This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe.

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A sponsor wishing to conduct clinical studies with an investigational drug in the European Union must seek and gain approval before each phase of clinical development. This entails submitting a Clinical Trial Authorisation (CTA) application to the regulatory Competent Authority of each Member State (MS) in which the clinical trial is to be conducted.

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Orphan drugs are those for relatively rare indications. Special procedures and incentives apply to their registration, to encourage pharmaceutical companies to develop them. This module provides information necessary to enable the preparation of applications for orphan drug status in the EU and USA.

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GMP is that part of Quality Assurance which ensures that pharmaceutical products are consistently manufactured to the quality standards appropriate to their intended use and as required by a marketing authorisation or product specification. Manufacturers' compliance with GMP legislation is a requirement of approval of regulatory submissions.

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The CP is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA). In the CP, one successful application leads to a licence being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products.

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The Mutual Recognition Procedure is one of three routes available to applicants to gain multinational Marketing Authorisation within the European Economic Area (EEA). A national licence is converted to harmonised licences issued in a number of other member states chosen by the applicant.

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The CTD is the mandatory format for regulatory submissions in the European Union, Japan and Australia and strongly recommended in the USA and Canada. It is accepted widely elsewhere. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.

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The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of registration dossiers. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product.

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Changes to the terms of marketing authorisations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. . .

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