Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Regulatory framework for advanced therapy medicinal products (ATMPs) according to the Regulation (EC) No 1394/2007 ***
Dr. Rüdiger Vallon (Abschlußjahr: 2009)
Language: English
New technologies and therapies and biomedical treatments including gene therapy, somatic cell therapy and tissue engineering are evolving rapidly. These advanced therapy medicinal products will have a great impact on the development of regenerative medicine and may provide better means of more personalized treatments and thus may render many debilitating diseases amenable to therapeutic intervention. To mention a few, patients with diseases such as Alzheimers disease, Arthritis, Muscular Dystrophies, certain forms of Cancer but also victims of Skin burns will likely have a huge benefit from these innovative treatments. Even though some ATMPs e.g. gene therapy medicinal products were already within the scope of Regulation (EC) No 726/2004 [8] and thus a Centralized Procedure was mandatory, for other products especially tissue engineered products divergent national approaches applied resulting in different regulatory rules and requirements in different Member States. This has led to the fact that tissue engineered products were classified as medicinal products by some Member States while others regulated them as medical devices resulting in inconsistency and difficulty to put them on the European market. Thus patients access to certain treatments was difficult and the development of the entire biotechnology sector within the Community was impaired. With entering into force of Regulation (EC) No 1394/2007 [1] on 30 December 2007 a pan-European regulatory framework that applies from 30 December 2008 on was established. The overall objective of the Regulation is to improve patients access, provide a leveled playing field and legal certainty for manufactures and finally ensuring the harmonized market access for ATMPs within the Community. The main essentials of the regulatory framework established by Regulation (EC) No 1394/2007[1] are comprised of:
- A centralized marketing authorization for ATMPs valid in the entire Community
- Establishment of a the Committee for Advanced Therapies(CAT) at EMEA, a multidisciplinary committee that assembles the best available experts within the Community for assessing MAA of ATMPs and following the scientific development in the field.
- Requirements for providing new guidelines and provisions for ATMPs and revision of existing ones adopted to the technical characteristics of ATMPs
- Incentives for manufactures of ATMPs mainly tailored towards the need of SMEs
The aim of this thesis is to provide a comprehensive* (*as of June 2009) overview of the new regulatory framework provided through Regulation (EC) No 1394/2007[1]. The major focus will be on quality and risk management related aspects of ATMPs. In addition, other guidelines and provisions are presented and discussed.
Pages: 58,
annexes: 14