is a delay to the trial.
One portal is not one approval. In Germany the door has two locks, and you need both keys.
You file once, through CTIS. Inside Germany the application is then assessed on two tracks that run in parallel and must both conclude favourably.
BfArM or the Paul-Ehrlich-Institut, depending on the product. Assesses the investigational medicinal product, the science and the safety data. Grants the trial authorisation.
The competent Ethics Committee gives a favourable opinion on participant protection, consent, investigator suitability and sites. Required in addition to the authority's authorisation.
Germany splits competence by product type. Getting this right at the planning stage avoids an avoidable stumble at submission.
| Authority | Competence | Typical products |
|---|---|---|
| BfArM Federal Institute for Drugs and Medical Devices | Competent authority for clinical trials of investigational medicinal products in Germany, other than those assigned to PEI. | Most small molecules and conventional medicinal products. |
| PEI Paul-Ehrlich-Institut | Carries out the assessment for vaccines and biomedicines. | Vaccines, blood and blood products, biologicals and advanced therapies. |
The same split follows the product later into marketing authorisation and into ongoing safety obligations — see pharmacovigilance & GxP for the duties that begin once a product is on the market.
Where the sponsor of a clinical trial is not established in the Union, the sponsor must ensure that a natural or legal person is established in the Union as its legal representative. That representative is responsible for ensuring compliance with the sponsor's obligations under the Regulation, and is the addressee for all communications with the sponsor.
Two practical points that are widely misunderstood. First, the representative may be established in any EU/EEA member state — it does not have to sit in the country where the trial runs. Second, this is not a postbox function: the role carries real regulatory responsibility and is how member states can take enforcement action and bring proceedings. Choose it as deliberately as you would choose an authorised representative for a device — the logic is the same one we set out in local representation.
For a defect-free, validated application in a mononational German trial, the regulation's clock is genuinely fast — if your dossier does not trigger questions.
Assessment of a validated application for a mononational trial at BfArM.
Final trial authorisation where no deficiencies are raised.
The working group of German medical ethics committees (AKEK) agreed to follow the same timelines.
The number that actually decides your calendar is not on this list: it is how long you take to answer a request for information. The clock stops for deficiencies. A dossier prepared to the German assessors' expectations is worth more than an optimistic Gantt chart.
Looking ahead: in November 2025 European regulators and ethics committees agreed to pilot FAST-EU, a fast-track approach for authorising multinational trials, launching in January 2026. Worth watching if your programme spans several member states.
The CTR procedure is not always the only permission a German trial needs. The most commonly missed one is radiological.
The clock you miss is rarely the one you were watching.
This is the part that decides whether the investment pays back, and it is the reason we treat trials as the first step of an access strategy rather than a scientific project with a separate owner.
A completed German trial gives you evidence generated under EU standards, German investigators and sites, and credibility with local clinicians. What it does not give you is permission to sell or a price. After the trial come marketing authorisation, then — for a new medicine — the benefit assessment and price negotiation that actually set your German revenue.
Which is why the comparator you choose, the endpoints you power for and the population you study should be selected with the later AMNOG benefit assessment in mind, not only the regulator. Evidence designed only to satisfy an approval frequently fails to demonstrate added benefit against the appropriate comparator — and that is an expensive discovery to make years later.
Design the trial for the payer as well as the regulator. One of them approves you; the other one pays you.
We help non-EU and international sponsors set up German trials properly — the right authority, the legal-representative question, a dossier built for German assessors, and an evidence plan that still stands up when the benefit assessment arrives.