Corporate Banner
Satellite Banner
Biomolecular Screening
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

European Medicines Agency Launches Adaptive Licensing Pilot Project

Published: Friday, March 21, 2014
Last Updated: Thursday, March 20, 2014
Bookmark and Share
Improving timely access for patients to new medicines: pilot explores adaptive licensing approach with real medicines in development.

The European Medicines Agency (EMA) 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 framework to guide discussions 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 medicines.

It is a prospectively planned process, starting with the early authorization of a medicine in a restricted patient population, followed by iterative phases of evidence gathering and adaptations of the marketing authorization to expand access to the medicine to broader patient populations.

As a holistic approach, adaptive 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, organizations issuing clinical treatment guidelines and patient organizations.

All discussions will take place in a ‘safe harbour’ environment to allow free exploration of the strengths and weaknesses of all options for development, assessment, licensing, reimbursement, monitoring, and utilization 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 needs,” explains Hans-Georg Eichler, the Agency’s Senior Medical Officer.

Eichler continued, “The approach seeks to maximize the positive impact of new medicines on public health by balancing timely access for patients with the need to provide adequate evolving information on their benefits and risks.”

Adaptive licensing builds on existing regulatory processes and intends to extend the use of elements that are already in place, including scientific advice, centralized compassionate use, the conditional marketing authorization mechanism (for medicines addressing life-threatening conditions), patients’ registries and pharmacovigilance tools that allow collection of real-life data 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, the 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.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,300+ scientific posters on ePosters
  • More than 4,900+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Liquid Biopsies: Miracle Diagnostic or Next New Fad?
Thanks to the development of highly specific gene-amplification and sequencing technologies liquid biopsies access more biomarkers relevant to more cancers than ever before.
Gene Terapy for Muscle Wasting Developed
New gene therapy could save millions of people suffering from muscle wasting disease.
Detecting Alzheimer's with Smell Test
Odour identification test may offer low-cost alternative for predicting cognitive decline and detecting early-stage Alzheimer’s disease.
Fighting Cancer Through Protein Pathways
Researchers have found a new drug target within a protein production pathway critical to regulating growth and proliferation of cells.
Mutations in DNA-Repair Genes Found in Advanced Prostate Cancers
New findings indicate that nearly 12% of male advanced prostate cancer sufferers have inherited mutation in DNA-repair genes.
Molecule May Affect Gaucher, Parkinson's Disease
Research has identified a molecule that restores activity of a dysfunctional enzyme linked to Gaucher and Parkinson's disease.
Targeting BRAF Mutations in Thyroid Cancer
Treating metastatic thyroid cancer patients harboring a BRAF mutation with vemurafenib showed anti-tumor activity in a third of patients.
Plant Compounds Fight Together Against Colon Cancer
Research shows treating colon cancer cells with curcumin, then silymarin is more effective than treatment with each individually.
New Centre Offers Ultra-Speed Protein Analysis
UW-Madison researchers to establish development centre for next-gen protein measurement technologies.
Drug Candidates Reduce Abnormal Protein Production
New drug candidates improve cell ability to catch miss-folded proteins that could cause deadly diseases.
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!