WHO outlines five-year regulatory action plan

In an effort to increase access to quality medical products around the world, the World Health Organisation (WHO) have created a five-year plan (2019–2023) to promote regulatory collaboration and reliance and to help National regulatory authorities (NRAs) solve ongoing challenges.  The plan is designed to help national regulators to deliver regulation that protects the public while enabling timely access to quality products and encouraging innovation by prioritising regulatory initiatives to help our Member States (MS) increase access to universal health coverage (UHC), support health emergency responses, and promote healthier populations.  Annual work plans with specific deliverables and key performance indicators (KPIs) will be prepared based on four strategic priorities.

  1. Expand international regulatory convergence and harmonisation

To help countries that lack adequate resources improve their regulatory systems by aiming for 50 countries to have improved regulatory systems by 2023 as a result of technical assistance provided by WHO.  Furthermore, at least 30 additional countries will have introduced a risk-based approach for regulating medical devices, including IVDs, as reflected in the WHO Global Model Regulatory Framework for medical devices.

  1. Improve regulatory preparedness for public health emergencies

To help regulators improve systems to ensure they are sufficiently robust and responsive in a public health emergency.  In five years, WHO expects that at least 10 additional low- and middle-income countries (LMIC) will have improved their regulatory infrastructure to address the specific challenges of public health emergencies, adopting features such as regulatory provisions for reliance, a fast-tracking registration process, and an effective and adapted pharmacovigilance system.

  1. Broaden the WHO/UN Prequalification Programme

To expanded the scope of prequalification to cover products important for additional priority diseases.  Procurement agencies and governments have come to rely on recommendations included in WHO Prequalification Lists regarding ensured quality products.  It is therefore critical to ensure that WHO continues to operate an efficient and effective Prequalification Programme. At the same time, new routes to prequalification listing will be developed to ensure optimal use of the processes and provide training.

  1. Increase the scope and impact of WHO’s regulatory support activities

To provide leadership in planning, coordination of delivery, and generating resources across the regulatory support activities.  WHO will develop annual action plans, and will implement and publish specific, measurable, achievable, relevant, time-bound (SMART) indicators to permit monitoring of progress towards objectives and goals.

WHO is committed to continuing its work in these and other areas in response to demands from Member States, and in consultation with various partners and stakeholders.

To read WHO’s five-year plan to help build effective and efficient regulatory systems, please click here.