[Review of legislation regarding clinical research in the Spanish health care system and hospital pharmacy services].
The call for public funding for the Spanish Health Care System clinical research with drugs for human use projects Subprogramme highlights the need for hospital pharmacy services to include the manufacture of investigational drugs which are the subject of a clinical trial, developed by either a researcher or a group of researchers, within its activities. This article discusses the legislation concerning the manufacture of investigational drugs and the requirements that the pharmacy services must meet in order to develop, distribute, or conceal an investigational drug in a clinical trial sponsored by a professional from the SHS.
Subdirección General de Inspección y Control de Medicamentos, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, España. nlaguna@agemed.es
Noa
N
Laguna-Goya
M Antonia
MA
Serrano
Cristina
C
Gómez-Chacón
D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003695:Delivery of Health Care / Q000331:legislation & jurisprudence*; D006801:Humans; D010607:Pharmacy Service, Hospital / Q000331:legislation & jurisprudence*; D013030:Spain