What does the "Guide" want? This 'guide' is the first comprehensive work that gives an overview of legal and regulatory aspects when applying for drug approvals in Europe and Switzerland. He provides exhaustive and valuable advice on creating a dossier in CTD format (Modules 1 - 5 CTD). Why was the "Guide" developed? The "Guide" was developed to penetrate the "regulatory jungle" and the Facilitate work in the area of ​​approval and make it more efficient. The 'Guide' will be available as a print version as well as an updated online version and thus as a multimedia platform to meet the different needs of many users. The "Guide" is divided into four main parts Part A: This section provides detailed information on the various approval procedures as well as relevant laws and requirements that must be observed when submitting an application for authorization. In addition, references are made to judgments of European courts. Part B: This section gives practical advice on the preparation of an application for authorization, as well as on the accompanying documents demonstrating the quality, safety and efficacy. In addition, aspects of maintaining market authorization are discussed: amendments, extended approval and renewal of a marketing authorization. Other topics include regulatory compliance and requirements for Investigational Medicinal Product Dossiers (IMPDs).