Optimizing Strategies to Support Implementation of the Global Post-Approval Changes in the Product Life Cycle

Post-approval changes are necessary and inevitable throughout the life cycle of a drug product to implement new technology, maintain a state of control, and drive continuous improvement. Manufacturers that market drug products globally experience the greatest challenges and risks in their daily operations due to the regulatory complexity and delay in the implementation of the proposed post-approval change. The proposed post-approval changes are meant to reduce patient risk, improve compliance, or enhance the manufacturing process or test methods, however, the jurisdictional regulatory complexity in countries’ health agencies slows down continual improvement and innovation. This, in turn, can cause drug shortages and current good manufacturing practices (cGMP) compliance issues.

Because drug products are highly regulated in every country, any change proposed to a registered drug product must be assessed based on the country’s regulations. If the proposed change is assessed as a major or moderate level of change classification, then the proposed change must be approved by the individual countries’ regulatory agencies before implementation. Individual post-approval changes usually take years for global approval because of the country’s regulatory complexity.

This presentation will provide science-based and risk-based strategies and approaches to optimize the implementation of post-approval changes. It is recommended that the industry work together to identify ways to demonstrate to regulators that product and process knowledge and pharmaceutical quality systems are strong enough that the manufacturers should be allowed to manage some post-approval changes themselves. An aligned and standardized industry position on the effective management of post-approval changes must be activated to accelerate the implementation of the post-approval changes.