Contract Pharma: What are the current challenges with labeling?
 
Rama Mohan Rao Chikkam: Pharmaceutical labeling faces multiple challenges in the current landscape, most of which fall under the categories of regulatory or operational obstacles. 
 
When it comes to regulatory challenges, differing requirements across regulatory agencies in various regions, including EMA, USFDA, PMDA, and Health Canada, pose complexities. Navigating and complying with these unique regulations demands significant effort and time. Localization and translation also present challenges in global markets. Accurate translation and adaptation of labeling content to different languages and cultural contexts is crucial. Maintaining consistency while adhering to local language and regulatory requirements requires meticulous coordination and ample resources.
 
Moreover, regulatory guidelines frequently evolve to enhance patient safety, streamline information, and accommodate emerging technologies. Keeping up with these updates requires continuous adaptation of labeling practices to ensure compliance. Change management for labels themselves also poses operational complexities. With pharmaceutical products undergoing lifecycle changes such as formulation updates, new indications, or packaging modifications, managing labeling and artwork changes across various product presentations becomes challenging. 
 
Ensuring proper communication internally and externally is vital for seamless implementation. Regulatory agencies emphasize clear and concise communication of risks and benefits to healthcare professionals and patients. Meeting these requirements necessitates careful consideration of language, formatting, and ensuring comprehensibility. 
 
Pharmaceutical labeling also faces a range of operational challenges, including data management. The labeling process involves handling vast amounts of data and information, including product ingredients, indications, dosages, warnings, implementation details, and tracking. Ensuring the accuracy, consistency, and accessibility of this data throughout the labeling process can be particularly challenging for companies with extensive product portfolios. It is also essential to maintain proper version control of labeling and artwork to prevent errors, omissions, or the use of outdated information. Managing revisions, tracking changes, and maintaining comprehensive documentation throughout the product lifecycle can be complex, especially when multiple versions of labels are in circulation.
 
Effective collaboration and communication among different stakeholders involved in labeling is vital. This includes regulatory affairs, quality assurance, medical affairs, and marketing teams. Coordinating these teams, who often operate across multiple locations, can be challenging, especially when faced with tight timelines and frequent labeling updates.
 
Supply chain management is also a significant challenge in labeling. Proper management of the labeling and artwork supply chain, including printing, packaging, and distribution, is crucial. This involves ensuring accurate inventory management, timely availability of labels and packaging materials, and effective coordination with external vendors or contract manufacturers.
 
Contract Pharma: What does development and submission of labels and regulatory filings entail?
 
Rama Mohan Rao Chikkam: The development and submission of labels and regulatory filings encompass several crucial steps. First, the core label is created, which includes essential information like product name, active ingredients, indications, warnings, dosage instructions, and storage conditions. This serves as the foundation for all label variations.
 
To comply with different markets, labels are adapted to meet local requirements. This involves translating the core label and tailoring it to fit the language, culture, and regulatory framework of each market. Localized labels must adhere to specific regulatory standards and guidelines, such as including local contact information, symbols, or required warnings.
 
Once the core label and adaptations are complete, electronic labels are prepared for submission. These labels, along with the necessary documentation, are then submitted to regulatory authorities for review and approval. Each regulatory agency has its own submission requirements and procedures that must be followed.
 
The submitted labels undergo a thorough review by the regulatory agencies to ensure compliance with their regulations. Feedback may be provided, additional information may be requested, or modifications may be required to meet the agency’s standards.
 
After approval, it is important to maintain the accuracy and compliance of the labels. Any updates, changes, or variations to the label may require additional submissions or notifications to the regulatory agencies.
 
The development and submission of labels and regulatory filings involves careful attention to detail, adherence to regulatory requirements, and effective communication with regulatory authorities throughout the process.
 
Contract Pharma: What services are needed to support label regulatory compliance?
 
Rama Mohan Rao Chikkam: Comprehensive support is needed to ensure label regulatory compliance for pharmaceutical companies. 
 
It’s important to provide regulatory intelligence by keeping track of the evolving regulations and guidelines related to pharmaceutical labeling globally, regionally, and nationally. IQVIA provides pharmaceutical teams with up-to-date information, ensuring they stay informed about the latest requirements.
 
Experts can support development and reviews of pharmaceutical labels to ensure compliance with regulatory standards. IQVIA works closely with pharmaceutical customers to create labels that accurately reflect product information, adhere to relevant regulations, and meet the specific requirements of different regulatory bodies.
 
Experts can also conduct thorough assessments of existing labeling materials and processes to identify opportunities to optimize labeling compliance. IQVIA can identify any gaps or areas of non-compliance and provide valuable insights and recommendations to help achieve and maintain labeling compliance.

Labeling teams can also assist in preparing and submitting regulatory filings for labeling compliance by compiling the necessary documentation, such as product monographs, safety data, clinical overviews, and justification documents, and ensuring they meet the requirements of regulatory authorities.
 
Electronic labeling solutions, including the creation of Structured Product Labeling (SPL) files and Structured Product Monographs (SPMs), supports generating and managing electronic labels, as well as facilitating efficient electronic submission processes.
 
IQVIA provides support for pharmacovigilance activities related to labeling compliance through the identification and management of labeling-related adverse events and safety concerns. This helps pharmaceutical compliance teams fulfill obligations in reporting and updating labeling information as needed.
 

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Rama Mohan Rao is IQVIA’s Senior Director of Global Regulatory Affairs-India (GRA-India) focusing on leading the GRA-India division for Global Regulatory Services and Technology. Rama Mohan Rao acts as the business domain expert between Regulatory Affairs and IT divisions for implementing RA Life Science IT tools and driving change for global operating models by connecting technology with pharma’s strategic priorities.