Please login to the form below

Not currently logged in
Email:
Password:

Consultation begins on new patient access scheme

EMA hopes PRIME will improve development of prioritymedicines and ease access concerns

European Medicines Agency (EMA)

A new European scheme that aims to improve patient access to medicines has been put out to consultation.

The European Medicines Agency's (EMA) Priority Medicines scheme, or PRIME, builds on existing regulatory tools, in particular scientific advice from the accelerated assessment procedure, and aims to strengthen support to medicines that have the potential to benefit patients who have no treatment options, or medicines that may offer a therapeutic advantage over existing treatments.

The regulator believes that “by providing enhanced supported to medicines that address unmet medical needs, [it] will encourage developers to focus their resources on those candidate medicines that are likely to make a real difference to a patient's life”.

Additionally PRIME also aims to strengthen the design of clinical trials so that patients participate in trials that have a greater chance of providing the necessary data for a drug approval application.

The EMA will now bring together a multidisciplinary group of experts from relevant scientific committees to give preliminary guidance on the overall development plan and recommended regulatory pathway of drugs. 

Medicines that receive support from the PRIME scheme will nevertheless still have to demonstrate that their benefits outweigh their risks, which is the same standard applied to all medicines seeking approval in the EU.

In order to enter PRIME medicines would have to meet the same standards set for the accelerated assessment procedure. This means clinical evidence needs to be presented indicating that the medication has the potential to bring significant benefits to patients with unmet medical needs.

The actual launch date of PRIME is set for the beginning of 2016 and ahead of then pharmaceutical companies are able to provide comment until 23 December.

More information on the EMA's Priority Medicine (PRIME) Scheme 

Article by
Nikhil Patel

27th October 2015

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Aptus Health

Aptus Health is dedicated to advancing health engagement. The company offers end-to-end digital health engagement solutions spanning all areas of...

Latest intelligence

Precision paediatrics: Treating patients with CAR-T
Dr Stuart Adams specialises in using T-cell therapy to treat paediatric patients at Great Ormond Street Hospital. Here, he explains what it was like to develop and deliver a groundbreaking...
What does it mean to be an agile organisation
We spoke with Philip Atkinson to learn how healthcare and pharmaceutical companies can rapidly respond to changes in the market....
Battling breast cancer with precision medicine (Part 2)
Dr Mark Moasser treated breast cancer survivor Laura Holmes-Haddad (interviewed in part one) with an innovative precision medicine, which at the time was yet to be approved. Here he gives...

Infographics