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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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Biovigilance: A Global Perspective.

Sukhjinder Singh1, Shammy Chandel2, Phulen Sarma1

  • 1Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

Perspectives in Clinical Research
|October 26, 2019
PubMed
Summary
This summary is machine-generated.

Biovigilance, crucial for monitoring biological products, involves detecting and preventing adverse events. Global biovigilance programs are expanding, with India launching its own national initiative to enhance safety.

Keywords:
Adverse eventsbiological productsbiovigilance

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Area of Science:

  • Biomedical Science
  • Public Health
  • Regulatory Science

Background:

  • Biological products, derived from human cells or tissues, carry risks like infection transmission and allergic reactions.
  • Biovigilance encompasses the detection, assessment, understanding, and prevention of adverse events (AEs) related to biological products.
  • The increasing market of biologicals and advancements in transplant services heighten the importance of robust biovigilance.

Purpose of the Study:

  • To review existing biovigilance systems in various countries.
  • To highlight the current needs and developmental stage of biovigilance programs globally.
  • To underscore the significance of biovigilance in ensuring the safety of biological products.

Main Methods:

  • Comparative analysis of biovigilance frameworks in developed nations (USA, Europe, Australia).
  • Examination of India's Biovigilance Programme of India, launched by the National Institute of Biologicals and Indian Pharmacopoeia Commission.
  • Literature review on the evolution and current status of biovigilance activities worldwide.

Main Results:

  • Developed countries have established nationwide biovigilance programs.
  • Biovigilance activities are still in their early stages globally, despite existing specialized systems like pharmacovigilance and materiovigilance.
  • India has initiated a national biovigilance program to address safety concerns.

Conclusions:

  • Biovigilance is essential for managing risks associated with biological products.
  • Harmonization and strengthening of global biovigilance systems are necessary.
  • The review provides insights into international best practices and identifies areas for improvement in biovigilance.