Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Post-Approval Change Management Systems in the ICH Region with Focus on "Established Conditions" ***

Anja Wiechmann (Abschlußjahr: 2017)

Summary
Language: English
The management of post-approval changes on a global scale is complex, unpredictable and time consuming. Even in the ICH region different systems are existing. In the US, Japan and Europe are established different national procedures of handling post-approval changes. In 2015, the FDA drafted the guidance on established conditions to clarify which CMC changes need to be reported to the FDA. Established conditions are defined as the description of the product, manufacturing process, facilities and equipment and elements of the control strategy whereas certain CMC changes can be made solely under the pharmaceutical quality system (PQS) and its enablers, as described in the guidance for industry Q10. The PMDA has already a similar system since 2005 when the Pharmaceutical Affairs Law in Japan was revised, resulting in an enhancement of post-marketing measures. In Japan, different to the EU and US, module 1 of the NDA contains a summary of the most important elements of the application. The contents, that is described in that summary, is legally binding approved matters. On the contrary, the EU introduced the concept of the post-approval change management protocol in 2010, a two-step approach in the assessment of changes. Using a post-approval change management protocol might result in a lower categorization of changes than they would have been categorized under the traditional approach. Currently, the international council for harmonization of technical requirements for pharmaceuticals for human use is working on a harmonization of post-approval changes for marketed products within the ICH regions. This guideline, the ICH Q12, is not yet publicly available. Among others, the current working draft of the ICH Q12 guideline contains chapters on categorization of changes, established conditions and post-approval change management protocols. If the guidance come into force it could result in a paradigm shift in terms of the processing of post-approval changes on a global scale.
Pages 44, Annexes: pages: 6