[Harmonisation of the Marketing Authorisation Application dossier: Perspectives due to harmonised re
June 29th, 2008 | by admin |[Harmonisation of the Marketing Authorisation Application dossier: Perspectives due to harmonised requirements. Assessing Rules and the Common Technical Document.]
Assessing Rules for Marketing Authorisation Applications and the Common Technical Document provide the framework regarding data-related requirements and regarding the structural requirements of marketing authorisation application dossiers, similar to the structural levels and rooms of buildings on the one hand and their interior equipment on the other hand. Since the 1970s requirements about how to submit application dossiers and how to assess them have become increasingly harmonised, aiming for the use of a single format and identical rules for assessment. In regard of the format, harmonisation has been achieved beyond Europe by implementing the mandatory use of CTD in the three main regions of interests of the pharmaceutical industry, Japan, the United States of America and Europe. The assessment rules have been extensively harmonised throughout Europe in a way that the same rules apply to the marketing authorisation applications submitted in Germany as well as in other Member States. Different interpretations of the guidance documents, different understanding of the provided data or divergent conclusions drawn up may still occur. All stakeholders within the European network of Drug Regulatory Affairs will act on the level floor of the European and - apart from some exceptions - also nationally imple- mented legislation. This will not only serve the internationally acting pharmaceutical companies\’ interests but also consumer interests in obtaining consistent information on drug products based on transparent rules safeguarding the necessary pharmaceutical quality, efficacy and safety with respect to an adequate risk-benefit relationship.
Menges K.
Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, BRD, k.menges@bfarm.de.