Previously, the terms clinical study and clinical trial were used synonymously. In order to market a medicine, a submission (an application) must be made to the relevant regulatory authority, for example the European Medicines Agency (EMA).
Submissions provide comprehensive information about the medicine, its formulation, the trials it has undergone, its intended use, and its risks and benefits.submission of the dossier for the Marketing Authorisation Application (MAA), and other activities after the MA is granted, for instance applying for a change to the marketing authorisation (a variation).
The Marketing Authorisation Holder can then legally begin to market the medicine in all EEA (European Economic Area) countries (EU EFTA States (Iceland, Liechtenstein, and Norway).
National Competent’ Authorities (NCAs) are responsible for evaluation of marketing authorisation applications and granting MAs for medicines that fall outside the scope of the centralised procedure.
Figure 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.
The format of the CTD has been developed by the International Council for Harmonisation [ICH] The International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) produces harmonised guidelines for global pharmaceutical development, and their regulation.Regulatory Affairs (RA) departments are (or should be) an integral part of all steps throughout the life-cycle of the medicinal product.Regulatory Affairs are responsible in particular for the applications that must be submitted before every Clinical trial A clinical trial is a clinical study in which participants are assigned according to a pre-defined therapeutic strategy or plan (protocol) to receive a health-related intervention, such as a medicine, in order to investigate its effects on health outcomes, usually compared to another (or sometimes no) treatment.A single application is submitted to the EMA for evaluation by the Agency’s Scientific committees.If the assessment is positive, a single marketing authorisation is issued by the European Commission.Clinical trials are conducted only after a regulatory authority approval and ethics committee review.Clinical trials are often characterised in Phases from I (first-in-human), II (exploratory), III (confirmatory) to IV (post approval).International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).The CTD is to be used for all types of MAAs in the EU irrespective of the procedure (Centralised procedure [CP]The centralised procedure is a process for obtaining marketing authorisation for a medicine in the EU.These procedures result in national MAs for each member state involved.Regulatory affairs is a relatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including human medicines, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.