PRIME: new EU scheme for accelerated new drugs assessment/approval
Posted: Thu Jun 23, 2016 1:10 pm
EMA’s PRIME can help speed delivery of new medicines to patients – by Susan Forda (1st March 2016)
Last week, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted the Priority Medicines (PRIME) scheme. PRIME is a welcome step towards connecting healthcare decision-makers to expedite patient access to new medicines – but what sets it apart from other mechanisms with similar aims? The Conditional Marketing Authorisation (CMA) and Accelerated Assessment (AA) texts were also adopted by CHMP last week. With the PRIME text, as well as CMA and AA, to be published in March 2016, it is important to discuss what sets PRIME apart – and what elements are needed to make PRIME a success, not only in principle, but also in practice. In an article for EFPIA, Susan Forda, Vice President, International Regulatory Affairs Eli Lilly and Company, examines the potential of PRIME.
PRIME builds on existing regulatory tools, particularly scientific advice and the accelerated assessment procedure. Through the scheme, EMA will offer early and enhanced scientific and regulatory support to medicine developers to optimise the generation of robust data and enable accelerated assessment. The objectives of PRIME follow the proposed EU Medicines Agencies Network Strategy to 2020, by pursuing timely patient access to new beneficial and safe medicines for patients.
Some have compared the PRIME concept to that of the US Food and Drug Administration’s “breakthrough designation”, which speeds the review process for specific drugs that address serious unmet medical needs. By advising on cutting-edge development earlier in the process, the hope is to translate advances in scientific research into accessible patient treatments more efficiently and effectively than in the past.
Full article: http://efpiamapps.eu/emas-prime-can-hel ... san-forda/
Last week, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted the Priority Medicines (PRIME) scheme. PRIME is a welcome step towards connecting healthcare decision-makers to expedite patient access to new medicines – but what sets it apart from other mechanisms with similar aims? The Conditional Marketing Authorisation (CMA) and Accelerated Assessment (AA) texts were also adopted by CHMP last week. With the PRIME text, as well as CMA and AA, to be published in March 2016, it is important to discuss what sets PRIME apart – and what elements are needed to make PRIME a success, not only in principle, but also in practice. In an article for EFPIA, Susan Forda, Vice President, International Regulatory Affairs Eli Lilly and Company, examines the potential of PRIME.
PRIME builds on existing regulatory tools, particularly scientific advice and the accelerated assessment procedure. Through the scheme, EMA will offer early and enhanced scientific and regulatory support to medicine developers to optimise the generation of robust data and enable accelerated assessment. The objectives of PRIME follow the proposed EU Medicines Agencies Network Strategy to 2020, by pursuing timely patient access to new beneficial and safe medicines for patients.
Some have compared the PRIME concept to that of the US Food and Drug Administration’s “breakthrough designation”, which speeds the review process for specific drugs that address serious unmet medical needs. By advising on cutting-edge development earlier in the process, the hope is to translate advances in scientific research into accessible patient treatments more efficiently and effectively than in the past.
Full article: http://efpiamapps.eu/emas-prime-can-hel ... san-forda/