- All > Quality and Safety: Medicines > Quality Assurance
- All > Quality and Safety: Medicines > Regulatory Support
- All > Quality and Safety: Medicines > Safety and Efficacy
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Keywords > lot release of vaccines - regulatory authorities
- Keywords > national vaccine control laboratories
- Keywords > prequalification for vaccines
- Keywords > Prequalification of diagnostics, medicines and vaccines - WHO
- Keywords > quality control - lot testing
- Keywords > safety and efficacy
- Keywords > vaccine control
- Keywords > vaccines - Network of national control laboratories (NCLs)
- Keywords > WHO-National Control Laboratory Network for Biologicals
(2017; 8 pages)
Immunization is one of the most cost-effective public health interventions. However, vaccines are complex biological products that need comprehensive regulatory oversight, including control of each lot released onto the market. For WHO-prequalified vaccines, lot release is under the responsibility of the authority with the regulatory oversight of the respective vaccine, which is usually the national regulatory authority (NRA) of the producing country.
Lot release testing of vaccines is becoming more demanding and resource-intensive as globalization and scientific advances progress, making it necessary for national control laboratories (NCLs) to collaborate in order to ensure the timely supply of quality-assured vaccines to countries. With this in mind, WHO has brought together representatives of NCLs involved in testing of WHO-prequalified vaccines, industry and other stakeholders to explore the potential for more extensive sharing of work and information. A network of NCLs responsible for release of WHO-prequalified vaccines was established.