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Updated: May 4, 2026

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Pharmacovigilance in Asia.

Pipasha Biswas1

  • 1Symogen Limited, Bourne End, United Kingdom ; Special Interest Network Consultation Committee for Drug Safety and Pharmacovigilance, Faculty of Pharmaceutical Medicine, Royal College of Physicians, London, UK.

Journal of Pharmacology & Pharmacotherapeutics
|December 19, 2013
PubMed
Summary
This summary is machine-generated.

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Drug safety concerns are rising, necessitating proactive pharmacovigilance (PV) for effective risk detection and management. Standardizing PV in Asia requires a shift in mindset across all stakeholders.

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Regulatory Science
  • Global Health

Background:

  • Increased drug safety concerns and high-profile withdrawals necessitate enhanced regulatory oversight.
  • Rising Adverse Drug Reactions (ADRs) reporting increases data management complexity and requires specialized expertise.
  • Proactive pharmacovigilance (PV) throughout the product lifecycle is crucial for modern drug safety.

Purpose of the Study:

  • To highlight the growing importance of pharmacovigilance in response to drug safety issues.
  • To address the challenges in standardizing pharmacovigilance practices across diverse Asian regions.
  • To emphasize the need for a proactive approach to pharmacovigilance in Asia.

Main Methods:

  • Review of current trends in drug safety and pharmacovigilance.
Keywords:
ChinaIndiaJapanKoreapharmacovigilance

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  • Analysis of challenges in implementing standardized pharmacovigilance in Asia.
  • Discussion of the necessity for proactive pharmacovigilance strategies.

    • Main Results:

    • Significant advancements in pharmacovigilance have occurred in Western countries, with less progress in Asia.
    • Varied geographical, cultural, and medical practices pose challenges to standardizing pharmacovigilance in Asia.
    • Increased clinical research in Asia underscores the urgent need for robust pharmacovigilance implementation.

    Conclusions:

    • Proactive pharmacovigilance is essential for the future of drug safety in Asia.
    • Standardization of pharmacovigilance in Asia is hindered by regional diversity.
    • A change in mindset among regulatory agencies, pharmaceutical companies, prescribers, and consumers is vital for effective pharmacovigilance.