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Today, the European Commission has adopted the Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMP), one of the initiatives of the Action Plan for ATMPs.
The new Guidelines, developed after extensive consultation with stakeholders, EMA and competent national authorities, adapt the GMP requirements to the specific characteristics of ATMPs and address novel scenarios such as decentralised manufacturing, automated production, and reconstitution of ATMPs. The Guidelines take a risk-based approach, allowing manufacturers some flexibility in their processes and control systems, depending on the level of risk. In addition, the Guidelines describe the traceability data that ATMP manufacturers should keep for 30 years in accordance with Article 15 of ATMP Regulation (EC/1394/2007).
The manufacturing of ATMPs poses unique challenges (e.g. limited availability and intrinsic variability of the starting materials, short shelf-life, very small batch sizes) and the application of GMP has been consistently identified as a problem for ATMP developers. The adaptations introduced in the GMP framework for ATMPs continue ensuring a high level of quality for ATMPs and a high level of patient protection. In addition, the Guidelines are expected to make a significant contribution to the development of these products and will provide increasing opportunities for patients to be enrolled in clinical trials with ATMPs in the EU.
Background:
ATPMs are medical products for human use based on genes or cells that offer potentially ground-breaking opportunities for the treatment of injury and disease, particularly in cases of severe, untreatable or chronic diseases which do not respond adequately to conventional treatments.
In the EU, these products are governed by Regulation 1394/2007 on advanced therapy medicinal products (“ATMP Regulation”). The cornerstone of the Regulation is that a marketing authorisation must be obtained prior to the marketing of ATMPs. The evaluation of these products is led by a specialised committee within the European Medicines Agency (the Committee for Advanced Therapies - “CAT”) and the authorisation is granted by the European Commission. The ATMP Regulation also empowers Member States to permit the use of advanced therapies that have not been authorised by the Commission under certain conditions (so-called "hospital exemption").
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