Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?

2017 ◽  
Vol 28 (3) ◽  
pp. 126-135 ◽  
Author(s):  
Tomáš Boráň ◽  
Margarida Menezes-Ferreira ◽  
Ilona Reischl ◽  
Patrick Celis ◽  
Nicolas Ferry ◽  
...  
Keyword(s):  
European Union ◽  
Clinical Development ◽  
Regulatory Framework ◽  
The European Union ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Advanced Therapy ◽  
Product Pipeline

scholarly journals Decision-making on marketing authorization of Advanced Therapy Medicinal Products in the European Union

Cytotherapy ◽  
2017 ◽  
Vol 19 (5) ◽  
pp. S85
Author(s):  
S. de Wilde ◽  
D. Coppens ◽  
M.L. de Bruin ◽  
H.G. Leufkens ◽  
H. Guchelaar ◽  
...  
Keyword(s):  
Decision Making ◽  
European Union ◽  
Marketing Authorization ◽  
The European Union ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Advanced Therapy

Current Regulation of Advanced Therapy Medicinal Products in the European Union

2007 ◽  
Vol 4 (1) ◽  
Author(s):  
Heide Muckenfuss ◽  
Klaus Cichutek ◽  
Egbert Flory
Keyword(s):  
European Union ◽  
Medical Practice ◽  
The Other ◽  
The European Union ◽  
Medicinal Products ◽  
Current Regulation ◽  
Safety Aspects ◽  
Advanced Therapy ◽  
Timely Access

AbstractThe rapid biotechnological progress has promoted the development of novel medicinal therapies which are currently changing medical practice substantially. Patients may benefit from new opportunities for the treatment of various diseases, but on the other hand new risks have to be faced. To ensure timely access of patients to innovative medicines while taking safety aspects into consideration, an appropriate legislation is needed. This review aims at giving an overview of the role of the so called “Advanced Therapy Products” in today's medical practice and describes their current regulation in the European Union (EU).

scholarly journals Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 347
Author(s):  
Marina López-Paniagua ◽  
Ana de la Mata ◽  
Sara Galindo ◽  
Francisco Blázquez ◽  
Margarita Calonge ◽  
...  
Keyword(s):  
Legal Framework ◽  
Eye Diseases ◽  
The European Union ◽  
Medicinal Products ◽  
Therapeutic Approaches ◽  
Advanced Therapy Medicinal Products ◽  
Advanced Therapy ◽  
Innovative Products ◽  
Somatic Cell Therapy ◽  
Human Use

Advanced therapy medicinal products (ATMPs) are a group of innovative and complex biological products for human use that comprises somatic cell therapy medicinal products, tissue engineered products, gene therapy medicinal products, and the so-called combined ATMPs that consist of one of the previous three categories combined with one or more medical devices. During the last few years, the development of ATMPs for the treatment of eye diseases has become a fast-growing field as it offers the potential to find novel therapeutic approaches for treating pathologies that today have no cure or are just subjected to symptomatic treatments. Therefore, it is important for all professionals working in this field to be familiar with the regulatory principles associated with these types of innovative products. In this review, we outline the legal framework that regulates the development of ATMPs in the European Union and other international jurisdictions, and the criteria that each type of ATMP must meet to be classified as such. To illustrate each legal definition, ATMPs that have already completed the research and development stages and that are currently used for the treatment of eye diseases are presented as examples.

scholarly journals Clinical Development of Advanced Therapy Medicinal Products in Europe: Evidence That Regulators Must Be Proactive

2012 ◽  
Vol 20 (3) ◽  
pp. 479-482 ◽  
Author(s):  
Romaldas Maciulaitis ◽  
Lucia D'Apote ◽  
Andrew Buchanan ◽  
Laura Pioppo ◽  
Christian K Schneider
Keyword(s):  
Clinical Development ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Advanced Therapy
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