Regulatory frameworks and surveillance

Regulatory authorities ensure access to safe, effective and quality-assured medicinal products, thereby strengthening the performance and sustainability of health systems.

Pre-authorization clinical trials can establish benefits of health products. Post-marketing pharmacovigilance, however, is also critical to identify risks and potential rare events. This information may be used to update labelling of marketed health products.

WHO and other global and regional bodies, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), provide support through guidelines, checklists and training materials to encourage regulators to allow the inclusion of pregnant and lactating women in clinical trials.