Pharmablue / White papers / Development of Advanced Therapy Medicinal Products in Europe
White papers - 1 March 2018
During the 1990s, new types of innovative medicinal products emerged i.e. tissue-engineered medicinal products and cell therapies. At this time, these innovative products were regulated under national law in each European Member State with different regulatory statuses (i.e. medicinal product, medical device, medical practice, etc.) until 2003 when the European Commission started to focus more attention on these products.
In order to initiate a harmonisation taskforce in 2003, the first definition of tissue-engineered medicinal products and cell therapies was established by the European Commission, according to Annex IV of the Directive 2003/63/EC, modifying the Directive 2001/83/EC. According to the definition, these products fall within the framework of medicinal products and a new class of medicinal products was defined: the ‘Advanced Therapy Medicinal Products’ (ATMPs), which included at this time the tissue-engineered medicinal products and the cell therapies. Due to the emergence of new products, including combined products or tissue-engineered products, the legislation was reinforced to harmonise the European position on the regulatory status and the scientific criteria to be considered for the authorisation of such products and to define the responsibilities of the competent authorities. This resulted in the adoption by the European Commission of Regulation (EC) No 1394/2007, the regulation applicable to ATMPs.
The Regulation was implemented in order to ensure consistency between the existing regulatory frameworks, to harmonise and ease the market access of such products, while ensuring a high level of public health. Approximately 9 years after the implementation of the Regulation, an evaluation of the efficiencies and limitations of the implemented measures can be made. A review of the regulatory requirements specific to ATMPs is provided together with a review of specific experiences with these products and, finally, a quantitative and qualitative evaluation of the incentives in place – the evaluation is based on the report that was prepared by the European Commission five years after the implementation of the Regulation.
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