The new article describes the basics of international collaboration, aimed at further improvement of the regulatory framework and establishing a more efficient information exchange in order to ensure the proper performance of healthcare products as well as the safety of patients.
Table of content
The Drug Regulatory Authority of Pakistan (DRAP), a country’s agency in the sphere of healthcare products, has published a new revision of the guidelines on the national pharmacovigilance system. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, the authority reserves the right to make changes to the document, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Collaboration with the World Health Organization (WHO)
The World Health Organization (WHO), through its Programme for International Drug Monitoring (WHO-PIDM), plays a vitally important role in global pharmacovigilance efforts. Established in 1968 after the thalidomide tragedy, WHO-PIDM is a network connecting National pharmacovigilance centres from WHO member states.
Operational support for this programme is provided by the Uppsala Monitoring Centre (UMC) in Sweden, while WHO oversees policy-making, coordination, and the dissemination of drug safety information. WHO’s Essential Medicines and Health Products (EMP) department promotes access to quality, safe, and effective medical products and addresses medicine and vaccine safety as well as substandard or falsified products.
Through its Safety and Vigilance Section, WHO manages adverse event knowledge, mitigates risks, and ensures action against unsafe products. Key activities include issuing drug safety alerts, conducting annual meetings of pharmacovigilance centres, and publishing pharmaceutical newsletters that share information on safety signals and regulatory actions.
In Pakistan, the National Pharmacovigilance Centre (NPC) under the Drug Regulatory Authority of Pakistan coordinates with WHO on all pharmacovigilance matters. WHO’s collaborating centres, such as UMC (Sweden), WHO-CC (Morocco), and WHO-CC (Netherlands), provide support in areas like signal detection, medication errors, and patient education.
Uppsala Monitoring Centre (UMC)
The Uppsala Monitoring Centre (UMC) is an independent, non-profit foundation that manages the technical and scientific aspects of WHO-PIDM. Established in 1978, UMC serves as a hub for international pharmacovigilance research, training, and development.
It provides critical tools and resources, such as VigiBase (a global adverse event database), VigiFlow (a National ICSR management system), VigiLyze (a signal detection tool), and the WHO-Drug Dictionary. UMC supports National Centres through training and technical assistance.
It offers annual in-person training courses, distance-learning programs, and customized workshops. In addition to detecting signals in VigiBase, UMC disseminates findings to National Centres and publishes them in WHO newsletters.
Pakistani NPC coordinates with UMC to access tools like VigiFlow and VigiLyze, ensuring streamlined pharmacovigilance operations in the country.
Tools Provided by WHO-UMC
- WHO-Drug Dictionary – a comprehensive resource standardizes drug nomenclature and classifications, covering over 500,000 unique drug names and three million medicinal products globally. It is essential for coding medications during data entry into VigiFlow.
- VigiBase. As the largest global repository of individual case safety reports (ICSRs), VigiBase contains over 35 million anonymized reports from 157 countries. It facilitates the detection and analysis of medicine safety hazards using linked databases and standardized terminologies.
- VigiFlow – a web-based ICSR management system, VigiFlow supports the collection, assessment, and reporting of adverse drug reactions. It integrates tools like MedDRA and WHO-Drug, ensuring compliance with international standards. It also decentralizes data management, allowing regional and hospital-level centres to participate.
- VigiLyze. A powerful search and analysis tool, VigiLyze enables global, regional, or National-level signal detection. It offers qualitative and quantitative views, utilizing filters and disproportionality measures like the Information Component (IC) for advanced analysis.
- MedDRA (Medical Dictionary for Regulatory Activities): MedDRA provides a structured terminology for coding adverse events. Its hierarchical system aids in signal detection and ensures consistency across pharmacovigilance activities.
Conclusion
In summary, collaboration with international stakeholders, such as WHO and UMC, enhances Pakistan’s pharmacovigilance capacity by integrating global expertise, tools, and training. These partnerships facilitate access to advanced databases, signal detection technologies, and international best practices, ensuring the safe use of therapeutic goods and strengthening the country’s public health framework. The proactive engagement of NPC-DRAP with WHO and UMC underscores the country’s general commitment to aligning with global pharmacovigilance standards.
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