Module 1: Regional administrative information The CTD modules are represented here as a pyramid split into three levels.įigure 2: The Common Technical Document triangle. They also produce the summaries that are included in Module 2.ĭiagrammatic representation of the common technical document ( CTD) modules. Regulatory Affairs professionals ensure that the documentation submitted is in-line with all relevant regulations, directives, and guidelines. The majority of the documentation relating to the quality, safety, and efficacy of the medicine are in Modules 3 to 5. Modules 2 to 5 of the CTD are common for all regions, while Module 1 is specific to each region and is not considered part of the CTD. Module 1: Regional administrative information.There are five distinct modules in the CTD. The CTD format is applicable for all types of products (new chemical entities, radiopharmaceuticals, vaccines, herbals, etc.).
The CTD is to be used for all types of MAAs in the EU irrespective of the procedure ( Centralised Procedure CP, Mutual Recognition Procedure MRP, Decentralised Procedure DCP or National Procedure NP) or the type of application (stand alone, generics, etc.). The format of the CTD has been developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH). What elements does a dossier include?įigure 2 shows the elements that make up the Common Technical Document ( CTD), the dossier that is submitted to the regulatory authorities as a Marketing Authorisation Application ( MAA) in Canada, Europe, Japan, Switzerland, the United States, and others.
#A dossier definition full#
This kind of medicine would require a full dossier to be submitted, in which all elements of documentation for the medicine must be included. Figure 1 illustrates the development process for a new, innovative medicine. A bibliographic application – based on existing scientific literature.Īpplications require the submission of a dossier of documentation to the relevant authorities.An abridged application (reduced application).A full application – see Common Technical Document triangle ( CTD) below.The pharmaceutical company must decide at an early stage of development what type of application to submit for the marketing authorisation e.g.: Submissions for Marketing Authorisation (MA) It takes well over 10 years of careful planning and research for a medicine to go from molecule to a marketable treatment.
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