Advanced cell therapy medicinal products with cultured mesenchymal cells (CMC) occupy a unique space in contemporary medicine today. They combine cell biology, pharmaceutical manufacturing, and individualized clinical application, which is why they require a strict supervisory framework.
In Spain, this framework is administered by the Spanish Agency of Medicines and Medical Devices (AEMPS). Understanding the role this agency plays, what exactly it oversees, and the guarantees that arise from its intervention enables both the patient and the healthcare professional to critically assess the difference between a regulated treatment and a procedure that is not regulated.
The AEMPS: Spain’s regulatory authority for medicinal products
The AEMPS is the public agency, attached to the Ministry of Health, responsible for guaranteeing the quality, safety, efficacy, and accurate information of medicinal products and medical devices in Spain. Its activity operates within the European Medicines System, coordinated with the European Medicines Agency (EMA), with which it maintains a direct working relationship in the evaluation of advanced therapy medicinal products.
The AEMPS authorizes clinical trials, inspects manufacturing facilities, evaluates the pharmaceutical quality of medicinal products, oversees their clinical application, monitors potential adverse reactions (pharmacovigilance), and issues specific resolutions concerning advanced therapy medicinal products. In short, it is the authority that guarantees whether and under what conditions a medicinal product can be administered in Spain.
Why an advanced cell therapy medicinal product requires specific supervision
An advanced cell therapy medicinal product with CMC is not comparable to a conventional drug. It is produced from cells obtained from the patient or from a donor, which are isolated, selected, and cultured in the laboratory over several weeks until a therapeutic dose is obtained. Each batch of the medicinal product is the result of a living biological process, not of industrial chemical synthesis. This singularity explains why the European regulatory framework, Regulation (EC) 1394/2007 on advanced therapy medicinal products, and Spanish legislation require a particularly demanding level of control.
AEMPS supervision covers the full lifecycle: from the clinical research that demonstrates the medicinal product’s value, through its manufacturing under pharmaceutical standards, its administration to the patient, and the subsequent follow-up. This is not an isolated administrative procedure but a continuous chain of evaluation that accompanies the medicinal product at every stage.
The dimensions of AEMPS supervision
The intervention of the AEMPS in an advanced cell therapy medicinal product is organized along four complementary dimensions. Each one provides a specific layer of guarantee for the patient:
1. Authorization of clinical trials
Every advanced therapy medicinal product must be studied in authorized clinical trials before it can be administered in a structured manner. The AEMPS evaluates the trial design, the inclusion criteria, the safety measures, and the suitability of the product, and oversees its development. Without an express authorization from the agency, the trial cannot begin. This initial level of supervision is what makes it possible to generate the scientific evidence that supports the use of the medicinal product.
2. Manufacturing in a cleanroom under GMP standards
The medicinal product is manufactured exclusively in an authorized facility that complies with Good Manufacturing Practice (GMP) standards. The AEMPS inspects these facilities, validates the production processes, and verifies that traceability, quality controls, and cellular characterization meet pharmaceutical standards. GMP cleanroom manufacturing is one of the most important differentiating elements of advanced cell therapy medicinal products compared to other procedures that administer cells without this level of control.
3. Clinical application with AEMPS authorization
The administration of an advanced cell therapy medicinal product with CMC requires the corresponding AEMPS authorization. Each treatment is evaluated on a case-by-case basis, and each batch of the medicinal product is subject to specific controls before release. This intervention ensures that the medicinal product reaches the patient with all regulatory requirements verified.
See also: Which cell therapies can be considered legal and regenerative?
4. Pharmacovigilance and post-treatment follow-up
AEMPS supervision does not end with administration. Advanced therapy medicinal products are subject to pharmacovigilance obligations: any adverse reaction must be documented and reported, and the agency retains access to the clinical information needed to assess the medicinal product’s safety over time. Structured clinical follow-up of the patient (including evaluation by magnetic resonance imaging, when applicable) is an integral part of this framework.
What AEMPS supervision guarantees to the patient
AEMPS intervention provides the patient with a series of concrete guarantees that are worth making explicit:
- It guarantees that the medicinal product has been evaluated by an independent health authority, not only by the medical team prescribing it. A second regulatory instance validates the appropriateness of the treatment.
- It guarantees that the medicinal product has been manufactured under pharmaceutical standards, in an inspected facility, with documented quality controls and full traceability. It is not an improvised product, nor one prepared outside the quality standards required of any medicinal product.
- It guarantees a clearly defined chain of responsibility: the prescribing physician, the manufacturing facility, the administering center, and the regulatory authority. That chain is, in itself, a structural guarantee.
