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The impact of Regulation (EC) No 1394/2007 on the development of Advanced Therapy Medicinal Products (ATMPs): an academic perspective

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Next-generation medicines

Technological advances in the field of biology and translational research have led to a new era of therapeutic modalities. As most of these approaches are designed and developed in academic institutes, the EU needs to ensure that good manufacturing practice (GMP) health standards are maintained.

Health

Advanced therapy medicinal products (ATMPs) are novel pharmaceuticals that are based on gene therapy, somatic cell therapy or tissue engineering technologies. Since the development of these products is often exclusively performed by academic facilities, the Regulation (EC) No 1394/2007 has been designed to ensure the free movement of ATMPs within the EU market. At the same time, in order to ensure their quality, safety and efficacy, this regulation extends standards of GMP to ATMPs. However, this GMP compliance extends beyond the academic perspective and creates financial and managerial pressures on academia. The key objective of the EU-funded (ACADEMIC GMP project was to assess the impact of this Regulation on academic GMP facilities. For this purpose, partners conducted a survey of all institutions engaged in ATMP design and manufacture, and performed in-depth interviews with selected experts. Along with this survey, a public conference in Brussels in 2012, titled 'The Impact of EU legislation on Therapeutic Advance', as well as a series of workshops focusing on GMP were held. The idea was to disseminate the scope and activities of ACADEMIC GMP to the scientific community and to foster debate on ATMP-related issues and legislation. The consortium formulated a comprehensive report with details of the performed analyses regarding ATMP regulation, emphasised unforeseen consequences and proposed improvement measures. Recommendations aimed to assist the European Commission to further develop the current EU legislation were also included. It was evident that academic institutions are the major contributors of a large number of ATMPs and are also responsible for their translation to early-phase clinical trials. The consortium therefore proposed that the interaction between academia and industry should be nurtured and better defined, and European collaborations with institutes hosting GMP facilities should be greatly encouraged. ACADEMIC GMP work succeeded in mapping the ATMP landscape, offering an electronic tool of openly accessible data for the perusal of policymakers and researchers. A new FP7 project — Advanced therapy medicinal product good manufacturing practice open access research alliance (AGORA) — has been approved to continue the work accomplished by ACADEMIC GMP.

Keywords

Advanced therapy medicinal product, good manufacturing practice, health standards, pharmaceutical, translational research

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