Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory environment for defined post-approval CMC Quality Control method changes of Biologics worldwide and implications for a suitable MAH change management

Dr. Christopher Weber (Abschlußjahr: 2018)

Summary
Language: English
The regulatory classification of the CMC Biotech QC method post-approval changes examined in this thesis varies significantly among the examined countries from no regulatory action to up to 18 months approval time. Furthermore, within some countries there was no difference between the approval times of the Cases I-III. These facts indicate a lack of harmonization among countries and a lack of differentiation and risk based classification of changes within many countries. Furthermore country specific data/document requirements and country dependencies complicate the situation.
Every pharmaceutical company must find a suitable regulatory and implementation strategy for every post-approval CMC biotech QC method change to avoid out-of-stock and out-of-compliance situations. Companies should therefore in their processes make use of the whole variety of possible strategies including immediate implementation, implementation after worldwide approval, parallel QC method testing, simultaneous worldwide submission date and/or (as far as possible) simultaneous worldwide target approval date depending on the specific regulatory situation, the urgency and the nature of the change.
Colombia, Chile and Peru should harmonize their pharmaceutical regulations with a future final WHO guideline for biotech products (currently draft) rather than within the Pacific Alliance which is more a long-term project. Russia, Belarus, Georgia, Armenia, Kazakhstan and Kyrgyzstan should be supported to implement the new EAEU variation system. The ICH countries USA; EU, UK, Japan, Canada, Korea, Brazil, and China (and in the future possibly Mexico) should first harmonize their regulatory systems based on Q12 (currently draft). Medium-term the pharmaceutical industry should support to create a Q12 descendant which should adopt concrete elements of the WHO biotech draft guideline along with other more concrete guidance. The implementation of the EU-based post-approval change guideline in Turkey in the near future should help to improve the Turkish change assessment processes.
Pages: 71