WHO: Draft for Reliance in Regulatory Decision-making

The World Health Organization (WHO) supports the implementation of reliance on other regulators’ work as a general principle, making optimal use of available resources and expertise. When built upon Good Regulatory Practices (GRP), Good Reliance Practices (GReIP) allows national regulatory authorities (NRAs) to concentrate on regulatory activities (which cannot be done other authorities) like in-country vigilance activities and management of local manufacturing and distribution. Prompt access to safe, effective, and quality-assured medical products can bring benefit in regulatory readiness and response, especially during public health emergencies.

The WHO is in the process of establishing and implementing a framework for evaluating and designating NRAs that meet a specific standard as WHO-Listed Authorities (WLAs). Assessment and qualification provide a recognised, empirical, and transparent system that can be leveraged by NRAs as a reference to practise reliance.

To read more, visit the WHO website here.

Source: World Health Organisation (WHO)

Contact us at info@arqon.com