Outcomes-based regulation comes with benefits, but also presents challenges for regulators in measuring their influence and compliance by industry. In general, setting goals and facilitating business to meet them can be both a more effective and a less burdensome approach to meeting regulatory objectives than laying down lists of rules. A focus on outcomes can be important to enable innovation, as seen in the MHRA’s review of vaccines during the COVID-19 pandemic. The regulators’ and the Department’s focus on outcomes is welcome, but where such approaches are used, it is also important for a regulator to be able to measure the outcomes themselves and the extent of its influence over them. A regulator’s influence over the Principles of effective regulation 7 industry it regulates—for example, how well businesses comply with standards— can be difficult to measure, particularly if there are not specific rules that can be easily monitored. It is therefore crucial that regulators identify what data they need, collect this robustly and systematically, use it to monitor progress and have the power to act on it effectively. Recommendation: Government and regulators should work together to build in proper consideration of the right balance between outcomes-based and rules-based regulation in their sectors, to ensure regulatory objectives are not compromised and non-compliance by regulated entities does not go undetected. 8 Principles of effective regulation 1 Responding to challenges in the external environment