Konijnendijk A, Lekkerkerker J F
College ter Beoordeling van Geneesmiddelen, Den Haag.
Ned Tijdschr Geneeskd. 1998 Jul 11;142(28):1621-3.
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.
提交给药品评估委员会的申请包含在临床实践中正确使用相关药物的重要信息。并非所有这些信息都在已发表的文献中给出，当然在注册时肯定没有。最近，与注册相关的数据发布的法律规定得到了澄清。委员会不再反对引入一份解释相关论据的国家公开评估报告。如果评估的理由得以公布，药品评估的质量，包括与报销制度相关的质量，必然会得到提高。
