Global Pharmacovigilance, challenges, and future considerations: West globe and East globe

Abstract

Introduction: Pharmacovigilance (PV) plays a consequential role in the drug regulatory system and is a constantly evolving multifaceted field. In the process of carrying out its effective management, the PV system does undergo a lot of challenges on a global pitch. PV system is well developed in the western globe (United States,  United Kingdom,  Germany) while the east globe (e.g.: India) is still in the evolving stage.

Methods: Major discrepancies include different regulatory authorities for each nation with different forms for ADR reporting and also different timelines.

Results: To mention a few; there is a regulatory gap because of the continuously evolving regulations and business processes, it is difficult to comply with the diverse regulations effectively; gross underreporting in the east as compared to the west; increased concern about the safety and potential toxicity of traditional Chinese herbs in the east; self-medication; linguistic barrier, etc. Steps like harmonization of regulation by drafting guidelines that are uniform globally; leveraging digital technologies to optimize ADR reporting; meticulous and timely reporting; inclusion of PV in the curriculum etc. can be employed.

Conclusions: While PV has witnessed substantial development over the years, areas of discrepancies need to be identified to build a seamless PV system. Need for an effective revolutionary roadmap to tackle all the hindrances to fortify its harmonious functioning.