Structure and Content of an EU MAA
The requirements related to MAAs in the EU are set out in Volume 2 of the Rules Governing Medicinal Products in the European Union (Eudralex), which is known as the Notice to Applicants. The Notice to Applicants has no legal force and gives the coordinated perspective of the EU Member States on the most efficient method to meet the legal prerequisites of the relevant Directives.
Pre-CTD format – Old four-part format
Before the introduction of the CTD format, the Notice to Applicants described a dossier structure that comprised four specific sections:
- Part I: Administrative information, labelling, expert reports
- Part II: Chemical, Pharmaceutical, and Biological Data
- Part III: Pharmaco–Toxicological Data
- Part IV: Clinical Data
A more nitty-gritty portrayal of this construction is given in Attachment 1. This construction is as yet pertinent for old items, since there is no legitimate requirement to reformat information that was submitted before the appearance of the CTD.
CTD FORMAT
The principles behind the CTD are essentially no different from the previous MMA requirements. The applicant is obliged to provide sufficient data on the quality, safety, and efficacy of the proposed drug product to allow the regulatory authority to grant an MA.
A comparison of the contents pages of the CTD and this old MA submission structure is provided in the Notice to Applicants.
Figure 2 illustrates the differences between the old and CTD dossier structure – this is based on a graphic from the Notice to Applicants Volume 2B, with the previous MA sections added to it (the information in bold italics).
With one or two exceptions, the type of data required within the EU MA submission dossier was not changed.
The essential differences were that the ORDER, the EXTENT (in some areas) and the way in which the regulatory dossier is COLLATED changed.
EXPERT REPORTS, which were required in the old four-part format, were replaced by OVERVIEW documents that are more extensive in size and do not specifically require a signature by an expert.