Nickel Lars, Seibel Yvonne, Frech Marion, Sudhop Thomas
Bundesministerium für Gesundheit, Bonn, Deutschland.
Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Aug;60(8):804-811. doi: 10.1007/s00103-017-2574-1.
The entry into force of Regulation (EU) No. 536/2014 of the European Parliament, the Council of 16 April 2014 for clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC necessitated amendments to the national legislation on medicinal products. These changes mainly concern the sixth chapter of the German Medicinal Products Act (Arzneimittelgesetz, AMG) and the elimination of the GCP (good clinical practice) ordinance for clinical trials that will be covered by the regulation in the future. Sections 41a, 41b and 41c, which came into force in December 2016, regulate the registration procedure, the procedural rules and the business distribution plan according to which the responsibilities of the registered ethics committees for the authorisation procedures will be determined and cooperation with the federal higher authorities will be handled. All other amendments in the sixth chapter will not enter into force until the date of application of the regulation - presumably in the fourth quarter of 2018. In the future, Section 40a will regulate the general prerequisites - in particular the basic procedures for cooperation between the federal higher authority and the ethics committees - in addition to the provisions of the regulation. Section 40b governs special prerequisites for clinical trials and contains, in particular provisions for the informed consent in clinical trials with minors and incapacitated adults. Further changes concern, among other things, the transfer of previous regulations of the GCP ordinance into the AMG and adjustments regarding reporting obligations in the context of clinical trials in the AMG.
欧洲议会2014年4月16日关于人用药品临床试验的第536/2014号（欧盟）条例的生效，以及废止第2001/20/EC号指令，使得有必要对国家药品立法进行修订。这些变化主要涉及德国《药品法》（Arzneimittelgesetz，AMG）的第六章，以及废除未来将由该条例涵盖的临床试验的《药物临床试验质量管理规范》（GCP）条例。2016年12月生效的第41a、41b和41c条规定了注册程序、程序规则和业务分配计划，据此将确定注册伦理委员会在授权程序中的职责，并处理与联邦上级当局的合作事宜。第六章中的所有其他修订将在该条例的适用日期——大概是2018年第四季度——之前不会生效。未来，第40a条除了该条例的规定外，还将规定一般前提条件，特别是联邦上级当局与伦理委员会之间合作的基本程序。第40b条规定了临床试验的特殊前提条件，尤其包含了针对未成年人和无行为能力成年人的临床试验中知情同意的规定。其他进一步的变化包括，将GCP条例先前的规定转移至《药品法》，以及对《药品法》中临床试验背景下报告义务的调整。
