PRIME Addressing patients’ needs PRIME aims to bring promising medicines that meet regulatory requirements to patients earlier by optimising and supporting their development. The scheme focuses on medicines that address an unmet medical need and that have the potential to bring a major therapeutic advantage to patients. With PRIME, EMA translates scientific advances into the development of medicines that can make a real difference to patients’ lives.
96
requests processed (between April 2016 and April 2017)
May
4
14
June
2
July
2
7 1
September
2
7
October
6
December 1
6
February
2
March
(by type of medicine)
12 biological medicines 2 (of which 1 orphan medicine) chemical medicines which 3 orphan medicines) 5 (of 1 vaccine
advanced therapies (of which 8 orphan medicines)
1 in 3
medicines targets a disease for which no treatment exists
PRIME medicines
(by therapeutic area) Oncology
Haematology/Haemostaseology 6
2
Neurology 2 8 1 Gastroenterology/Hepatology 2
3 4
April 1
4 Granted
22%
Denied
Out of scope
success rate
requests denied
71
20 requests granted
6
6
November 1
2
The European Medicines Agency (EMA) developed its PRIority MEdicines (PRIME) scheme in line with the European Commission's priorities and the European medicines regulatory network’s strategy to 2020.
6 1
3
January
The first 12 months
(multiple reasons in some cases)
~70% Data not sufficiently robust ~40% Justification of therapeutic advantage insufficient ~20% Development too advanced
PRIME - The first 12 months - European Medicines Agency
>PRIME aims to bring promising medicines that meet regulatory requirements to patients earlier by optimising and supporting their development. >The scheme ...
Apr 28, 2017 - 2. The United Kingdom will then become a 'third country'. 3. Preparing for the withdrawal is therefore not just a matter for EU and national authorities, but also for private parties. In view of the considerable uncertainties, in parti
May 30, 2017 - Pharmaceutical companies are invited to present their pre-clinical data pertaining to ... patients per year, as many questions about the best use of ALK ... of knowledge and evidence to support the planning and regulatory.
Mar 8, 2018 - Treatment of uterine fibroids. Haematology. New medicines authorised. ⢠Adynovi (rurioctocog alfa pegol). Treatment and prevention of bleeding in patients with haemophilia A. New information on authorised medicines. ⢠Feraccru (ferr
Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...
Treatment of cystine crystal deposits in the eye. New information on authorised medicines. Lucentis (ranibizumab) - change in indication. Treatment of visual ...
The new EudraVigilance system and the electronic reporting of individual case ... the ISO/ICH E2B(R3) format: hands-on training course - October 2017 ... granted a conditional marketing authorisation on the basis of less complete clinical data ...
4 days ago - EMA/CAT/426129/2018. Page 2/17. Table of contents. 1. Introduction. 5. 1.1. Welcome and declarations of interest of members, alternates and ...
Sep 8, 2016 - 3-year report on Pharmacovigilance activities. Helen Lee, European Commission. â¢. Scanning the horizon for 2016 â 2018. Peter Arlett, EMA.
PCWP and HCPWP joint meeting - Sept 2016 - meeting documents. ⢠Workshop on identifying opportunities for 'big data' in medicines development and ...
Used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss .... EMA's Business Continuity Plan for Brexit published.
On arriving for your meeting at 30 Churchill Place, please report to reception where you will be issued with an access pass. This pass will allow you to enter our industry lounge, which you are welcome to utilise during your visit. The industry loung
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a ... Withdrawal of applications for new medicines .... fifth annual regulatory conference on optimising the development of advanced therapies to.
Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a desktop news reader. For a list of RSS readers please refer to ...
May 11, 2017 - Send a question via our website www.ema.europa.eu/contact ...... serotype 5 containing partial E1A deletion and an integrin-binding domain, EMA/OD/251/14 ...... the Community Register of Orphan Medicinal Products if it is ...
Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc.
Jun 18, 2018 - 27. 7.8.1. List of all applications submitted/expected and the COMP coordinatorship distribution of .... 5,10-dihydrodibenzo[b,e][1,4] diazepin-11-one, EMA/OD/031/10 Glutathione-pegylated ...... Abbreviations / Acronyms.
the following public service principles for the EU civil service drawn up by the ... takes into account the experience of the EU network of regulatory agencies ..... 3 The European Medicines Agency Policy on access to documents (related to ...
May 11, 2017 - Send a question via our website www.ema.europa.eu/contact ... Additional details on some of these procedures will ...... Any other business. 22.
