An analysis of the quality issues that were raised on the chemistry, manufacturing and controls of drug substance and drug product during the European regulatory decentralised procedures where Malta was a concerned member state

Abstract

The decentralised procedure for medicinal products (DCP) is one of the regulatory procedures for the registration of new medicines in Europe. This procedure has been in use since November 2005, when Directive 2001183/EC (as amended by Directive 2004/27/EC) became effective. As part of this registration process, a lead (or reference member state RMS) prepares a preliminary assessment report which is circulated at Day 70 of the procedure, to the applicant and the other member states (or concerned member states - CMS) involved in the procedure. Although the effects that the chemistry, manufacturing and controls (CMC) have on specific areas in the development of a medicinal product are well known, only a few publications have addressed these issues as a whole and none have based their studies on the DCP. The aim of the present research was to identify the CMC (or quality) issues that were raised by the RMS in the DCP and to determine any trends in the type of issues that were raised. The objective was thus to propose possible solutions or improvements towards making the medicines registration process within the DCP a more efficient one, for the benefit of patients throughout Europe. A database of questions was derived from the Day 70 RMS assessment report of one hundred and fifty (150) DCP in which Malta was a CMS; the majority of the applications reviewed were for generic drugs (72%). This database was designed in such a way so as to have the questions identified in the manner as described in the Volume 2B of the EU Notice to Applicants guide. The function of this guide is to aid a prospective applicant to prepare a medicines registration dossier for a marketing authorization application (MAA). The information in the database could therefore be categorized according to a defined convention, providing an appropriate starting point for the discussion of the findings. Due to the qualitative nature of the data generated, it was determined that a quantitative research method was not suitable and a qualitative method would be more appropriate.