These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
261 related articles for article (PubMed ID: 27527889)
21. Special considerations concerning regulatory requirements and drug development for peptides and biotech products in the EU. Braun A; Gassmann R; Kraus K; Lorenzi G; Weigel U Pharm Acta Helv; 1996 Dec; 71(6):447-58. PubMed ID: 8997177 [TBL] [Abstract][Full Text] [Related]
22. 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]
23. [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]
26. Future development of global regulations of Chinese herbal products. Fan TP; Deal G; Koo HL; Rees D; Sun H; Chen S; Dou JH; Makarov VG; Pozharitskaya ON; Shikov AN; Kim YS; Huang YT; Chang YS; Jia W; Dias A; Wong VC; Chan K J Ethnopharmacol; 2012 Apr; 140(3):568-86. PubMed ID: 22373513 [TBL] [Abstract][Full Text] [Related]
27. Regulatory experience of handling Risk Management Plans (RMPs) for medicinal products in the EU. Butler D; Vucic K; Straus S; Cupelli A; Micallef B; Serracino-Inglott A; Borg JJ Expert Opin Drug Saf; 2021 Jul; 20(7):815-826. PubMed ID: 33843379 [No Abstract] [Full Text] [Related]
28. Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines. Ehmann F; Sakai-Kato K; Duncan R; Hernán Pérez de la Ossa D; Pita R; Vidal JM; Kohli A; Tothfalusi L; Sanh A; Tinton S; Robert JL; Silva Lima B; Amati MP Nanomedicine (Lond); 2013 May; 8(5):849-56. PubMed ID: 23656268 [TBL] [Abstract][Full Text] [Related]
29. Potential Procedural Efficiencies and Challenges of Combining Multiple Type II Variations into a Single EU-RMP. Marshall R; Atuah KN; Tekumalla SH Pharmaceut Med; 2020 Feb; 34(1):1-5. PubMed ID: 32048215 [TBL] [Abstract][Full Text] [Related]
30. Issues with regulatory pharmacovigilance in East European countries: the industry perspective. Hanzl-Dujmović I; Sulić-Milisić Z; Staresinić-Sernhorst I Toxicol Lett; 2007 Feb; 168(3):228-35. PubMed ID: 17161561 [TBL] [Abstract][Full Text] [Related]
32. [Harmonisation of the Marketing Authorisation Application dossier: perspectives due to harmonised requirements. Assessing Rules and the Common Technical Document]. Menges K Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2008 Jul; 51(7):748-56. PubMed ID: 18584104 [TBL] [Abstract][Full Text] [Related]
33. Traditional herbal medicines worldwide, from reappraisal to assessment in Europe. van Galen E J Ethnopharmacol; 2014 Dec; 158 Pt B():498-502. PubMed ID: 25043781 [TBL] [Abstract][Full Text] [Related]
34. [European Marketing Authorisation: a long process. Experiences of small biotech companies with the ATMP regulation]. Buljovčić Z Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2011 Jul; 54(7):831-8. PubMed ID: 21698536 [TBL] [Abstract][Full Text] [Related]
35. Extrapolation in the development of paediatric medicines: examples from approvals for biological treatments for paediatric chronic immune-mediated inflammatory diseases. Stefanska AM; Distlerová D; Musaus J; Olski TM; Dunder K; Salmonson T; Mentzer D; Müller-Berghaus J; Hemmings R; Veselý R Arch Dis Child; 2017 Oct; 102(10):952-957. PubMed ID: 28554892 [TBL] [Abstract][Full Text] [Related]
36. 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]
38. Regulatory issues surrounding nanomedicines: setting the scene for the next generation of nanopharmaceuticals. Gaspar R Nanomedicine (Lond); 2007 Apr; 2(2):143-7. PubMed ID: 17716116 [No Abstract] [Full Text] [Related]
39. [Review of the development in European Legislation on the harmonisation of the laws for medicinal products]. Lehmann B Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2008 Jul; 51(7):713-21. PubMed ID: 18584107 [TBL] [Abstract][Full Text] [Related]
40. Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises: an analysis of major objections and their impact on outcomes. Amaouche N; Casaert Salomé H; Collignon O; Santos MR; Ziogas C Drug Discov Today; 2018 Oct; 23(10):1801-1805. PubMed ID: 29953957 [TBL] [Abstract][Full Text] [Related] [Previous] [Next] [New Search]