EMA Adaptive Licensing Fast Tracking Orphan Drugs

EMA Adaptive Licensing presents new orphan drug fast track route

In Market Access, Regulation & Government, Uncategorized by Yolanda King

The European Medicines Agency (EMA) announced an adaptive licensing pilot project on 19th March, which will explore the adaptive licensing procedure for conditions with unmet medical need. Therefore presenting a new flexible pathway for orphan drug fast track market access.

The EMA is currently inviting companies to participate in its pilot project, which intends to explore a progressive licensing approach, with medicines already in development. This will enable them to apply real world data and build on regulatory processes already in place. The scheme wishes to engage with experimental medicines in the early stage of clinical development and as time moves on, they hope to further refine the adaptive licensing pathway, making it compatible with a range of medicines.

The process which underpins the adaptive licensing pathway requires involvement from all stakeholders, such as patient organisations, industry sectors and health technology assessment bodies. The EMA stated that they hope to facilitate this, in a ‘safe harbor environment, enabling exploration of the strengths and weaknesses of all options available throughout the drug development process, from conception to reimbursement. 

Esteban Herrero-Martinez from the Bio Industry Association welcomed the new plans, stating that ‘adaptive licensing could be a significant tool in the armoury to support more efficient medicine development and licensing.’ It is true, the potential of the scheme is vast. If drug developers can gain early access to licensing and the market, it will ensure faster access for patients to innovative medicines, which is a main factor when considering the impact this scheme could potentially have. The new is welcomed within the industry, as it sends a clear signal that the system is changing in order to facilitate access and meet patients medical needs quicker and more efficiently.

The EMA Adaptive Licensing is not the only fast track scheme to be introduced this year, the UK Early Access to Medicines Scheme was also launched in March, enabling swifter access to innovative drugs. If your interested in learning more about these schemes, sign up to our inaugural Fast Tracking Orphan Drugs Briefing on July 10th and engage in discussion with industry experts, as to how the new schemes will work and what opportunities are available for you. Click here to download a brochure for the event.

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