European Drug Administration launches pilot project of adaptive licensing

Source: China Association for the promotion of drugs March 24, 2014 to promote patients to obtain new drugs in time: European Drug Administration (EMA) is inviting some companies to participate in its pilot project of adaptive licensing Companies interested in participating in the pilot need to submit real drug development project plans that are expected to be pilot projects EMA has published a framework of guidelines for individual pilot study discussions Adaptive licensing, sometimes referred to as cross approval or progressive licensing, is part of EMA's efforts to improve patients' access to new drugs in a timely manner It is a process of pre planning for early authorization of drug trials in a defined patient population, and subsequent iterations of evidence collection and adjustment of the applicable patient population for marketing approval to expand the scope of applicable patients As a comprehensive approach, adaptive licensing requires the participation of all stakeholders including EMA, pharmaceutical industry, health technology assessment (HTA), clinical treatment guide and patient organization All discussions will be in a "safe harbor" environment, allowing free exploration and confidentiality of the merits and demerits of all projects in the development, evaluation, licensing, reimbursement, monitoring and available routes of the drug, without the commitment of either party "With the launch of the adaptive licensing pilot project, we plan to explore real drugs in the development of incremental licensing options that allow patients to get timely access to new drugs that treat serious diseases and do not meet medical needs," explains Hans Georg Eichler, the agency's top medical officer "This approach aims to maximize the positive impact of new drugs on public health by balancing timely access to patients with information that provides them with sufficient benefits and risks in development." Adaptive licensing is based on existing regulatory procedures and plans to expand the use of already used elements including scientific advice, the use of centralized guidance, conditional marketing licensing mechanisms (drugs for life-threatening diseases), patient registration and pharmacovigilance tool development for real-life data collection and risk management programs The agency plans to include as many necessary projects as possible in the pilot phase to gain sufficient understanding and experience, solve a series of technical and scientific problems, and further refine the design of adaptive licensing approaches for different types of products and indications The ongoing drug development plan submitted by the company shall be the experimental drug in the early clinical development stage, i.e the early stage before the start of the validation study, so as to facilitate the intervention of stakeholders With the development of the project, the European Commission will work with EU Member States and review the legal and policy issues of adaptive licensing in consultation with the necessary relevant stakeholders 163410.pdf