Masterarbeit

How to update a CEP? An analysis of the regulatory activities in a middle-sized pharmaceutical company, taking account of the new Q&A of the EMA ***

Patricia Westendorf (2018)

Summary
To obtain a marketing authorisation for a pharmaceutical product granted by a competent authority and to maintain it during the whole lifecycle in the European Union, it is necessary to describe and to prove the safety, efficacy and quality of the product. A Certificate of Suitability (CEP) issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM), is one possibility to describe the pharmaceutical quality for an Active Pharmaceutical Ingredient within the Common Technical Document (CTD) of the finished product. CEPs can be allocated for active substances which are monographed within the European Pharmacopeia (Ph.Eur.). The CEP procedure is a single centralised procedure excluding duplication of work for different competent authorities and avoids any divergences in assessment.
In November 2016, the European Medicines Agency (EMA) published a new Question & Answer (Q&A) concerning CEP update and their regulatory handling - "How should I submit an updated Certificate of Suitability (CEP) (Classification Guideline B.III.1)?".
Before this Q&A the CEP users had to register each revision of the CEP to ensure the contemporaneity of the CTDs of their finished products. Nowadays, according to the Q&A only the CEP revisions which were used during the manufacturing process of the finished product have to be registered via variation.
This thesis covers the challenges and opportunities of using a CEP with particular consideration of the Q&A from the perspective of the regulatory department of a middle-sized pharmaceutical company, medac Gesellschaft für klinische Spezialpräparate mbH. It describes the diversity and heterogeneity of variations, the necessary internal process adaptions and cost effectiveness concerning CEPs variations before and after the publication of the Q&A.
Pages: 62