Pharmaceuticals Policy and Law - Volume 12, issue 1,2
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The new international review,
Pharmaceuticals Policy and Law, appears with the aim of studying and evaluating the
legal status of medicinal products in the European Union, and its implications in other markets such as the USA and Japan, without neglecting the specific problems of developing countries.
Pharmaceuticals Policy and Law intends to participate in the process of world convergence of pharmaceutical legislation helped by a network of academic centers specializing in pharmaceutical law, without omitting a scientific, economic and social approach to medicinal products.
The specificity of medicinal products conditions their legal status. Legislation regulating other goods cannot be applied to them. To begin with, they are the result of scientific and technical innovation. Research policies determine their progress. The pharmaceutical industry is, by nature, multinational. But, next to these global trends, different traditions still remain at a national level. Within the EU, barriers to free trade in medicinal products still remain despite more than thirty years of harmonisation. The social dimension of medicinal products is complex and very significant in the preoccupations of our societies. Patenting is essential but not sufficient. The life-cycle of medicinal products is protected by professional responsibility, required in the general concept of health safety. It is important to remember their ethical dimension, including research and innovation in new fields such as genetic manipulation and biotechnology, which requires social consent to preserve human dignity and fundamental rights.
Abstract: The strategy for innovation at EMA is defined in the Pharmaceutical Legislation (Reg (EC) No 726/2004). EMA has also outlined a Road Map up to 2010 with two main objectives: to stimulate research and innovation from pharmaceutical and biotechnology enterprises within Europe, and to address hurdles encountered during innovative drug development . In order to support the activities on innovative products, the pharmaceutical legislation offers the definitions and references for innovative medicines.
Keywords: Innovation, pharmaceutical legislation, Road Map, EMA
Abstract: The Innovative Medicines Initiative is a unique and novel long term european public-private partnership designed by the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The initiative was promoted to accelerate the discovery and development of better medicines by removing bottlenecks in the drug development process. It focuses on creating better methods and tools that improve and enhance the drug development process, rather than on developing specific, new medicines.
Keywords: Innovative Medicines Initiative, Joint Technology Initiative, R&D investment, European Federation of Pharmaceutical Industries and Associations
Abstract: Advanced therapies represent new possibilities of treatment for human disorders. Advanced Therapy Medicinal Products (ATMPs) are novel and complex entities which need to be supported by adequate regulation in order to preserve public health.
Abstract: Following the opinion of the European Parliament on 25 April 2007, the European Council of Ministers approved the Regulation on Advanced Therapies Medicinal Product (ATMP) . The Regulation was translated into all EU official languages and on 30 October 2007 the Advanced Therapy Regulation was formally adopted by the EU Council. The Regulation was published in the EU Official Journal on 10 December 2007. From December 30, 2008, the new European Regulation, (EC) No 1394/2007, applies.…This means that Europe has now a common legislation for this type of products which have previously been handled differently in different countries. For the first time, the ATMP Regulation brings all "advanced therapies" (gene, cellular and tissue-based treatments) together within a single, integrated European regulatory framework, in order to ensue consistency across member states. The implementation plan of ATMP Regulation has been developed and agreed with the European Medicines Agency (EMA), and the a new scientific committee, the Committee on Advanced Therapy (CAT), has been created at the EMA to assess quality, safety and efficacy of advanced medicinal products and to follow scientific developments in the field. The committee will also provide scientific advice to companies developing advanced therapy medicinal products. In Italy it is established that the standard for ATMP development and clinical trials should follow both the specific tailor-made technical requirements of the Regulation and those defined by European Directives on clinical trials, "Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001, 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"  and "Directive 2005/28/EC, laying down principles and detailed guidelines for good clinical practice as regards to investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products" . This implies that GXP rules [Good Manufacturing Practice (GMP) for production, Good Laboratory Practice (GLP) for non clinical safety studies and Good Clinical Practice (GCP) for registration clinical trials] should be followed during development.
Abstract: The necessity of a consistent approach and a regulatory "memory" was addressed by the EU with the promulgation of the Regulation 1394/2007/EC and the creation of a new committee for the evaluation of the Marketing Authorisation Application (MAA) of ATMPs, the Committee for Advanced Therapies (CAT). However, the scientific background of the ATMPs is rapidly changing due to a high rate of innovation. In fact, often the time frame required to perform the clinical development, usually…of at least 5 years, is such that the product or some of its assumption might be obsolete at the moment of the Marketing Application. To favour the Small and Medium Enterprises (SMEs) and academic sponsors, the Regulation contains provisions which are intended to help this transition and to smooth the regulatory hurdles.
Keywords: ATMP, CAT, EMA, preclinical data certification, clinical studies