1363PD - EMA support for early access for oncology products

Date 08 October 2016
Event ESMO 2016 Congress
Session Public health and health economics
Topics Bioethics, Legal, and Economic Issues
Presenter Steffen Thirstrup
Citation Annals of Oncology (2016) 27 (6): 474-482. 10.1093/annonc/mdw387
Authors S. Thirstrup
  • Nda Advisory Board, NDA Advisory Services Ltd, KT22 9DF - Leatherhead/GB

Abstract

Background

Access to new, innovative, medicines potentially fulfilling unmet medical needs are of paramount importance to patients. European patients will on average have to wait 6 to12 months as compared to their US counterparts to get access to new anti-cancer products. While the US FDA have introduced a number of procedures to shorten the review time, the European Medicines Agency has only recently embarked upon such efforts.

Methods

Following years of discussion on what has been termed 'adaptive licensing', the European Medicines Agency (EMA) launched a new process in March 2016 to support development, and potentially faster regulatory review and approval time was introduced by the EMA. The process has been termed PRIME (PRIority MEdicine) and contains a number of changes to the traditional sponsor-agency relationship.

Results

PRIME includes early access to EMA scientific advice as well as early appointment of the future EU rapporteur who will be leading the regulatory review of any future marketing authorisation. For small/medium size companies as well as academic institutions developing new medicines, access to scientific advice (at reduced or fully waived fee) will be possible at the stage of 'proof of principle' (i.e. prior to Phase 1) whereas large pharma can enter the scheme at the stage of 'proof of concept' (i.e. around Phase 2).

Conclusions

The PRIME scheme was launched in spring 2016 and a number of projects were selected as appropriate for inclusion. Whether this process will lead to earlier access to new, innovative medicines for patients with clear unmet medical need is too early to say. At any rate, this process is the first attempt by EU regulators to optimise the use of the current medicines legislation to foster innovation and hopefully improve review time for medicines in areas with high unmet medical needs such as oncology.

Clinical trial identification

n/a

Legal entity responsible for the study

N/A

Funding

NDA Advisory Services Ltd

Disclosure

S. Thirstrup: I work as a full-time employee for NDA Advisory Services Ltd, which is a global scientific and regulatory consultancy firm for the pharmaceutical industry. I do not receive any direct payment for my work from pharmaceutical developers and/or manufacturers.