Pharmacovigilance in Asia

Abstract

An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders more importantly by the regulatory authorities. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Proactive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety in Asia. It has been a constant challenge to standardize pharmacovigilance in Asia, in the context of clinical trials and post-marketing pharmacovigilance due to varied geaographical, cultural and medical practices in these regioon. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in Asian countries, though several attempts have been taken. However, with more clinical trials and clinical research activity being conducted in the Asian continent, there is an immense need to understand and implement pharmacovigilance. For this to happen, the mind set of people working in regulatory agencies, the Pharmaceutical companies, prescribers and patients/consumers need to change.

Keywords: China; India; Japan; Korea; pharmacovigilance.

Figure 1

Structure of SFDA, China

Figure 2

Timelines for reporting ADRs

Figure 3

Timelines for periodic safety update reports (PSURs)

Figure 4

Governance structure

Figure 5

Targets for the PV program in India

Figure 6

Program communications

Figure 7

Operating system of RPVC