ATMPs can be classified into three main types:
In addition, some ATMPs may contain one or more medical devices as an integral part of the medicine, which are referred to as combined ATMPs. An example of this is cells embedded in a biodegradable matrix or scaffold.
Unregulated advanced therapies may put patients at risk causing serious side effects without any proven benefits.
These products are often sold on websites or through social media channels as a last hope, exploiting the worries of patients and their families.
Authorities are clamping down on those supplying unregulated ATMPs and encourage patients and caregivers to report suspicious cases to their national authorities.
To find the full list of EU NCAs, see:
EMA's Committee for Advanced Therapies (CAT) and the Heads of Medicines Agencies (HMA) released a statement on the risks of unregulated advanced therapies.
This statement follows reports of providers offering unregulated dendritic cell therapies for cancer treatments in EU.
The statement also covers practical advice for patients and caregivers on how to identify unregulated advanced therapies.
EMA and HMA published this joint statement in March 2025.
Read the full joint statement
Watch out for the warning signs described below that an advanced therapy may be unregulated and illegally supplied:
EMA's Committee for Advanced Therapies issued a similar statement in April 2020. Find the document below:
All advanced therapy medicines are authorised centrally via the European Medicines Agency (EMA). They benefit from a single evaluation and authorisation procedure.
As with all medicines, EMA continues to monitor the safety and efficacy of advanced therapy medicines after they are approved and marketed.
EMA also gives scientific support to developers to help them design pharmacovigilance and risk management systems used to monitor the safety of these medicines.
In October 2017, the European Commission and EMA published a joint action plan on ATMPs, which aims to streamline procedures and better address the specific requirements of ATMP developers.
It contains several actions for the European Commission and EMA.
In February 2018, as part of the joint action plan, EMA published:
For more information, see:
The action plan takes into account the ideas collected at an EMA-hosted multi-stakeholder workshop to explore solutions to challenges in the development of ATMPs.
Expand the headings for more information on ATMP development guidance.
Academic and non-profit organisations involved in developing promising advanced therapy medicines (ATMPs) could apply for EMA's increased support in meeting regulatory requirements via a pilot launched in September 2022.
The pilot provided dedicated assistance for ATMP developers targeting unmet clinical needs. The assistance included:
The pilot aimed to assess the level of regulatory support needed to boost the number of advanced therapy medicines that reach patients in the EU and European Economic Area (EEA).
Online training modules are available to help ATMP developers navigate the regulatory environment for these types of medicine.
Developers can access these modules for free via the TransMed Academy (login required).
The modules cover the following subjects:
Recorded webinars are also available on Youtube:
EMA has produced these training materials together with EATRIS as part of the ADVANCE EU training project targeting ATMP developers.
The Agency's Committee for Advanced Therapies (CAT) plays a central role in the scientific assessment of advanced therapy medicines. It provides the expertise that is needed to evaluate advanced therapy medicines.
During the assessment procedure, the CAT prepares a draft opinion on the quality, safety and efficacy of the advanced therapy medicine. It sends this to the Committee for Medicinal Products for Human Use (CHMP). Based on the CAT opinion, the CHMP adopts an opinion recommending or not the authorisation of the medicine by the European Commission. The European Commission makes its final decision on the basis of the CHMP opinion.
The CAT also:
Stem cells are naturally occurring cells in the body that have the ability to divide and produce a range of different cell types. Stem cells are important in the growth and development of the body, as well as in repair after injury.
Stems cells are categorised as ATMPs when these cells undergo substantial manipulation or are used for a different essential function. They can be somatic-cell therapy products or tissue-engineered products, depending on how the medicine works in the body.
EMA follows research into the use of stem cells in medicines very closely and is responsible for assessing marketing authorisation applications for medicines containing stem cells.
The Agency has been advising developers of stem cell-based medicines for a number of years:
In February 2011, EMA published a reflection paper on stem cell-based medicinal products. The paper stressed the fact that developers of stem-cell based medicines need to pay close attention to the way the medicines are manufactured, to ensure that the final medicine is as consistent and reproducible as possible. Pre-clinical and clinical testing also needs to take account of the cells' properties, ensuring that the possible risks of tumour development and rejection by the body are studied adequately and balanced against their benefits for patients.
The reflection paper was adopted by the CAT on 14 January 2011. This followed a public consultation between March and June 2010 and discussion at a public workshop in May 2010 involving 230 participants from academia, industry and regulatory authorities.
For more information, see: