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 with sufficient capacity or systems to perform these functions effectively.

Applying a systems-strengthening approach, SIAPS helps LMICs build more effective and efficient regulatory systems to achieve improved governance, increased technical capacity, better management and use of information, as well as to secure financing. As a starting point, SIAPS works with countries to deploy the Regulatory System Assessment Tool—developed under the SIAPS predecessor program, Strengthening Pharmaceutical Systems (SPS)—to identify gaps and deficiencies in their regulatory systems and assist national stakeholders to prioritize areas for improvement.

Guided by these findings, SIAPS collaborates 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.

To date, SIAPS has provided technical assistance to strengthen regulatory systems in 14 countries in Africa, Eastern Europe, and Asia.  Highlights include:

  • In Swaziland, SIAPS assisted the Ministry of Health to draft the Medicines and Related Substances Control Bill, which provides the legal mandate for establishing the first-ever NRA in the country. In addition to helping expedite the bill’s approval within the 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 has worked in partnership with the Department of Pharmacy and Medicines to strengthen the medicines registration process and build the capacity of the national medicines registration committee. This has led to an increase in the number of registered medicines, from 200 in 2010 to more than 2,000 in 2014. Additionally, 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 four countries (Bangladesh, Ethiopia, Mozambique and Namibia) have begun the process of implementing of an integrated, web-based information management system customized to their respective processes, which will help them manage and use regulatory information across all of the key regulatory functions. Beginning with product registration, SIAPS has 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 pre-requisite for automation of the information systems.

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