Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 20-23 June 2016
During its June 2016 meeting, the CHMP reviewed 8 recommendations for eligibility to PRIME: 2 were granted and 6 were denied. In addition, 1 request was received but not started by EMA as it was deemed outside the scope of the scheme. The individual outcomes adopted this month are listed below.
Stomatitis Virus with Envelope Glycoprotein replaced by Zaire ebolavirus (Kikwit Strain) Glycoprotein * Name of the active substance, INN, common name, chemical name or company code. SME applicants are micro-, small-and medium-sized-enterprises registered with the Agency’s SME office. Other types of applicants are those not qualifying or not registered as SME.
Recommendations on eligibility to PRIME scheme EMA/424592/2016
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Eligibility denied Substance type
Biological
Therapeutic area
Oncology
Therapeutic indication
Treatment of small cell lung cancer
Type of data
Type of
supporting request
applicant
Nonclinical +
SME
Clinical exploratory Chemical Advanced Therapy
Oncology Oncology
Prevention/treatment of oral mucositis in head and neck
Nonclinical +
cancer patients receiving radiation- and/ or chemo-therapy
Clinical exploratory
Treatment of metastatic renal carcinoma (mRCC)
Nonclinical +
SME SME
Clinical exploratory Chemical
Oncology
Treatment of symptomatic tenosynovial giant cell tumour
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.
Recommendations on eligibility to PRIME scheme EMA/424592/2016
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Cumulative overview of recommendations on PRIME eligibility requests received as of 3 May 2016
By therapeutic area
By type of applicant
By therapeutic area
* 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 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/424592/2016
Recommendations on eligibility to PRIME scheme - European ...
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.
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
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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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