Geneva, Switzerland — According to a recent report by the World Health Organization (WHO), about 70 percent of countries globally have regulatory systems considered weak or underdeveloped for evaluating medical products. These systems include oversight of pharmaceutical drugs, vaccines, and medical devices.
WHO-Listed Authorities (WLAs)
To strengthen global regulatory standards, the WHO designated several agencies as WHO-listed authorities (WLAs). WLAs are recognized for meeting the highest international regulatory benchmarks for medical products, ensuring their safety, quality, and efficacy.
Designated WLAs include:
- Health Canada
- Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency (MHLW/PMDA) of Japan
- Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom
Importance of Strong Regulatory Systems
Countries with robust regulatory authorities can prevent the distribution of substandard, falsified, or unsafe medical products, which can have severe public health implications. Weak systems increase risks such as:
- Administration of ineffective medications
- Distribution of unsafe or contaminated vaccines
- Reduced public trust in healthcare systems
Recommendations by WHO
The WHO urges countries with weaker regulatory systems to:
- Strengthen national regulatory authorities to align with international standards.
- Seek technical support from WLAs to ensure compliance with Good Regulatory Practices.
- Implement capacity-building programs for inspection, evaluation, and post-market surveillance of medical products.
- Promote transparency and accountability in pharmaceutical regulation.
Global Impact
Enhancing regulatory oversight is crucial not only for patient safety but also for supporting international trade in medical products, encouraging investment, and ensuring equitable access to life-saving interventions.
Soruce: WHO
