Regional Workshop on implementation of good reliance practices for vaccines regulation based on emerging novel technologies

The WHO Regional Office for South-East Asia had organized a four-day regional hybrid workshop on implementation of good reliance practices for vaccines regulation based on emerging novel  technologies, in Pune, India, for the national regulatory authorities (NRAs) of Member States. 

COVID-19 vaccines produced through mRNA and other novel technologies have introduced many challenges for vaccine regulation such as approving facilities for multiproduct manufacturing. Approval of these new vaccines requires application of novel approaches with regulatory inspections and dossier assessment by the NRAs. NRAs, especially of non-vaccine producing countries, have limited resources and expertise for vaccine regulation. They must thus rely on other NRAs and NCLs for expedited and effective vaccine regulation to ensure timely and sufficient availability of vaccines for immunization programmes, including pandemic situations. This workshop was focused on supporting the NRAs in the Region to build expertise with good reliance practices (GRP) in the regulation of vaccines. 

Key takeaways from the workshop were training of Member State NRA staff on conducting virtual GMP inspections of vaccines produced through novel technologies including joint review of marketing authorization (MA) dossiers. This report provides an overview of the proceedings and action points from the workshop.