[More openness about the registration of drugs in the Netherlands. College for the Review of Medicinal Products].
The applications submitted to the Drugs Evaluation Board contain information that is important for correct use of the drug in question in clinical practice. Not all this information is given in the published literature, certainly not at the time of registration. Recently, legal provisions on publication of data in connection with a registration were clarified. The Board no longer sees any objection to introduction of a national, public assessment report explaining the arguments involved. The quality of evaluation of pharmaceutical products, also in connection with the reimbursement system, cannot but improve if a justification of the evaluation is published.
College ter Beoordeling van Geneesmiddelen, Den Haag.
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Lekkerkerker
D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D009426:Netherlands; D004364:Pharmaceutical Preparations / Q000592:standards*; D011643:Publishing / Q000331:legislation & jurisprudence*; D012042:Registries
D004364:Pharmaceutical Preparations
Meer openheid over de registratie van geneesmiddelen in Nederland. College ter Beoordeling van Geneesmiddelen.