On comparing progress in other areas of regulatory information management, labeling is standing apart as a jumble of systems and processes that lacks connection or consistency with core systems. The rising need for manual checks can invite risks, delays, and costs, specifically between territories.
FREMONT, CA: With global manufacturing being a burden in life sciences, a significant part of the problem is how content independencies are managed. It is essential to find that how a change along the safety-regulatory-manufacturing-supply chain will impact label content from the global core datasheet to the patient-facing product data in each country. The tracking of label status still happens in Excel spreadsheets or home-grown systems. The content is updated on a country-by-country basis by leveraging dedicated labeling tools which are seldom connected to companies’ registration and submission planning and management tools, obstructing a clear line of sight, and management capabilities, throughout all labeling activities.
The primary challenge is a company’s inability to map country/label interdependencies efficiently so that the changes can be kept at bay promptly and reliably wherever the new requirements are applied. Submissions are bundled at the country level so that they can comply with local regulations or the company’s internal conditions and strategies. Additionally, labeling changes can be initiated at different points in the drug environment. The difference in the profile of a drug benefit will attract revised labeling requirements from the global core of the organization. Local regulatory changes, which are referred to a country can drive a need for amendments both up and down the chain. Hence the solutions cannot be one-directional in its treatment of cascading changes.
Portals are not a Panacea
An approach adopted by the life sciences companies to manage the labeling changes is the creation of data-exchange portals between global and local functions to ensure that different points in the international labeling management chain can combine and report back on needs related progress. But even this process relies too heavily on manual updates and process repetition.
Right end-to-end label and product tracking and change management primarily require to encompass artwork updates and follow into the warehouse and beyond that as well. Hence the more innovative the firms become more they are subjected to intensify regulatory criteria and be more meticulous and efficient in their monitoring and process controls.