Regulatory Standards Assistance Program (RSAP)
Recognizing the vital importance of quality-assured medicines to patients and healthcare providers, in 2011 USP launched the Regulatory Standards Assistance Program (RSAP), formerly the Technical Assistance Program (TAP), to provide developing countries with tools to increase their capacity to test the quality of medicines for their citizens. RSAP began with just five countries in Africa—Ethiopia, Ghana, Kenya, Senegal, and Sierra Leone—and since then has expanded to include more than 35 countries in Africa, Asia, and Latin America and the Caribbean.
What Does RSAP Provide?
Participating countries receive a comprehensive package of primary Reference Standards selected by the participating country from USP’s catalog (up to a specified value), documentary standards, and analytical data to test medicines. USP and other major pharmacopoeias typically sell Reference and documentary standards for use by pharmaceutical manufacturers and quality control (QC) laboratories. Laboratories with limited resources may rely on outdated, secondary, or inadequately documented standards, which in turn may compromise QC testing or lead to questionable analytical test results. RSAP’s provision of current standards is intended to limit reliance on secondary standards.
A few ways that countries with limited resources can benefit from participating in RSAP include:
- Strengthening their capacity to identify substandard and counterfeit medicines, which in turn can improve access to good quality medicines, reduce the burden of disease, and, ultimately, promote public health;
- Addressing potential public health emergencies by providing the standards required to test medicines quality prior to distribution;
- Reallocating funds invested in secondary standards toward improving laboratory capacity; and,
- Enabling QC laboratories to test medicines for purity, an important quality attribute.
Impact of RSAP
To assess the public health impact of RSAP, USP works with participating countries to develop and track quantitative and qualitative metrics, such as the number and variety of medicines tested, the number of substandard or counterfeit medicines detected, and any other peripheral benefits that result from participation in the program. Information received to date from participating countries indicates an increased use of primary Reference Standards to conduct quality control testing, with concomitant improvements in lab data quality and capacity, reduced sample testing time, and a broader range of samples tested.
Who is Eligible to Participate?
Official Medicines Control Laboratories are eligible to participate in RSAP. Any country in the process of constructing a national laboratory may apply to participate and, if accepted, would receive USP documentary standards.
- Vice Director of NIDQC, Dr. Tran Viet Hung, Explains the Benefits of Participating in RSAP (YouTube video)
Media coverage of RSAP:
- Dr. Patrick Lukulay discusses RSAP (YouTube video)
- International Training to Assist Governments of Five African Nations in Detecting Poor-Quality, Counterfeit Medicines
- Medicines Quality in Five Sub-Saharan African Countries to Benefit from USP Pilot Program
To learn more about RSAP, contact Mr. Hari Ramanathan, Manager, Global Health Programs, +1-301-816-8313, email@example.com.