Clinics and manufacturers for ATMPs and tissue preparations
in Germany, EU, USA, Canada, Japan, Switzerland

To date, there is no official PEI or FDA page that makes manufacturers of ATMPs with GMP/GFP authorizations easy to find. InCelligence therefore lists clinics, medical institutions, and companies here, ordered according to the principle of patient safety, GMP/GFP/SOHO status, and regulatory authority controls. Germany / the EU regulate more strictly than the USA, etc. Listings on this page are not subject to payment.

As of: 17.09.2026. This overview does not include clinical trials, as these can be easily found at https://clinicaltrials.gov/ The regulatory status refers to publicly verifiable approvals, authorizations, manufacturing authorizations, and certificates. Evidence that cannot be found publicly does not automatically mean that a treatment is illegal. The overview is continuously expanded; despite systematic research, completeness cannot be guaranteed.

The InCelligence listing order and its criteria

The order is based on InCelligence criteria according to the degree of regulatory assurance and regulatory authority control. It is assumed that additional regulatory controls can increase the level of safety. Efficacy is deliberately excluded from the ranking, as Safety and Efficacy are two separate areas and can result in different rankings. The ranking is based on safety categories from GMP regulations and logical deductions derived from them. 

• Level 1: approved medicinal products = highest level of regulatory assurance according to InCelligence criteria (approved medicines, marketing authorization)
  • The longer the medicinal product has been approved, the more long-term experience may be available, as long-term adverse effects may only be recognized late after approval 
• Level 2: additional product-specific regulatory authorization as well as GMP status for ATMPs/TEPs and regulated GFP status for tissue preparations
  • Section 4b AMG authorization by the Paul-Ehrlich-Institut for ATMPs as an additional level of regulatory control for supply to others under the Hospital Exemption
  • Section 21a AMG authorization by the Paul-Ehrlich-Institut for tissue preparations as an additional product-specific level of regulatory control
  • procurement and manufacturing authorization under Sections 20b and 13 AMG for ATMPs in Germany, analogous in other countries 
  • procurement as well as processing and handling authorization under Sections 20b and 20c AMG for tissue preparations in Germany, analogous in other countries 
• Level 3: GMP status for ATMPs/TEPs and regulated GFP status for tissue preparations without additional product-specific Section 4b or Section 21a authorization
  • No Section 4b AMG authorization is necessary if the ATMP is not supplied to others
  • procurement and manufacturing authorization under Sections 20b and 13 AMG for ATMPs in Germany, analogous in other countries 
  • procurement as well as processing and handling authorization under Sections 20b and 20c AMG for tissue preparations in Germany, analogous in other countries 
• Level 4: Providers with significant regulatory warning signs or contradictory regulatory information, without illegality being inferred from this alone
• Level 5: no comprehensible regulatory status, no publicly verifiable certificates or authorizations, potentially illegal

The search for clinic or company names as well as diseases or areas of application can be performed using Ctrl+F: then enter the search term.

Germany: Regularly approved ATMPs and tissue preparations

Level 1: According to the InCelligence criteria, this category has the highest level of regulatory assurance. In addition to controlled manufacturing, a regular medicinal product approval includes a regulatory assessment of the specific medicinal product, including quality, safety, and efficacy, as well as ongoing monitoring after approval. The classification describes the level of regulatory assurance and not the efficacy for an individual patient.

D: ATMPs and tissue preparations with additional product-specific authorization under Section 4b or Section 21a AMG

Level 2: In addition to authority-controlled manufacturing or processing, the specific product has a further authorization from the Paul-Ehrlich-Institut. For ATMPs, this is in particular the authorization under Section 4b AMG for supply to others under the Hospital Exemption; for tissue preparations, the authorization under Section 21a AMG is the additional product-specific level of control. This additional regulatory review is the basis for classification above manufacturing controlled exclusively under GMP/GFP.

D: Authority-controlled manufacturing of ATMPs / tissue preparations under GMP or GFP without additional Section 4b or Section 21a authorization

Level 3: Manufacturing or processing and handling is subject to regulatory authorization, inspections, and regulated quality management under GMP or GFP. An additional product-specific authorization under Section 4b AMG is not required for an ATMP if it is not supplied to others. The level of regulatory assurance is classified below Level 2 because there is no additional product-specific PEI authorization for supply to others.

Germany: Unclear regulatory status – potentially illegal

Stufe 5: This is the lowest level of publicly traceable regulatory assurance. The providers describe cell, stem cell, SVF, or comparable treatments, while a relevant approval, authorization, manufacturing authorization, or GMP/GFP evidence could not be clearly identified publicly. Missing public evidence does not automatically mean that a treatment is illegal; “potentially illegal” refers exclusively to the possibility that a required regulatory basis is missing.

