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Overview ATMP literature

On this page, you find our growing collection of articles, publications and other information material concerning ATMP (advanced therapy medicinal products) or TEMP (tissue engineered medicinal products) development, tests, validation and use.

Some summary articles (partyl in German) are these:

Hautmodell

EU Directives and Regulations

Here we have listed links to English or German versions of regulations, directives guidelines etc. concerning MP (medicinal products), vMP (veterinary medicinal products), ATMP (advanced therapy medicinal products), blood, EMA (european medicines agency = EMEA), GCP (good clinical practise), Tisuue, GMP (good manufacturing practise), MD (medical devices). Directives are guiding documents that have to be implemented by national laws in the EU member states. Due to these national implementations, national "flavours" in the specifications are possible. It is therefore, always recommended to read national laws and the respective europpean directives to avoid misinterpretation, e.g. when trying to grasp "industrially prepared". Regulations on the other hand are directly binding european "laws" that do not require further national implementation.Further links to authorities and commitees are listed on our authorities links page.

Document keyword Title Comment
REG 1394/2007 ATMP Advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 Link
REG 726/2004 EMA Laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency Link
RL 2006/17/EG Tissue

Implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells

Durchführung der Richtlinie 2004/23/EG des Europäischen Parlaments und des Rates hinsichtlich technischer Vorschriften für die Spende, Beschaffung und Testung von menschlichen Geweben und Zellen = Erweiterung Geweberichtlinie

Link

Quelle

RL 2006/86/EG Tissue

Implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells

Umsetzung der Richtlinie 2004/23/EG des Europäischen Parlaments und des Rates hinsichtlich der Anforderungen an die Rückverfolgbarkeit, der Meldung schwerwiegender Zwischenfälle und unerwünschter Reaktionen sowie bestimmter technischer Anforderungen an die Kodierung, Verarbeitung, Konservierung, Lagerung und Verteilung von menschlichen Geweben und Zellen

Link

Quelle

RL 2005/28/EG GCP

Laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products

Festlegung von Grundsätzen und ausführlichen Leitlinien der guten klinischen Praxis für zur Anwendung beim Menschen bestimmte Prüfpräparate sowie von Anforderungen für die Erteilung einer Genehmigung zur Herstellung oder Einfuhr solcher Produkte

Link

Quelle

RL 2004/23/EG  Tissue

Setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

Festlegung von Qualitäts- und Sicherheitsstandards für die Spende, Beschaffung, Testung, Verarbeitung, Konservierung, Lagerung und Verteilung von menschlichen Geweben und Zellen = Geweberichtlinie

Link

Quelle

RL 2004/27/EC MP Amending Directive 2001/83/EC on the Community code relating to medicinal products for human use Link
RL 2003/94/EG GMP

Laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use

Festlegung der Grundsätze und Leitlinien der Guten Herstellungspraxis für Humanarzneimittel und für zur Anwendung beim Menschen bestimmte Prüfpräparate

Link

Quelle

RL 2002/98/EG Blood

Setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC

Festlegung von Qualitäts- und Sicherheitsstandards für die Gewinnung, Testung, Verarbeitung, Lagerung und Verteilung von menschlichem Blut und Blutbestandteilen und zur Änderung der Richtlinie 2001/83/EG

Link

Quelle

RL 2001/20/EG GCP

On the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use

Angleichung der Rechts- und Verwaltungsvorschriften der Mitgliedstaaten über die Anwendung der guten klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Humanarzneimitteln 

Link

Quelle

RL 2001/82/EG vMP

On the Community code relating to veterinary medicinal products

Schaffung eines Gemeinschaftskodexes für Tierarzneimittel

Link

Quelle

RL 2001/83/EG MP

On the Community code relating to medicinal products for human use

Schaffung eines Gemeinschaftskodexes für Humanarzneimittel

Link

Quelle

RL 95/46/EG Data

On the protection of individuals with regard to the processing of personal data and on the free movement of such data

Schutz natürlicher Personen bei der Verarbeitung personenbezogener Daten und zum freien Datenverkehr = Datenschutzrichtlinie

