All the major pharmaceutical companies have Global Labeling Process policy is in place in order to ensure that product information documents (Labels – Core/National) are in place with scientifically sound data on safety and efficacy, internationally consistent with local laws, and compliant with applicable regulatory requirements. Although, defined and strategic labeling concepts are followed while creation/update/amendment of labels but still significant audit findings, compliance issues, content inconsistency market to market, increased cost and need for new IT solutions for label management are matter of concern and point of discussion. Despite of pragmatic approaches and efforts for effective content management there are challenges persisting and they need to be addressed. The solution must provide complaint Labeling Management in terms of safety and efficacy information reaching to end users (prescriber/patient)and IT solutions to make cost effective. Both together will give breathing space to pharma players since regulatory maintenance activities are obligations to ensure patient safety and in this current changing environment where world is affected by pandemics and inflation, the Industry and Health Authorities need to adopt and accept new ideas and solutions.
The above stated concerns should be looked upon in details and as they involve effort, cost, audit findings (compliance) and labeling management system need attention and correction in following areas.
Global Standards and Harmonization:
Marketing Authorization Holders (MAHs) is responsible to create/update/maintain product information documents (Label) based on relevant national authority requirements and health authority recommendations in the regulatory market. The prominent markets USA, EUROPE, APAC, MENA etc. have their own recommendations per their governing Health Authorities.
All the regulations across globe have paramount objective is to ensure patient safety and core safety information is directed to captured irrespective of market. The global arena must look for common template so that local labels can be easily adopted out of core label. European Commission, CIOMS Working Group,Unites States Code of Federal Regulations, United States Food & Drug Administration, MHRA, Health Canada, TGA & Japan, each of them have recommendations on capturing core safety information sections (ADR, CI, W&P, Pregnancy, DDI etc.) and at detailed level there are minor to major differences which creates data inconsistency. These end up filing safety variations and differences in local labels. A unified consistent guideline will decrease Industry’s burden on maintaining different labels for each market and also will decrease waiting period HA for approval on safety variations before the label become effective in market.
Labeling Content Management:
The Core data Sheet data evolves from IB, DCDS labeling format and further local labels are derived following CDS sections. Core Safety information from a product’s CDS is considered for local label’s content and all this CSI content come out by referring multiple documents and alignment with these other documents is must in order to avert any data inconsistency. The documents or reports are as such Safety Profiling Plan, Investigator Brochure, Risk Management Plan, Results from signal detection activities, Annual Safety Report, Summary of Pre-Clinical Safety, Summary of Clinical Safety, Clinical Overview, Periodic Safety Update Report, Pre-clinical Study Analysis, Pre-clinical Overview, Epidemiologic analyses, Responses to Health Authority inquiries.
Analyzing and referring these many documents individually is time consuming and are always with possibility of error to miss significant data. Thus, process improvement is needed in order to access and assimilate these in a manner that content for sections of CDS can be consistent and represent safety and efficacy information in most correct manner to ensure patient/ prescriber purpose.
Labeling Management System with Automation, System Integration & AI inputs:
Labeling content from different sources and one format to another format takes lots of effort. Once the content finalized, local labels goes through HA approval and HA communications. An approved label gets implemented at market in the form of printed artwork. Throughout the journey multiple documents are created e.g. label comparison sheets, summary of deviations, label iterations, communications, artworks and goes through in-house approval with many functional line functions (Regulatory, Safety, Clinical, Pre-Clinical, Legal, Marketing). Overall 12 to 14 weeks are consumed in a label creation to implementation process. The prominent reasons are sequential process steps and multiple databases or lack of integration of data management system. Labeling content reproducibility is key to save time and get templates autopopulated and automation at operational level is very much needed to turn sequential process steps into parallel approach.
MakroCare has developed in-house tool which addresses most of the issues from Labeling Content Management standpoint. The in-house LABELai enables achieving End-to-End regulatory labeling goals. The integrated tool allows Label Lifecycle Management (LLM) or Label Operations or both to enhance productivity and efficiency. Content part ensures top-down approach linking content and operations seamlessly. LABELai utilizes Artificial Intelligence and NLP business rules internally coupled with local country requirements (Reg Intel built-in) and all of this delivered in a cloud platform to reduce IT burden drastically. In turn, all label aspects managed automatically without manual efforts. With the use of an automated tool, labeling teams can reduce time, costs and non-compliance challenges.