After a medicinal product has obtained Marketing Authority (MA,) it is authorized for commercial use. However, maintenance obligations must continue to be met in all regulated areas.
To retain Marketing Authorization, the MA holder must continually:
- Update work to ensure the approved dossier is valid
- Address safety surveillance issues by having pharmacovigilance systems in place
- Implement and maintain quality management / assurance systems to deal with developments such as changes in the manufacturing of the product and relevant changes in the company’s settings
- Respond to renewal requirements, as necessary
Challenges that accompany large product portfolios, differing global markets, evolving regulatory landscapes, and stakeholder expectations can further increase the complexity, unpredictability and intensity of the Post-approval Phase.
Changes in development and regulations require continuous updates to systems, documents and agreements. Consequently, time and resources may be strained, causing new product development to suffer.