Wednesday 20 September EMA/668862/2016 Press office
Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 11-14 September 2017
During its September 2017 meeting, the CHMP reviewed 4 recommendations for eligibility to PRIME: 4 were denied. The individual outcomes adopted this month are listed below.
Increase in fistula survival and use for haemodialysis
Nonclinical
SME
+ Clinical exploratory + Clinical confirmatory Chemical
Vaccines
Prevention against Influenza
Nonclinical
SME
+ Clinical exploratory Biological
Oncology
Treatment of stage IV oesophageal carcinoma
Nonclinical
Other
+ Clinical exploratory SME applicants are micro-, small-and medium-sized-enterprises registered with the Agency’s SME office. Other type of applicants are those not qualifying or not registered as SME or not fulfilling the definition of academic sponsors.
Recommendations on eligibility to PRIME scheme EMA/668862/2016
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Cumulative overview of recommendations on PRIME eligibility requests adopted by 14 September 2017 By therapeutic area
By type of applicant
* One eligible product has subsequently been withdrawn from the scheme at the applicant’s request
Out of scope indicates eligibility requests received but not started by EMA as they were deemed outside the scope of the scheme or with a format and content inadequate to support their review. These are not included in the breakdown by type of applicant or by therapeutic area. Recommendations on eligibility to PRIME scheme EMA/668862/2016
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.
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
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.
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.
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>PRIME aims to bring promising medicines that meet regulatory requirements to patients earlier by optimising and supporting their development. >The scheme ...
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