- It guarantees active health surveillance. Should any issues arise, the authorities have the information and the mechanisms required to act.
How to distinguish a medicinal product authorized by the AEMPS from unregulated procedures
In today’s healthcare landscape, alongside advanced cell therapy medicinal products supervised by the AEMPS, there exist a number of procedures that are communicated to the public using similar terminology but that do not meet the same regulatory requirements. Offerings such as “stem cell treatments,” “regenerative medicine,” or “biological therapies” are frequently encountered, applying uncultured cell concentrates, same-day cellular fractions, or platelet-rich plasma presented as an equivalent treatment.
These procedures, insofar as they do not involve cell culture or substantial manipulation under the European framework for advanced therapy medicinal products, are not classified as medicinal products and are not subject to AEMPS oversight. They are not manufactured in a GMP cleanroom, are not cellularly characterized according to pharmaceutical standards, and do not require the same level of traceability or surveillance.
From the patient’s perspective, the issue is not about labels. It is about guarantees. An advanced cell therapy medicinal product with CMC supervised by the AEMPS and an unregulated procedure may appear superficially similar in commercial messaging, but they are distinct regulatory, scientific, and clinical realities.
How to verify a center’s regulatory framework
The patient can request from the center explicit information about the applicable regulatory framework, the GMP manufacturing facility it works with, and the authorized clinical trials that support its clinical activity.
The AEMPS publishes public information on authorized clinical trials and on advanced therapy medicinal products through its electronic portal, accessible to any citizen. This transparency is one of the defining features of the European medicines framework.
The ITRT approach: more than two decades working under AEMPS supervision
At ITRT, we develop exclusively advanced cell therapy medicinal products with cultured mesenchymal cells (CMC), manufactured in a GMP cleanroom and administered under the corresponding AEMPS authorization.
We have operated at the Centro Médico Teknon in Barcelona for more than twenty years, during which time we have sponsored multiple clinical trials authorized by the AEMPS in indications such as joint osteoarthritis, chronic tendinopathy, lumbar degenerative disc disease, non-union fractures, osteonecrosis, and xerostomia.
Our clinical activity is led by Dr. Robert Soler, Medical Director, and is supported by an exclusive process for the procurement, culture, and administration of CMC, as well as a structured clinical and imaging follow-up program.
We have published the results of several of these indications in international peer-reviewed scientific journals, including studies with long-term follow-up and magnetic resonance imaging evaluation.
This combination of clinical evidence, regulatory framework, and track record is what defines our institutional approach. For us, AEMPS supervision is not a formal requirement but the structural framework within which all our activity is carried out: a quality guarantee for the patient, an evidence base for the scientific community, and an institutional reference for the sector as a whole.
Frequently asked questions
What exactly does the AEMPS oversee in an advanced cell therapy medicinal product?
The AEMPS supervises the medicinal product’s full lifecycle: authorization of clinical trials, inspection of GMP manufacturing facilities, the medicinal product’s quality and traceability, its clinical application, and subsequent pharmacovigilance.
What is GMP manufacturing and why does it matter?
Good Manufacturing Practice (GMP) standards are the international pharmaceutical standards that regulate the production of medicinal products. They ensure that the medicinal product is manufactured in authorized facilities, with validated processes, documented quality controls, full traceability, and objective cellular characterization.
Are all cell-based procedures supervised by the AEMPS?
No. Only those that meet the criteria to be classified as advanced therapy medicinal products under the European framework. Procedures that administer cells without culture or substantial manipulation are not classified as medicinal products and are not subject to the same regulatory oversight.
How can I verify that a center operates under AEMPS supervision?
You can request explicit information from the center about the GMP manufacturing facility it works with and the authorized clinical trials that support its activity. The AEMPS also publishes public information through its electronic portal.
What is the difference between a medicinal product authorized by the AEMPS and a "stem cell" treatment?
The difference is regulatory, scientific, and clinical. An advanced cell therapy medicinal product with CMC is manufactured under GMP standards, cellularly characterized, supported by authorized clinical trials, and administered with AEMPS authorization. Procedures that apply uncultured cell concentrates outside this framework do not meet these conditions.
Legal disclaimer
Advanced therapy medicinal products with cultured mesenchymal cells (CMC) require a medical prescription and individual authorization by the AEMPS. This content is for informational purposes only and does not substitute medical advice. The clinical results mentioned correspond to patients treated in the context of authorized clinical trials and are not extrapolatable to other patients.
