TY - JOUR T1 - Strengthening regulatory systems for medicines in a changed world: where do we go from here? JF - BMJ Global Health JO - BMJ Global Health DO - 10.1136/bmjgh-2020-004680 VL - 6 IS - 1 SP - e004680 AU - Julie O'Brien AU - Rebecca Lumsden AU - Judith Macdonald Y1 - 2021/01/01 UR - http://gh.bmj.com/content/6/1/e004680.abstract N2 - Summary boxStrengthening regulatory systems for medicines in low-income and middle-income countries is critical to ensure fit for purpose, future-proofed and efficient regulatory systems that facilitate access to safe and effective medicines for patients; this holds true before, during and after the COVID-19 pandemic.The COVID-19 pandemic has shone a light on weaknesses in regulatory systems around the globe, such as lack of digital adoption, and has precipitated the implementation of long-term aspirations for regulatory strengthening.National Regulatory Authorities around the world have demonstrated an extraordinary ability to adapt, including implementation of new ways of working, to fulfil their role both in relation to continued supply of existing critical medicines and review and approval of new innovative medicines (including but not limited to potential COVID-19 vaccines and treatments).Regulatory strengthening measures implemented during the COVID-19 pandemic can enhance regulatory systems more broadly beyond the current health emergency.National regulatory authorities (NRAs) play a vital role in the regulation of medicines globally. A diverse spectrum of NRAs exists, from those with less well-developed systems to those with well-established, advanced systems. Over the past several decades, great strides have been made to strengthen regulatory systems across the globe. For example, greater harmonisation of technical standards via The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use,1 adoption of WHO initiatives such as Good Regulatory Practices2 and the Global Benchmarking Tool,3 greater use of digital tools and more international cooperation and collaboration–including regulatory reliance mechanisms—between regulatory authorities. These initiatives are essential because strong regulatory systems streamline the regulatory review and approval process, facilitating access to safe and effective medicines to patients.3 Never has this endeavour felt more critical.In December 2019, the first reports of a new virus began to emerge. Since then, over 60 million people globally have … ER -