Updated on 6 September 2012
Pharmacovigilance - Several conflicting trends have emerged in Asia (Photo:Bigstock)
For many Asian pharmaceutical companies, pharmacovigilance is a critical component of any drug development program. As product safety continues to receive a high level of emphasis from regulators, developers and the public alike, the need to effectively meet regulatory requirements, manage risk and process safety reports remains a key point in pharmaceutical development in Asia.
However, a number of conflicting trends have emerged regarding pharmacovigilance strategy and operations among Asian firms in the recent years. Regulatory bodies across the region are intensifying safety regulations even as they are working to reduce approval times and accommodate the explosion of activities in the region.
As a result, companies are receiving a growing numbers of safety reports despite a trend towards decreasing staff in their pharmacovigilance operations. At the same time, many companies opt to retain in-house pharmacovigilance staff, while a wide range of other pharmaceutical operations are increasingly becoming candidates for outsourcing and off-shoring. Together, these and other trends result in increased costs and slower processing times of pharmacovigilance operations.
Much like their counterparts in other parts of the world, many Asian pharmaceutical executives view pharmacovigilance primarily through the lens of cost, even as they recognize the value of carefully managing a product's safety profile. This perspective leaves companies struggling to achieve a balance between high productivity, short cycle-times and high quality.
For other components of the development process, the solution may well be found in outsourcing. Yet, due to the critical nature of analyzing and processing safety data, many companies are reluctant to turn to outsourcing as a solution.