16 October 2017 EMA/675761/2017 Human Medicines Evaluation Division
PRIME eligibility requests 2018 Deadlines for submission and timetable for assessment
Deadline for
Start of procedure
SAWP
CAT
CHMP
submission
(SAWP meeting)
recommendation
recommendation(*)
adoption
03/01/2018
8 – 11 January 2018
08/02/2018
16/02/2018
22/02/2018
31/01/2018
5 – 8 February 2018
08/03/2018
16/03/2018
22/03/2018
28/02/2018
5 – 8 March 2018
12/04/2018
20/04/2018
26/04/2018
04/04/2018
9 – 12 April 2018
17/05/2018
25/05/2018
31/05/2018
06/05/2018
14 – 17 May 2018
14/06/2018
22/06/2018
28/06/2018
06/06/2018
11 – 14 June 2018
12/07/2018
20/07/2018
26/07/2018
04/07/2018
9 – 12 July 2018
06/09/2018
14/09/2018
20/09/2018
29/08/2018
3 – 6 September 2018
04/10/2018
12/10/2018
18/10/2018
26/09/2018
1 – 4 October 2018
31/10/2018
09/11/2018
15/11/2018
24/10/2018
29 – 31 October 2018
29/11/2018
07/12/2018
13/12/2018
21/11/2018
26 – 29 November
17/01/2019
25/01/2019
31/01/2019
2018 * In case of advanced therapy medicinal products 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5510 Send a question via our website www.ema.europa.eu/contact
>PRIME aims to bring promising medicines that meet regulatory requirements to patients earlier by optimising and supporting their development. >The scheme ...
Mar 15, 2018 - (Article 5(12) (b) of Regulation (EC) No 141/2000 of the European Parliament and of the Council). When a designated orphan medicinal product receives a positive opinion for marketing authorisation from EMA's Committee for Medicinal Pro
Feb 27, 2018 - Tazemetostat for treatment of follicular lymphoma, Quintiles Ireland Limited. 2. Opinions adopted at the first COMP discussion: â¢. Docosahexaenoic acid ethyl ester for treatment of sickle cell disease, TurnKey PharmaConsulting. Irela
Feb 8, 2018 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. Telephone +44 (0)20 3660 6000 ... This document provides current information related to the volume and evaluation of marketing authorisation and ... The purpose
Mar 5, 2018 - it includes the INN (active moiety only, with no information on salt, ester or derivative) and therapeutic area. This list only includes information for medicines whose applications have been validated at the time the report was compile
Jul 12, 2018 - An agency of the European Union ... This list only includes information for medicines whose applications have been validated at the time the.
Jun 22, 2018 - An agency of the European Union. Telephone +44 (0)20 ... Selumetinib for treatment of neurofibromatosis type 1, AstraZeneca AB;. â¢. Synthetic ...
Apr 26, 2017 - supporting request. Type of applicant ... Name of the active substance, INN, common name, chemical name or company code. SME applicants ...
3 days ago - Name*. Substance type. Therapeutic area. Therapeutic indication. Type of data supporting request. Type of applicant. Adeno-associated viral.
Nov 16, 2016 - SME applicants are micro-, small-and medium-sized-enterprises ... of the scheme or with a format and content inadequate to support their.
Nov 15, 2017 - Substance type Therapeutic area. Therapeutic indication. Type of data supporting request. Type of applicant. Autologous T lymphocyte- enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor
Oct 18, 2017 - Additionally, the CHMP reviewed data on progress to proof of concept and confirmed eligibility for A4250 in the treatment of progressive familial intrahepatic cholestasis, which was initially granted eligibility to the scheme at early
Mar 29, 2017 - SME. Chemical. Oncology. Treatment of locally advanced or ... the scope of the scheme or with a format and content inadequate to support.
Jul 26, 2017 - 30 Churchill Place â Canary Wharf â London E14 5EU â United ... Name of the active substance, INN, common name, chemical name or company code. ... of the scheme or with a format and content inadequate to support.
Dec 20, 2017 - Press office. Recommendations on eligibility to PRIME scheme. Adopted at the CHMP meeting of 11-14 December 2017. During its December 2017 ... requests received but not started by EMA as they were deemed outside the scope of the scheme
Jun 29, 2016 - Name of the active substance, INN, common name, chemical name or company code. SME applicants are micro-, small-and medium-sized-enterprises ... of the scheme or with a format and content inadequate to support their.
Jul 4, 2018 - *This indicates eligibility requests received but not started by EMA as they were deemed outside the scope of the scheme or with a format and ...
Mar 1, 2017 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom ... active substance, INN, common name, chemical name or company code. ... of the scheme or with a format and content inadequate to support their.
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
