236 related articles for article (PubMed ID: 24447908)
1. Critical review on the Environmental Risk Assessment of medicinal products for human use in the centralised procedure.
Caneva L; Bonelli M; Papaluca-Amati M; Vidal JM
Regul Toxicol Pharmacol; 2014 Apr; 68(3):312-6. PubMed ID: 24447908
[TBL] [Abstract][Full Text] [Related]
2. Granting marketing authorisation for medicines in South East European countries: the point of view of the authority.
Tomić S; Sucić AF; Martinac AI
Regul Toxicol Pharmacol; 2010; 57(2-3):325-32. PubMed ID: 20385190
[TBL] [Abstract][Full Text] [Related]
3. Where is industry getting it wrong? A review of quality concerns raised at Day 120 by the Committee For Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products.
Borg JJ; Robert JL; Wade G; Aislaitner G; Pirozynski M; Abadie E; Salmonson T; Vella Bonanno P
J Pharm Pharm Sci; 2009; 12(2):181-98. PubMed ID: 19732496
[TBL] [Abstract][Full Text] [Related]
4. European Union centralised procedure for marketing authorisation of oncology drugs: an in-depth review of its efficiency.
Netzer T
Eur J Cancer; 2006 Mar; 42(4):446-55. PubMed ID: 16129598
[TBL] [Abstract][Full Text] [Related]
5. [The role of the Committee for Medicinal Products for Human Use (CHMP) in the European centralised procedure].
Enzmann H; Schneider C
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2008 Jul; 51(7):731-9. PubMed ID: 18584106
[TBL] [Abstract][Full Text] [Related]
6. Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products.
Ceci A; Felisi M; Catapano M; Baiardi P; Cipollina L; Ravera S; Bagnulo S; Reggio S; Rondini G
Eur J Clin Pharmacol; 2002 Nov; 58(8):495-500. PubMed ID: 12451425
[TBL] [Abstract][Full Text] [Related]
7. EU marketing authorization review of orphan and non-orphan drugs does not differ.
Putzeist M; Mantel-Teeuwisse AK; Llinares J; Gispen-De Wied CC; Hoes AW; Leufkens HG
Drug Discov Today; 2013 Oct; 18(19-20):1001-6. PubMed ID: 23835230
[TBL] [Abstract][Full Text] [Related]
8. Health-related quality of life and other patient-reported outcomes in the European centralized drug regulatory process: a review of guidance documents and performed authorizations of medicinal products 1995 to 2003.
Szende A; Leidy NK; Revicki D
Value Health; 2005; 8(5):534-48. PubMed ID: 16176492
[TBL] [Abstract][Full Text] [Related]
9. The environmental risk assessment of human pharmaceuticals in the overall EU regulatory affairs process.
Laenge R; Steger-Hartmann T; Schweinfurth H
Regul Toxicol Pharmacol; 2006 Aug; 45(3):223-8. PubMed ID: 16716476
[TBL] [Abstract][Full Text] [Related]
10. The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011-2018.
Schuster Bruce C; Brhlikova P; Heath J; McGettigan P
PLoS Med; 2019 Sep; 16(9):e1002873. PubMed ID: 31504034
[TBL] [Abstract][Full Text] [Related]
11. [The use of nanotechnology in medicinal products in the light of European Union law].
Jurewicz M
Pol Merkur Lekarski; 2014 Dec; 37(222):369-72. PubMed ID: 25715580
[TBL] [Abstract][Full Text] [Related]
12. Ophthalmic medicine regulatory approvals through the European Centralised Procedure, 1999-2017: Clinical efficacy considerations.
Morgan-Warren PJ
Eur J Ophthalmol; 2020 Mar; 30(2):321-349. PubMed ID: 30832499
[TBL] [Abstract][Full Text] [Related]
13. Non-clinical Post-Marketing Commitments for newly licenced pharmaceuticals.
Reeve LM
Regul Toxicol Pharmacol; 2009 Nov; 55(2):181-7. PubMed ID: 19589365
[TBL] [Abstract][Full Text] [Related]
14. A full-document analysis of the semantic relation between European Public Assessment Reports and EMA guidelines using a BERT language model.
Bergman E; Pasmooij AMG; Mol PGM; Westman G
PLoS One; 2023; 18(12):e0294560. PubMed ID: 38100432
[TBL] [Abstract][Full Text] [Related]
15. Environmental risk assessment of advanced therapies containing genetically modified organisms in the EU.
Whomsley R; Palmi Reig V; Hidalgo-Simon A
Br J Clin Pharmacol; 2021 Jun; 87(6):2450-2458. PubMed ID: 33600022
[TBL] [Abstract][Full Text] [Related]
16. Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe.
Francisca RDC; Baba E; Hoeve CE; Zomerdijk IM; Sturkenboom MCJM; Straus SMJM
Drug Saf; 2021 Jan; 44(1):63-72. PubMed ID: 33000427
[TBL] [Abstract][Full Text] [Related]
17. Legal requirements for the quality of herbal substances and herbal preparations for the manufacturing of herbal medicinal products in the European union.
Vlietinck A; Pieters L; Apers S
Planta Med; 2009 Jun; 75(7):683-8. PubMed ID: 19204891
[TBL] [Abstract][Full Text] [Related]
18. Changing paradigms in bioequivalence trials submitted to the EMA for evaluation - A clinical and regulatory perspective.
Refalo N; Chetcuti D; Tanti A; Serracino-Inglott A; Borg JJ
Saudi Pharm J; 2017 Feb; 25(2):280-289. PubMed ID: 28344480
[TBL] [Abstract][Full Text] [Related]
19. Hurdles of environmental risk assessment procedures for advanced therapy medicinal products: comparison between the European Union and the United States.
Iglesias-Lopez C; Obach M; Vallano A; Agustí A; Montané J
Crit Rev Toxicol; 2019 Aug; 49(7):580-596. PubMed ID: 31846383
[TBL] [Abstract][Full Text] [Related]
20. [Cancer: Is it really so different? Particularities of oncologic drugs from the perspective of the pharmaceutical regulatory agency].
Enzmann H; Broich K
Z Evid Fortbild Qual Gesundhwes; 2013; 107(2):120-8. PubMed ID: 23663906
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]