Obtaining drug marketing authorisation in the EU is a complex process, necessitating a broad range of knowledge in various areas of specialisation that requires Regulatory Affairs Managers to be a pharmacist, lawyer, quality manager and project manager in one.
You can use various sources to draw up marketing authorisation applications, but if you are not sure what exactly you are looking for, it is easy to get lost in the sheer abundance of information and lose valuable time. In contrast, the Guide to Drug Regulatory Affairs eases you through the necessary procedures, comments on EU and EMEA documents and helps you draw up your application.
This reliable source of information is available in a print edition as well as an online version for access to over 1,000 regulatory documents. Written and compiled by respected experts from government agencies, institutions and companies for both newcomers and professionals in the regulatory scene, the Guide is the first-ever reference work on the organisational, legal and CTD aspects of applying for marketing authorisation.
The features of the online Guide
The contents of the online version are regularly updated and amended by the authors, plus our email service will alert you to developments, doing away with the need to make time-consuming searches in various sources to find the same information.
The Guide provides access to EMEA guidelines as well as documents issued by EudraLex, the EU Commission, EDQM, ICH, etc., meaning you do not need to switch media or leave the CTD format.
Links are checked weekly for enhanced search efficiency, plus the portal provides over 210 bibliographical references to show you where to find important legal decisions in official publications. Links are also offered to over 50 addresses at EU and EFTA institutions.
Fit for the future
The Guide will ease you into using eCTD – the electronic means of making marketing authorisation applications – with the help of links that take you to the right application forms. All you need to do is download the forms, fill them out and save them online in CTD format (Modules 1-5).