- Palabras clave > antimalarial medicines (AMLs)
- Palabras clave > artemisinin resistance
- Palabras clave > medicines quality assurance assessment
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > post marketing surveillance
- Palabras clave > quality assurance - medicines
- Palabras clave > regulatory assessment
- Palabras clave > regulatory institutional capacity
- Palabras clave > SSFFC medical products - surveillance and monitoring
- Palabras clave > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
(2017; 20 pages)
Substandard and falsified medicines are a major risk to public health. Substandard and falsified antimalarial medicines (AMLs) are of particular concern in the Greater Mekong Subregion (GMS) because of the spread of drug-resistant malaria. In order to minimize the potential impact of substandard and falsified AMLs and to support the elimination of artemisinin- and multidrug-resistant forms of malaria, there is a need for systematic strengthening of regulatory actions in this area. The World Health Organization (WHO) has taken important steps in addressing the issue by setting up the WHO Member State Mechanism for international collaboration and the Global Surveillance and Monitoring System and by conducting two regional training workshops in Asia and the Pacific in 2016.
In continuation of the previous training sessions, this workshop, co-organized by the WHO Regional Office for the Western Pacific, WHO Regional Office for South-East Asia and Asian Development Bank (ADB), included a one-day, high-level meeting of heads and senior managers of regulatory agencies in the GMS, followed by a two-day, hands-on practical training of regulatory inspectors and malaria supply chain managers.
The objectives of the training were to enhance risk-based, post-market surveillance and inspection of AMLs and other medicines, targeting high-risk areas within the supply chain and cross-border regulatory collaboration that will ultimately support the malaria elimination efforts in the GMS, and to strengthen the regulatory system capacity in general to counter substandard and falsified medicines in the Member States.
Partner organizations and the WHO regional offices also provided an overview of their objectives and activities in the regions. During the training workshop for practitioners, WHO headquarters focused on mapping supply chains and importation routes.
The meeting also provided opportunities for countries to share challenges and successes in improving quality testing, post-marketing surveillance practices and previous cases of detection of substandard and falsified products in the GMS.