Pharmacovigilance regulations: US vs Europe comparison
Journal name: World Journal of Pharmaceutical Research
Original article title: Regulatory aspects of pharmacovigilance along with comparision in united states and europe
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
This page presents a generated summary with additional references; See source (below) for actual content.
Original source:
This page is merely a summary which is automatically generated hence you should visit the source to read the original article which includes the author, publication date, notes and references.
Anisha Sharda, Ruchi Patel, Naishi Patel, Hiral Vyas, Payal Dixit
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Regulatory aspects of pharmacovigilance along with comparision in united states and europe
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Copyright (license): WJPR: All rights reserved
Download the PDF file of the original publication
Summary of article contents:
Introduction
Pharmacovigilance, also known as drug safety, is a scientific discipline concerned with the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Its primary goal is to improve patient safety and public health by collecting and analyzing data on adverse drug reactions (ADRs). Various countries have developed specific regulatory frameworks to guide pharmacovigilance activities, ensuring that drug safety information is accurately gathered, assessed, and utilized.
Adverse Event Reporting
Adverse Event Reporting is one of the core activities in pharmacovigilance. It involves the systematic receipt, triage, data entry, assessment, and distribution of adverse event (AE) data from various sources such as healthcare professionals, patients, clinical studies, literature, and media. Key elements that define an AE report include an identifiable patient, an identifiable reporter, a suspect drug, and an adverse event. This process is crucial for maintaining the risk-benefit profile of a drug, helping regulatory authorities and pharmaceutical companies take appropriate actions for drug safety.
Risk Management
Risk management is a critical aspect of pharmacovigilance that focuses on signal detection and the continuous monitoring of the risk-benefit profile of drugs. It involves the creation of Risk Management Plans (RMPs), which describe the risks associated with a drug and the measures to minimize those risks. In the U.S., the FDA may require a Risk Evaluation and Mitigation Strategy (REMS) for drugs with specific risks, whereas in the EU, an RMP is mandatory for new market authorization requests. These plans ensure that the benefits of a drug outweigh its risks under the conditions of use.
International Collaboration
International collaboration in pharmacovigilance is essential for effective drug safety monitoring globally. Organizations like the Council for International Organizations of Medical Sciences (CIOMS) and the International Conference on Harmonisation (ICH) provide guidelines and frameworks to harmonize pharmacovigilance practices. The World Health Organization (WHO) also plays a pivotal role, promoting international cooperation through its International Drug Monitoring Programme. This initiative encourages member countries to share and analyze adverse drug reaction reports, leading to the detection of safety signals and coordinated regulatory responses.
Conclusion
Pharmacovigilance has evolved into a vital component of public health programs, with an expanding scope due to the increasing number of pharmaceutical products. The global nature of drug usage necessitates better coordination among drug regulators worldwide. Effective partnerships and commitments are critical to address the emerging challenges in pharmacovigilance. Harmonizing guidelines across countries can significantly enhance drug safety monitoring, ultimately contributing to better health outcomes for populations globally.
FAQ section (important questions/answers):
What is pharmacovigilance?
Pharmacovigilance, also known as drug safety, is the science of collecting, detecting, assessing, monitoring, and preventing adverse effects with pharmaceutical products, including adverse drug reactions (ADRs).
What are the 'four elements' of an adverse event case?
The 'four elements' of an adverse event case are: 1) an identifiable patient, 2) an identifiable reporter, 3) a suspect drug, and 4) an adverse event.
What is expedited reporting?
Expedited reporting involves the submission of Individual Case Study Reports (ICSRs) that include serious and unlabelled events related to drug use, typically within 15 calendar days of notification.
What is an RMP?
An RMP (Risk Management Plan) describes the risks associated with a drug, including identified, potential, and unknown risks, and outlines measures to minimize these risks to maintain a positive risk-benefit profile.
How is pharmacovigilance coordinated in the EU?
In the EU, pharmacovigilance is coordinated by the European Medicines Agency (EMA) and conducted by the National Competent Authorities (NCAs) with a system called EudraVigilance.
