The need for balance

To meet the requirements of a demanding and changing regulatory and development landscape, Asian pharmaceutical firms must view pharmacovigilance operations as more of a strategic opportunity and less of a mandated cost center. To accomplish this transition and effectively position themselves for the future, developers must identify a pathway that addresses both quality and productivity, while also minimizing risk, adapting to fluctuations in demand and creating strategic value by carefully managing the safety profile of products.

Of course, the challenges inherent in strategically positioning pharmacovigilance to create value are many. For one, language barriers and complex regulatory environments make Asia one of the most challenging markets for developers to achieve regulatory compliance. Within such a complex environment, managing data collection processes involving multiple non-clinical sites with non-physician medical reviewers proving to be a significant logistical and data collection challenge.

Further, lesser rates of electronic data capture and computer-based analysis than elsewhere around the globe force many companies to choose between devoting scarce resources away from strategic interactions with health authorities and developing innovative treatments and more towards day-to-day document and data management.

Perhaps most important need for Asian developers is to ensure the highest levels of quality around drug safety reporting and risk management, to both meet regulatory guidelines and to effectively shepherd drug development and commercialization. For example, many companies struggle with the ongoing potential for high levels of non-compliance risk from increasing numbers of case reports and changes in regulatory requirements. Developing timely and effective medical assessments, signal detection, medical review, case monitoring and other vital processes and analysis are critical components of successful pharmacovigilance.