Regulatory Systems Strengthening

While major global efforts have focused on promoting the availability of essential medicines in developing countries, less attention has been given to ensuring their safety and quality. In most countries, a nominated national regulatory authority (NRA) is responsible for ensuring the safety, efficacy, and quality of pharmaceutical products through key regulatory functions, including product registration, the inspection and licensing of pharmaceutical establishments, product quality testing, and medicine safety monitoring. However, many low- and middle-income countries (LMICs) do not have functioning NRAs that can perform these functions effectively.

By applying a systems strengthening approach, SIAPS helped LMICs build more effective and efficient regulatory systems to achieve improved governance, increased technical capacity, and better management and use of information and to secure financing. As a starting point, SIAPS worked with countries to deploy the Regulatory System Assessment Tool—developed under SIAPS’ predecessor program, Strengthening Pharmaceutical Systems—to identify gaps and deficiencies in their regulatory systems and help national stakeholders prioritize areas for improvement.

Guided by these findings, SIAPS collaborated with regulatory bodies to develop strategic plans; revise polices and legislation;  integrate international standards and best practices into the national guidelines, operating procedures, and other regulatory tools; and implement targeted capacity-building activities across all key regulatory functions.

SIAPS provided technical assistance to strengthen regulatory systems in  countries throughout Africa, Eastern Europe, and Asia.  Highlights included:

  • In Swaziland, SIAPS assisted the Ministry of Health to draft the Medicines and Related Substances Control Bill, which provides a legal mandate for establishing the first-ever NRA in the country. In addition to helping expedite the bill’s approval within parliament through targeted technical seminars and briefings, SIAPS worked with the MOH to develop an implementation plan for creating the new regulatory body.
  • In the Democratic Republic of the Congo, SIAPS worked in partnership with the Department of Pharmacy and Medicines to strengthen the medicine registration process and build the capacity of the national medicines registration committee. This led to a significant increase in the number of registered medicines. In addition, the list of registered medicines is now publicly available, regularly disseminated throughout the health system, and used by government inspectors to control medicines at ports of entry.
  • With SIAPS assistance, NRAs in Bangladesh, Ethiopia, Mozambique, and Namibia began the process of implementing of an integrated, web-based information management system customized to their respective processes that will help them manage and use regulatory information across all of the key regulatory functions. SIAPS worked with these NRAs to adopt international standards and best practices, such as use of the Common Technical Document for registration applications, and to make process improvements a prerequisite for automation of the information systems.

In addition to providing country-level technical assistance, SIAPS participated in several regional harmonization initiatives with the African Medicines Regulatory Harmonization program, the East African Community, and the Economic Community of West African States.