Exploratory assessment of the current EU regulatory framework for development of advanced therapies

1969 ◽  
Vol 16 (4) ◽  
Author(s):  
Pawanbir Singh ◽  
Laure Brévignon-Dodin ◽  
Satya P Dash
Keyword(s):  
Regenerative Medicine ◽  
Research And Development ◽  
Regulatory Framework ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Regulatory Strategy ◽  
Technology Changes ◽  
Advanced Therapy ◽  
Advanced Therapies ◽  
The Eu

The Advanced Therapy Medicinal Products (ATMP) Regulation provides a necessary regulatory framework for the commercialisation and use of regenerative medicine-based therapeutic products in the EU. However, concerns have been raised about the appropriateness of the regulatory strategy it has adopted to address different, complex and evolving categories of medicinal products. This article explores some of the potential shortfalls of the ATMP Regulation with regard to facilitating the research and development of advanced therapies in the present and in the future. It concludes that while providing a much needed harmonised regulatory framework for the companies operating in the sector, the new regulation has yet to demonstrate its capacity to keep up with radical technology changes.

Exploring Solutions to Foster ATMP Development and Access to Patients in Europe

2020 ◽  
Vol 27 (3) ◽  
pp. 259-273
Author(s):  
Vincenzo Salvatore
Keyword(s):  
Research And Development ◽  
Success Rate ◽  
Critical Factors ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Legislative Reform ◽  
Eu Regulation ◽  
Advanced Therapy ◽  
The Eu

Abstract There are several critical factors that have influenced the (un)success rate of advanced therapy medicinal products (ATMPs) over the first ten years since the EU Regulation 1394/2007 entered into force. This article provides an overview of the current regulatory scenario and outlines the outstanding challenges to be faced in order to further promote research and development of ATMPs and the issues to be considered in the perspective of a possible legislative reform.

The Magistral Preparation of Advanced Therapy Medicinal Products (ATMPs)

2020 ◽  
pp. 1-7
Keyword(s):  
Marketing Authorisation ◽  
Health Care Systems ◽  
Human Keratinocytes ◽  
Public Health Care ◽  
Medicinal Products ◽  
Bacteriophage Therapy ◽  
Access To Treatment ◽  
Advanced Therapy Medicinal Products ◽  
Advanced Therapy ◽  
Advanced Therapies

Advanced Therapy Medicinal Products (ATMPs) embody innovative therapies that have created great hope for patients suffering from previously untreatable diseases. Unfortunately, the pharaonic cost to produce and authorise ATMPs is a challenge for both patients and public health care systems, ultimately reducing patients’ access to treatment. Over the last 11 years, only 15 ATMP marketing authorisation applications received a positive draft opinion from the European Medicines Agency’s (EMA’s) Committee for Advanced Therapies (CAT). Moreover, due to poor return on investment, several ATMPs have already been removed from the market. In addition to the centralised procedure to obtain a marketing authorisation, the legislator foresees an alternative route for authorising ATMPs, the so-called “ATMP Hospital Exemption”. However, such ATMPs must be produced on a limited scale, on a non-routine basis. As a result, valuable ATMP therapies that have been used for years in hospitals may disappear. To avoid this, we propose, in this paper, an additional possibility to regularise ATMPs: the “Magistral Preparation of ATMPs”. It is a feasible pathway, which was already proposed for bacteriophage therapy, and which is particularly suitable for personalised therapies and considerably decreases the cost of the final products. We also discuss the practical impact of the ATMP regulation for (for-profit) industries and for (non-profit) hospitals. Two practical examples, the cultured human chondrocytes and the cultured human keratinocytes, are discussed.

scholarly journals 3D Bioprinting Regulations: a UK/EU Perspective

2017 ◽  
Vol 8 (2) ◽  
pp. 441-447 ◽  
Author(s):  
Phoebe LI ◽  
Alex FAULKNER
Keyword(s):  
Tissue Engineering ◽  
Regenerative Medicine ◽  
Medical Device ◽  
3D Bioprinting ◽  
Medicinal Products ◽  
Legal Regime ◽  
Advanced Therapy ◽  
Regulatory Instruments ◽  
The Eu ◽  
Medical Device Regulation

AbstractThis report introduces the challenges 3D bioprinting poses to the existing legal regime across bioethics, safety, regenerative medicine, and tissue engineering. We briefly review the 3D bioprinting technology and look into the relevant regulatory instruments for the pre-printing, printing, and post-printing stages. Special attention is paid to the applications of the EU Advanced Therapy Medicinal Products Regulation and the new Medical Device Regulation.

scholarly journals PPM11 Market Access Landscape for Advanced Therapy Medicinal Products in the EU-5

2020 ◽  
Vol 23 ◽  
pp. S688-S689
Author(s):  
F. Benazet ◽  
I. Berard ◽  
M. Prada ◽  
A. Ricci ◽  
S. Walzer ◽  
...  
Keyword(s):  
Market Access ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Advanced Therapy ◽  
The Eu

Access to Advanced Therapy Medicinal Products in the EU: Where Do We Stand?

2011 ◽  
Vol 18 (3) ◽  
pp. 305-317 ◽  
Author(s):  
A. Mahalatchimy
Keyword(s):  
The European Union ◽  
Medicinal Products ◽  
Wide Margin ◽  
Advanced Therapy Medicinal Products ◽  
Global Policy ◽  
Health Strategy ◽  
Advanced Therapy ◽  
The One ◽  
High Level ◽  
The Eu

AbstractThe European Union has a public health strategy and will generally ensure in all its policies and activities a “high level of human health protection”. The new Regulation (EC) no 1394/2007 on advanced therapy medicinal products (ATMP), stems from this global policy and aims to harmonise access to the ATMP market. A real will for the harmonisation is clearly expressed in legal texts and enforced in the implementable procedures and requirements. However, several barriers remain. On the one hand, the scope of the ATMP Regulation is limited. On the other hand, Member States benefit from a wide margin of action.

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