- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Mots-clés > desk assessment by NRAs - compliance with GMP, GLP, GCP, etc.
- Mots-clés > Good Manufacturing Practices (GMP)
- Mots-clés > National Medicines Regulatory Authority (NMRA)
- Mots-clés > national regulatory systems - assessment
- Mots-clés > prequalification of medicines
- Mots-clés > registration of pharmaceuticals
- Mots-clés > regulatory control
- Mots-clés > regulatory institutional capacity
- Mots-clés > regulatory systems
- Mots-clés > WHO/PQP and NMRAs - collaborative procedure
(2018; 7 pages)
The new Director General of the World Health Organization has stated that one of his top priorities is “Health for all” saying that “ensuring universal health coverage without impoverishment is the foundation for achieving the health objectives of the Sustainable Development Goals – because when people are healthy, their families, communities, and countries benefit.” He emphasized that “[the WHO’s] top priority must be to support national health authorities’ efforts to strengthen all the building blocks of health systems and to enact policies aimed at ensuring health care is equitable and affordable for all.” (http://www.who.int/dg/en/)
The issue – It is challenging to locate and interpret the regulatory requirements of many low and middle income (LMIC) countries...