Pharmacovigilance Adverse Event Reporting in Emerging Market: Procurement Challenges and Sourcing Best Practices

In the recent year?s rapid stimulation of NCEs (New Chemical Entities) and high tech Pharma products in the market has revealed the challenges for capturing & monitoring Adverse Drug Reactions (ADRs) on a global scale & specifically for emerging countries like India who have a large & diversified population base. Also global regulatory authorizes like FDA and EMEA are intensifying safety regulations, for enhancing the adoption rates of pharmacovigilance systems by pharmaceutical companies. The present systems for Local level Adverse Event reporting in emerging countries like India & China are still at a nascent stage and currently there is no robust framework or vendor base to meet the local volume requirement from large Pharma companies for AE data capturing and reporting. With the MCs (Medical communication companies) having core competencies in their resources to report the Adverse Event (i.e. AE data) both at local and regional level, are expected to play a crucial role in collection and handling AE data.