What is the role of WHO in pharmacovigilance?
The WHO facilitates international collaboration in pharmacovigilance through its International Drug Monitoring Programme, processing reports from over 100 member countries to detect safety signals and alert member nations.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for 鈥淧harmacovigilance regulations: US vs Europe comparison鈥�. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
The term 'drug' is fundamental to pharmacovigilance, a field dedicated to studying the safety and effectiveness of drugs. It encompasses pharmaceuticals used for treating, diagnosing, or preventing diseases. Pharmacovigilance monitors drugs for adverse reactions, ensuring they provide more benefit than harm to public health.
2) Medicine:
Medicine refers to substances or preparations used in treating diseases or medical conditions. In pharmacovigilance, 'medicine' is the broader category that includes drugs. Monitoring the safety and efficacy of medicines ensures that they are beneficial and reduces the risk of adverse effects, thus safeguarding public health.
3) Post:
The term 'post' in pharmacovigilance context often refers to 'post-marketing', a phase where a drug is continuously monitored after it has been released into the market. Post-marketing surveillance ensures the ongoing safety and efficacy of pharmaceuticals through the collection and analysis of adverse event reports.
4) Knowledge:
Knowledge in pharmacovigilance is essential for understanding drug safety and efficacy. It encompasses data from adverse event reports and clinical trials, which help regulatory bodies and pharmaceutical companies develop strategies to minimize risks associated with drug use, ultimately protecting public health.
5) Science (Scientific):
Science is foundational to pharmacovigilance, which relies on scientific methods to collect, analyze, and interpret data on adverse drug reactions. This scientific approach ensures evidence-based decisions and strategies to enhance drug safety and efficacy, promoting better health outcomes.
6) Pharmacological:
Pharmacological pertains to the study of drugs and their effects on the body. In pharmacovigilance, it involves understanding how drugs interact with biological systems to detect, assess, and prevent adverse reactions, ensuring that medications are both safe and effective for patients.
7) Toxicity:
Toxicity refers to the degree to which a substance can harm humans. In pharmacovigilance, evaluating a drug's toxicity is crucial for identifying and minimizing adverse reactions. Pre-screening drugs for toxicity and continuous monitoring help ensure that medicines do more good than harm.
8) Activity:
Activity in pharmacovigilance involves various processes like adverse event reporting, assessment, and risk management. These activities are crucial for maintaining drug safety, monitoring the effects of medications, and implementing measures to mitigate risks, thereby protecting public health.
9) Misuse:
Misuse of drugs, including overuse or incorrect use, can lead to adverse drug reactions. Pharmacovigilance aims to identify and prevent misuse by monitoring drug safety and educating healthcare professionals and the public about the proper use of medications, thus reducing the risk of harm.
10) Ruci (Ruc墨):
Ruchi Patel is one of the authors of the article, contributing to the study and presentation of pharmacovigilance regulatory aspects. Co-authors like Ruchi Patel play a significant role in researching and disseminating knowledge that informs practices and policies in drug safety and efficacy.
11) Hand:
Hand does not directly appear in the text, but metaphorically, it could refer to the involvement or role of different stakeholders ('hands') in the pharmacovigilance process. Collaboration between regulatory authorities, pharmaceutical companies, and healthcare professionals (鈥榟ands鈥�) is crucial for effective drug safety monitoring and risk management.
Other Science Concepts:
Discover the significance of concepts within the article: 鈥�Pharmacovigilance regulations: US vs Europe comparison鈥�. Further sources in the context of Science might help you critically compare this page with similair documents:
Control group, Clinical trial, Adverse drug reaction, Pharmacogenomics, Placebo, Pharmaceutical companies, Public health program, Pharmacogenetics, Pharmacovigilance, Adverse Event Reporting, Causality assessment, Serious Adverse Event, Spontaneous Reporting, Risk Management, Pharmacoepidemiology, National Pharmacovigilance Programme, Gold standard, FDA, European Medicines Agency, Pharmacovigilance system, Risk management plan.