EU: Centrally approved ATMPs – rest of the European Union

Level 1: ATMPs in the EU are generally approved centrally through the EMA and European Commission. The approval is valid throughout the EU. This table lists current approvals; withdrawn or expired approvals such as Alofisel are not included.

USA: FDA-approved cell, stem cell, and tissue products

Tier 1: This category corresponds to the highest level of regulatory assurance according to InCelligence criteria. The products have FDA approval or a Biological License Application (BLA) under Section 351 of the Public Health Service Act. The FDA evaluates the specific product, including manufacturing, quality, safety, and efficacy. Clinical trials and IND-only applications are not listed in this overview.

US: FDA-registered HCT/P tissue establishments without a product-specific BLA

Tier 3: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) in the USA may be regulated solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271 if, in particular, the requirements for minimal manipulation and homologous use are met. The establishments must be registered with the FDA and are subject to Current Good Tissue Practice (CGTP). In the US HCT/P system, FDA registration of an establishment or listing of a product expressly constitutes neither regulatory approval nor confirmation of regulatory compliance: FDA registration merely means that the establishment or HCT/P is recorded in the registration system; it does not include prior review or approval of the product by the FDA and also does not confirm that the regulatory requirements are actually met. These establishments are not subject to FDA oversight, unlike German institutions that have a GMP / GFP authorization.

US: Providers with significant regulatory warning signs officially documented by authorities

Tier 4: In this category, there is not merely missing information, but specific regulatory objections by the FDA. The classification refers exclusively to the products and circumstances named in the respective FDA Warning Letters. It is not an assessment of the entire establishment beyond this.

Canada: Approved cell, stem cell, and gene therapy products

Tier 1: These products have medicinal product approval from Health Canada in the form of a Notice of Compliance (NOC) or Notice of Compliance with Conditions (NOC/c). This approval must be clearly distinguished from the mere registration of a cell or tissue establishment.

CA: Registered cell, tissue, and organ establishments without product-specific medicinal product approval

Tier 3: Establishments that process, distribute, or import cells, tissues, or organs under the Canadian CTO Regulations may be registered with Health Canada. This registration documents the regulatory registration of the establishment and the application of the CTO safety requirements, but does not constitute approval of a specific cell or tissue product as a medicinal product. These establishments are not subject to regulatory authority oversight, unlike German establishments with GMP / GFP authorizations.

Japan: Approved regenerative medical products

Tier 1: Japan has its own medicinal product category for regenerative medical products. The products are evaluated by PMDA and approved by the Ministry of Health, Labour and Welfare. In addition to regular approvals, time-limited or conditional approvals exist; these are identified as such.

JP: Regenerative treatments under the Act on the Safety of Regenerative Medicine without product approval

Tier 3: Japan permits certain regenerative treatments outside regular product approval under the Act on the Safety of Regenerative Medicine. Medical institutions must submit a Regenerative Medicine Provision Plan for this purpose; different levels of review and oversight apply depending on the risk class. Government registration or notification of a treatment plan is not approval of the cell product used.

CH: ATMPs and transplant products approved by Swissmedic

Tier 1: Standardized transplant products, somatic cell therapies, tissue-engineered products, and gene therapies are subject to approval by Swissmedic in Switzerland. Substantially manipulated cells – for example after cell culture or expansion – are generally assigned to the category of transplant products/ATMPs.

Disclaimer and transparency

Dr. Nicole Kühl is a cell culture, ATMP, and GMP consultant. She advises companies on cell culture, ATMPs, GMP, and quality management, among other areas, supports the development and optimization of bioassays, and provides specialist courses in these areas. Dr. Nicole Kühl has worked for several of the companies listed on this page or continues to provide consulting services to them. These business relationships have no influence on whether a company is included in this overview or how its regulatory status is classified according to the InCelligence criteria described here.

All information on this page is based exclusively on publicly available information, in particular information from regulatory authorities, public registers, approval and authorization data, and publicly available information from the respective establishments and companies. Despite careful research, no guarantee can be given for the completeness, timeliness, and accuracy of all information. To the extent permitted by law, Dr. Nicole Kühl cannot accept responsibility for incorrect classifications resulting from incomplete, outdated, or inaccurate publicly available information.

Further information

• ATMP and TEMP
• Cell culture under GMP
• Bioassays / cell-based assays
• Consulting on cell culture, GMP, ATMPs, tissue preparations, and bioassays
• About InCelligence and Dr. Nicole Kühl

Author: Dr. Nicole Kühl | Reviewed by: Dr. Nicole Kühl | Last updated: 17.09.2026