Westferry Circus Canary Wharf London E HB United Kingdom An agency of the European Union Telephone Facsimile mail press ema

Westferry Circus Canary Wharf London E HB United Kingdom An agency of the European Union Telephone      Facsimile     mail press ema Westferry Circus Canary Wharf London E HB United Kingdom An agency of the European Union Telephone      Facsimile     mail press ema - Start

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Westferry Circus Canary Wharf London E HB United Kingdom An agency of the European Union Telephone Facsimile mail press ema




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Presentations text content in Westferry Circus Canary Wharf London E HB United Kingdom An agency of the European Union Telephone Facsimile mail press ema


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7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 84 27 Facsimile +44 (0)20 7418 8409 mail press @ema.europa.eu Website www.ema.europa.eu 19 March 2014 EMA/430892/2013 Press Office Press release European Medicines Agency launches adaptive licensing pilot project mproving timely access for patient to new medicines : p ilot explore adaptive licensing approa ch with real medicines in development The European Medicines Agency (EM A) is inviting companies to participate in its adaptive licensing pilot project .

Companies who are interested in participating in the pilot are requested to submit ongoing medicine development programmes for consideration as prospective pilot cases. A fra mework to guide discussion of individual pilot studies has been published . The adaptive licensing approach , sometimes called staggered approval or progressive licensing, is part of the Agency’s efforts to improve timely access for patients to new medicin es . It is a prospectively planned process , starting with the early authorisation of a medicine in a restricted patient population, followed by iterative phases of

evidence gathering and adaptations of the marketing authorisation to expand access to the med icine to broader patient populations. As a holistic approach, a daptive licensing requires the involvement of all stakeholders who have a role in determining patient access, including the EMA, the industry, health technology assessment (HTA) bodies organ isations issuing clinical treatment guidelines and patient organisations . All d scussions will take place in a safe harbour environment to allow free exploration of the strengths and weaknesses of all opt ions for development, assessment , licensing,

reimb ursement, monitoring, and utilisation pathways in a confidential manner and without commitment from either side . With the adaptive licensing pilot project we intend to explore with real medicines in development a progressive licensing approach that would allow timely access for patients to new medicines that address serious conditions with unmet medical need ” explains Hans Georg Eichler, the Agency’s Senior Medical Officer The approach seeks to maximize the positive impact of new medicines on public h ealth by balancing timely access for patients with the need to provide adequate

evolving information on the ir benefits and risks Adaptive licensing builds on existing regulatory processes and intends to extend the use of elements that are already in pla ce, including scientific advice, centralised compassionate use, the c onditional arketing uthorisation mechanism (for medicines addressing life threatening conditions patients
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European Medicines Agency launches adaptive licensing pilot project EMA/430892/2013 Page registries and pharmacovigilance tools that allow collection of real life da ta and development of risk management plans The Agency intends to

include as many programmes as necessary in this pilot phase in order to gather sufficient knowledge and experience , address a range of technical and scientific questions and further refine how the adaptive licensing pathway should be designed for different types of products and indications. Ongoing medicine development programmes submitted by companies should be experimental medicines in the early stage of clinical development i.e., prior to the initiation of confirmatory studies to enable actionable input from relevant stakeholders. As the project progresses, t he European Commission will

examine the legal and policy aspects related to adaptive licensing in collaboration with the EU Member States and by consultation with relevant stakeholders, as necessary Notes 1. This press release, together with all related documents, is available on the Agency's website 2. The framework document to guide discussions of individual pilot studies and application form are available on the Agency's website at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_ topics/general/general_content_00 0571.jsp&mid=WC0b01ac0580665b62 3. More information on the work of the European Medicines

Agency can be found on its website: www.ema.europa.eu Contact our press officers Monika Bens tetter or Martin Harvey Tel. +44 (0)20 7418 8427 mail: press@ema.europa.eu


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