| dc.description.abstract | Regulatory requirements for post-approval changes vary for different countries around
the world. It is a challenging and costly process for pharmaceutical companies to
manage changes to the approved regulatory dossier over the lifecycle of the product
when it is registered in many countries. In practice the process can be complex,
unpredictable and time consuming because of regional differences and frequent
changes in regulatory procedures, requirements and timelines. The global regulatory
requirements for the submission of a post-approval change, specifically a change in
manufacturing site, were reviewed for six jurisdictions for this study. These include
United States of America (US), Europe (EU), South Africa, Brazil, Russia and China. The
study centred on the differences in the documentation required when submitting a
post-approval change for a change in manufacturing site in these countries. The study
compared and contrasted the differences and similarities between the jurisdictions. An
analysis of the challenges for implementation of the change was performed. The study
also examined what resources a company may need in order to meet the
requirements. Some notable similarities but also many differences in the post-approval
submission requirements between the countries were identified. Some of the
similarities included classification of the type of variation, the submission application
process, and the requirement to provide supportive stability data and updates to the
common technical dossier (CTD). Differences highlighted were the types of application
forms required, the amount of stability data required to support the change and the
time lines for review of post-approval changes in each jurisdiction. The challenge for
pharmaceutical companies arises in the effective management of these differences.
Investment in a robust regulatory change management team is an essential resource
requirement for pharmaceutical companies. Adoption of a QbD approach and careful
consideration of the global requirements during the product development phase could
potentially be of use in strategic planning within a company in order to ensure
continued product access globally. | |
