EditorialRestricted accessEditorialFirst published January, 2015pp. 1-3The Common Technical Document as academic guideline Preview abstractGet AccessAbstract
Research articleRestricted accessResearch articleFirst published January, 2015pp. 5-7Prologue Alberto Ramos-CormenzanaPreview abstractGet AccessAbstract
IntroductionRestricted accessIntroductionFirst published January, 2015pp. 9-15European pharmaceutical harmonisation Fernand SauerPreview abstractGet AccessAbstract
Research articleRestricted accessResearch articleFirst published January, 2015pp. 17-22Regulatory harmonisation for better global health Jose Luis ValverdePreview abstractGet AccessAbstract
Research articleRestricted accessResearch articleFirst published January, 2015pp. 23-31The common technical document as basis of the authorization of marketing of medicinal products in the European Union María Dolores CabezasPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 35-48The administrative information of the registration of a medicinal product dossier María Dolores CabezasPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 49-64Summary María Dolores CabezasPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 65-79Chemical,pharmaceutical and biological information for medicinal products containing chemical and/or biological active substances Antonio Espinosa ÜbedaPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 81-89Pharmaceutical products María Emilia Széliga, Marcelo C. NacucchioPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 91-100Non-clinical reports Maria Dolores HerreraPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 101-116Toxicology Antonio Zarzuelo ZuritaPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 117-152Clinical trials Jaime Algorta Pineda, Ana Belén González Hernández, María Teresa González Martel , [...]View AllPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 155-161Specific marketing authorisation dossiers and requirements A.G. AsueroPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 165-189Particular medicinal products Alfonso Ruiz-Bravo, María Jiménez-ValeraPreview abstractGet AccessAbstract
Research articleRestricted accessResearch articleFirst published January, 2015pp. 191-2121.2. Vaccines Alfonso Ruiz-Bravo, María Jiménez-ValeraPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 213-220Registration dossier for radiopharmaceutical products J. MallolPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 221-229Homeopathic medicines Bienvenido BarelliPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 231-249Herbal medicinal products Mahabir P. GuptaPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 253-264Advanced therapy medicinal products: Gene therapy Antonio Ayala, Mario Muñoz, Sandro Argüelles , [...]View AllPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 265-270Specific requirements regarding module 4 Maria Dolores Herrera GonzálezPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 271-277Specific requirements for somatic cell therapy medicinal products and tissue engineered products Rosa M. Hernández Martín, Eduardo L. Mariño Hernández, José Luis Pedraz Muñoz , [...]View AllPreview abstractGet AccessAbstract
OtherRestricted accessOtherFirst published January, 2015pp. 279-281Specific requirements regarding module 5 Rosa M. Hernández Martín, Eduardo L. Mariño Hernández, José Luis Pedraz Muñoz , [...]View AllPreview abstractGet AccessAbstract