Regulatory Compliance
Approval of ATMPs and biologics.
The authorization of Advanced Therapy Medicinal Products (ATMPs) and biologics requires highly specialized regulatory roadmaps for the EMA’s Committee for Advanced Therapies (CAT)—from the initial classification as a gene, cell, or tissue therapy through to the final centralized procedure. We support biotech companies and clinics from research through to clinical practice.
What specific regulatory requirements apply to ATMPs?
Cell and gene therapies are subject to the strictest regulatory requirements in the entire pharmaceutical industry. Standard approval processes do not apply here:
- Strict ATMP Regulation. The ATMP Regulation (EC) No. 1394/2007 defines specific requirements for gene therapies, somatic cell therapies, and tissue-engineered products that go far beyond those of conventional pharmaceutical dossiers.
- Centralized Procedure. A centralized authorization procedure through the European Medicines Agency (EMA CAT) is mandatory for most ATMPs.
- Specific GMP requirements. The GMP requirements for the manufacture of cell and gene therapies differ fundamentally and require a strict interpretation of the EU GMP guidelines (Annex 2).
- National exemptions. The "Hospital Exemption" (Section 4b of the German Medicines Act) provides an exemption for non-routine ATMPs at hospitals, but is applied very restrictively by the Paul Ehrlich Institute and other national authorities.
We serve as a bridge between academic research and the EMA’s stringent requirements—for highly innovative ATMPs.
Our ATMP and biologics services.
We guide you through the regulatory process for your advanced therapies, from classification to approval.
Regulatory Classification (CAT)
We handle the application process with the EMA Committee for Advanced Therapies (CAT) for official classification as an ATMP and clarify borderline cases (medicinal product vs. ATMP vs. medical device).
Regulatory Strategy & Scientific Advice
Development of a customized regulatory roadmap for the EMA authorization process. We prepare for scientific advice meetings with the EMA (CAT) and provide scientific support throughout the process.
CMC Strategy for ATMPs (Annex 2)
Support for complex CMC development: stability strategies, active ingredient characterization, and the establishment of GMP-compliant manufacturing processes specifically for biologics and ATMPs.
Hospital Exemption & Academic ATMPs
Specialized consulting for university hospitals on the use of the hospital exemption (Section 4b of the German Medicines Act). Assistance with national approval (PEI) and the implementation of a quality management system.
Frequently Asked Questions About ATMPs and Biologics.
What exactly is an ATMP?
Advanced Therapy Medicinal Products (ATMPs) are novel therapies for human use. These include gene therapies, somatic cell therapies, and biotechnologically engineered tissue products (tissue engineering). They are subject to the specific ATMP Regulation (EC) No. 1394/2007.
Which agency is responsible for ATMP approvals?
In Europe, the European Medicines Agency (EMA) is responsible for the Centralized Procedure. The Committee for Advanced Therapies (CAT) conducts the scientific evaluation. However, national authorities (in Germany: the Paul Ehrlich Institute, PEI) are responsible for hospital exemptions.
What is the "Hospital Exemption"?
It allows for the non-routine manufacture and use of an ATMP in a hospital for individual patients under the supervision of a physician, without the need for full EMA authorization. The national requirements for this are extremely strict and often difficult to scale.
How does GMP for ATMPs differ from standard pharmaceuticals?
ATMP-GMP is highly specific (regulated in GMP Annex 2). Key characteristics often include: strictly autologous production (batch size = 1 patient), extremely short shelf lives (sometimes hours rather than years), strictly sterile processes without final sterilization, and complete traceability from the human starting material to the infusion.
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