The European regulatory environment has become complex over the past years and for most of the people involved it became a challenge to maintain an overview. In addition the regulators seem to be on a fast track - the current speed of changes and adoptions make it difficult to follow.

As a result, increasingly questions are raised, such as "…where do I find this …", "…what are the current regulations for …", "…can I do it like this …", "… how can I evaluate if my application is complete and correct…", with a feeling of uncertainty coming up.

That was the time when the idea was born to compile a reference work for regulatory affairs the totally newly designed Guide to Drug Regulatory Affairs. It has always been the intention to assist in and facilitate daily operations. It shall guide through the jungle of requirements, legal provisions and multiple documents applied by regulatory professionals throughout Europe when preparing and maintaining applications for marketing authorisations as well as by all those involved in the advice and execution of functions in the European regulatory system. Collecting and sorting the host of information available, it was an interesting journey even for the authors themselves, refreshing their own knowledge.

The Guide to Regulatory Affairs is available as a print and an online version containing relevant internet links to the authorities and relevant documents. The online version was decided upon in order to be up-to-date with the regulations in a timely manner and to capture changes rapidly. Thus, print and online version continuously drifted apart regarding their contents, what is also reflected in the development of the structure of the 'Guide'.

The development of the European regulatory environment still continues. This does not only relate to the development of guidances to existing legal texts, but also to newly developed legal provisions, e.g. in the fields of advanced therapies, medicines for children, responses to challenges such as counterfeit medicinal products as well as legal texts as consequence of the 'Better Regulation Strategy' The authorities involved develop amendments to legal texts and guidances as well as new guidances to create an in-depth harmonisation. Consequently, the Guide to Drug Regulatory Affairs has developed in its online version just as well. This refers to the existing content as well as to an expansion of the themes. It is not a static project but subject to continuous development and improvement. Even though the Guide to Drug Regulatory Affairs continuously develops it does not claim to cover all aspects of regulatory issues.

Initially, the 'Guide' was divided into four major parts, A, B, C and D, meant to serve as an information platform providing

  • a comprehensive overview of the relevant EU legal and regulatory framework (Part A) including EU jurisdiction in the field of EU pharmaceutical legislation. A first compilation of the European regulatory environment laying down the beginning of the new European Marketing Authorisation System had been published in Germany by one of the co-authors, Brigitte Friese (then Brigitte Collatz), in a book entitled "Handbuch der EU-Zulassung" , of which Part A of the present work is the extended successor.
  • advice on how to compile an Investigational Medicinal Product Dossier (IMPD) and a dossier for marketing authorisation as well as maintaining the marketing authorisation of a medicinal product for human use (Part B).
  • the legal requirements for special drug products, e.g. orphan drugs, radiopharmaceuticals, blood and blood products, traditional herbal medicinal products and advanced technology medicinal products (Part C).
  • additional helpful information such as an extensive index of abbreviations, an index of terms and definitions (former Part D, now Part F).

Since the publication of the first print edition the structure of the 'Guide' has extended the following additional parts:

  • advice on how to compile dossiers regarding special drug products. This part will continuously develop. Actually it contains advice on dossiers for orphan medicinal products, advanced therapy medicinal products and paediatric medicines (Part D).
  • advice on how to handle and compile the eCTD (Part E).

The extension of Parts is accompanied by the joining of two notable and well-known authors:

  • Dr. Susanne Keitel, since October 2007 Director of the EDQM, European Directorate for the Quality of Medicines & Health-Care, being in charge of Part D.2 - Paediatric medicines


  • Sven Harmsen, Senior Consultant e-DRA Harmsen, being in charge of Part E - Electronic Technical Document (eCTD).

The authors hope that thus they will contribute to clarify the current European regulatory situation by identifying correlations, discovering rare application opportunities, helping to understand the different wordings among the regulatory documents and providing an orientation about the regulatory framework in Europe. It would be highly gratifying to the authors, if professionals will benefit from the Guide to Drug Regulatory Affairs, using it frequently and opening discussions. Every effort has been made to verify the accuracy and completeness of the information contained in this handbook.

As a consequence of the rapid development of EU pharmaceutical legislation, which is contrary to the static content of a paper version the publishing company decided to introduce the possibility of a "print-on-demand", which enables the customer to receive a print version on the basis of the most actual set of data contained in the online version.

Information in the 'Guide' must not be considered as legal advice. For the application of any information to specific situations and circumstances a competent counsel should be contacted. The views stated here are the views of the authors and not of her/his employers. The authors owe a depth of gratitude to the co-authors, who have supported the 'Guide project': Dr. Thomas A. Keller (Marketing Authorisation in Switzerland), Dr. Chris Oldenhof (Practical Aspects of Regulatory Compliance), Dr. Klaus Olejniczak and his colleagues, Dr. Gerd Bode, Dr. Peter Kasper, Dr. Eckhard von Keutz, Dr. Peter-Jürgen Kramer (Non-clinical Study Reports according to Module 4 CTD), Dr. Henrike Potthast (Bioavailability/Bioequivalence Studies), Dr. Joachim A. Schwarz (Clinical Study Reports according to Module 5 CTD), Prof. Dr. Barbara Sickmüller (Clinical trials in the EU, Pharmacovigilance) and her colleague, Dr. Jenny Müller, Dr. Susanne Keitel (Paediatric Medicines) and Dr. Sven Harmsen (eCTD).

Furthermore, the authors would like to extend their thanks to the publisher for the never ending patience during the phases of assembling and breaking off new grounds when preparing this 'Guide' as well as the continuous care and technical development of it.

Last but not least, the authors wish to express their deep gratefulness to their families. The project could not have been realised and may not continuously be persued without the support and understanding of the authors' spouses and children, who accepted that the realisation and continuation of such a project is extremely timeconsuming.

Brigitte Friese, Barbara Jentges, Usfeya A. Muazzam
March 2009

Edited by

Brigitte Friese
Barbara Jentges
Usfeya Muazzam

With special contri-
butions by
Sven Harmsen,
Susanne Keitel, Chris
Oldenhof, Klaus
Olejniczak, Henrike
Potthast, Joachim A.
Schwarz, and Barbara

Special contributions
related to Switzer-
land by
Dorothee Heer and
Thomas A. Keller

With a foreword by
Susanne Keitel