Pharma unphased

The critical step of navigating post-approval phase

Entering the post-approval phase marks a critical pivot for pharmaceutical companies, shifting their focus from the scientific aspects of drug development to the multifaceted challenges of commercialisation and ongoing regulatory compliance.

This stage is pivotal, determining the commercial success and impact of the drug on the market.

In the post-approval phase, pharmaceutical companies often explore broader uses for their drugs, such as new therapeutic indications, expanding the drug’s application to larger patient populations or commercialising in new markets. As the drug reaches more patients, developers gather data, refining safety profiles and optimising the drug’s risk-benefit balance.

Simultaneously, manufacturing processes must evolve to ensure production scales efficiently, providing consistent and timely access to high-quality medicines globally. This phase requires ongoing attention to supply chain dynamics, regulatory compliance and innovation in production methods to meet demand and sustain global availability of the drug.

Effective post-approval lifecycle management is essential for sustaining commercial success, particularly when life sciences organisations operate across multiple countries and markets. During this phase, companies must manage several critical regulatory tasks, such as registration renewals, labelling updates and marketing authorisation transfers and withdrawals.

Senior leaders must navigate a complex global regulatory framework, where harmonisation gaps and disparate health authority mandates can impact strategic market entries and product lifecycle extensions. This leads to differing requirements and classification systems that complicate compliance efforts, often necessitating tailored strategies for each region, further increasing complexity.

Unpredictable approval timelines across different countries and health authorities can delay key updates, while varied implementation periods for regulatory changes make global coordination difficult. Divergent decisions from health authorities can result in inconsistent outcomes for similar submissions, posing significant operational and strategic hurdles.

Given these challenges, a resilient post-approval lifecycle management is essential for success. There are three key steps for designing a solid regulatory strategy: planning, communicating and delivering.

Plan

The initial step is to develop a comprehensive and flexible plan, which serves as the cornerstone of a post-approval regulatory strategy. This strategic planning process should involve close collaboration with key stakeholders across the organisation. Early engagement is essential to understand their priorities and ensure all critical aspects are addressed. It’s crucial to be prepared for various potential scenarios and evaluate different perspectives throughout the planning process.

Communicate

A thorough communication strategy is essential for efficiently sharing information across the organisation. When updates occur, it’s important to ensure that both the changes and the communication surrounding them are clear, transparent and easily accessible. Providing supporting rationale for decisions is crucial in case challenges arise. Consistent follow-ups with stakeholders are necessary to keep them informed of progress and to collect feedback for potential adjustments.

Deliver

Clearly outline the essential roles and responsibilities for each team member to ensure accountability. Utilise key performance indicators and establish clear escalation pathways to monitor progress and address any issues promptly. Regular status updates are crucial to keep everyone aligned. Create a culture that promotes learning from mistakes and ensures that every regulatory action ultimately benefits patients and adds value to their care.

Tools

Incorporating cutting-edge technologies such as artificial intelligence and big data analytics into strategic frameworks is vital for keeping pace with regulatory demands. These tools empower teams to stay current with frequent regulatory updates and anticipate potential challenges by monitoring regulatory shifts and forecasting market developments.

By automating data collection and analysis, these technologies streamline decision-making, improve accuracy and reduce the administrative burden on regulatory teams. Developing systems to trace materials beyond the first tier of suppliers can ensure a clear understanding of the entire supply chain and minimise risks related to non-compliance and quality issues.

Final analysis

Successful navigation of the post-approval phase is a complex, ongoing process that demands careful planning, transparent communication and precise execution. Companies must collaborate across various departments to tackle challenges effectively and depend on regulatory experts to stay agile and responsive to regulatory changes.

Mastering the post-approval phase is essential for pharmaceutical executives. By synthesising regulatory expertise with business acumen, leaders can drive their organisations to not just navigate but thrive in the evolving healthcare landscape.

Marcela Miño is Senior Director of Regulatory Affairs and Drug Development Solutions at IQVIA