Link

Quelle

RL 93/42/EWG MD

Medical devices

Medizinprodukte

Link

Quelle

RL 90/385/EWG MD

On the approximation of the laws of the Member States relating to active implantable medical devices

Angleichung der Rechtsvorschriften der Mitgliedstaaten über aktive implantierbare medizinische Geräte 

Link

Quelle

 

FDA, EMA und CAT: Guidelines (GL, GD), Reflection Papers (RP) und Position paper (PP)

 Document Inst. Year  Title  Comment
GD draft FDA 2015
Homologous Use of Human Cells,Tissues, and Cellular and Tissue-Based Products
pdf
GD draft FDA 2014
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue:Regulatory Considerations
pdf
GD FDA 2014
Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
pdf
GL EMA 2013 Guideline on the risk -based approach according to annex I, part IV of Directive 2001/83/EC applied to Advanced therapy medicinal products Source
GD FDA 2012 Pyrogen and Endotoxins Testing: Questions and Answers Source
GL EMA 2011 Guideline on analytical method validation Source
GD FDA 2011 Potency Tests for Cellular and Gene Therapy Products Source
GD FDA 2011
Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
pdf
GL EMA 2009 Guideline on xenogeneic cell-based medicinal products Source
GL EMA 2009 Detailed guidelines on good clinical practice specific to advanced therapy medicinal products Source
GL EMA 2008 Guideline on safety and efficiacy follow-up-risk manegement of advanced therapy medicinal products Source
GD FDA 2008 Draft: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products  Source
GL EMA 2007 Guideline on cell-based immunotherapy medicinal products for the treatment of cancer Source
GL EMA 2006 Guideline on human cell-based medicinal products Source
GL EMA 2006 Guideline on virus safety evaluation of biotechnological investigational medicinal products Source
nG EMA 2003 Note for guidance on the use of bovine serum in the manufacture of human biological medicinal products Source
RP ? EMA 2017 Development of non-substantially manipulated cell-based ATMPs1: flexibility introduced via the application of the risk-based approach pdf
RP EMA 2014 Reflection paper on classification of advanced therapy medicinal products  Source
RP EMA 2013 Reflection paper on management of clinical risks deriving from insertional mutagenesis Source
RP EMA 2012 Reflection paper on clinical aspects related to tissue-engineered products Source
RP EMA 2012 Reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products   Source
RP EMA 2011 Reflection paper on stem cell-based medicinal products Source
RP EMA 2010 Reflection paper on in-vitro cultured chondrocyte containing products for cartilage repair of the knee Source
sGL EMA 1997 Replacement of animal studies by in vitro models Source
PS EMA 2011 Position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products Source

 

Hygiene monitoring in ATMP production Labs

The monitoring of hygiene or particle load in ATMP (advanced therapeutic medicinal products) producing labs is ofter underestimated. Contamination is a critical factor in such labs as shown in the following publications:

Environmental monitoring in stem cell banks.

Cobo F, Stacey GN, Cortés JL, Concha A.: Appl Microbiol Biotechnol 2006 May;70(6):651-62. Review

Review: production, characterization, and testing of banked mammalian cell substrates used to produce biological products.

Schiff LJ: In Vitro Cell Dev Biol Anim. 2005 Mar-Apr;41(3-4):65-70. Review

Microbiological risk assessment in stem cell manipulation.

Pessina A, Bonomi A, Baglio C, Cavicchini L, Sisto F, Neri MG, Gribaldo L.: Crit Rev Microbiol 2008;34(1):1-12. Review

Medical biofilms.

Bryers JD.: Biotechnol Bioeng 2008 May 1;100(1):1-18. Review

 

ATMP in clinical trials

ATMPs and TEMPs carry a huge potential for modern medicine. More and more clinical trials are started now.

A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation.

García-Olmo D, García-Arranz M, Herreros D, Pascual I, Peiro C, Rodríguez-Montes JA.: Dis Colon Rectum 2005 Jul;48(7):1416-23.

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