米索前列醇和米非司酮护理点质量检测的目标产品概况

Disease Area:Medical AbortionIntervention:(near) point-of-care quality detection devices Version:1.2March 2026 Table of Contents 24VERSION: 1.2 MARCH 2026................................................................................................1251BACKGROUND........................................................................................................3261.1 General....................................................................................................................3271.2 Purpose of this Target Product Profile...................................................................4282SUMMARY: INTERVENTION INDICATION AND TARGET USERS..........................5293.TPP 1 (UPPER LEVEL OF SUPPLY CHAIN): CORE VARIABLES...............................7304.TPP 2 (LOWER LEVEL OF SUPPLY CHAIN): CORE VARIABLES............................26313REFERENCES..........................................................................................................433233 1Background34 1.1General35 Comprehensive abortion care relies on access to quality-assured, affordable medical abortion medicines—36mifepristone, misoprostol, and co-packaged mifepristone-misoprostol (combi-pack)—including for self-managed37abortion. Increasing the availability of these medicines is essential to improve access and depends on medicines38policies and regulation, procurement and distribution, as well as health worker and end-user knowledge. Ensuring39the quality of abortion medicines, such as mifepristone and misoprostol, is essential for their safe and efficacious40use.41 Bothqualityassurance andqualitycontrol play crucial roles in this process, though they serve distinct functions.42Quality assurance is a proactive, process-driven approach that ensures abortion medicines are manufactured,43stored, and distributed under strict regulatory standards. It includes compliance with Good Manufacturing44Practices (GMP), supplier qualification, and continuous monitoring of production systems to prevent quality issues45before they arise. Quality assurancehelps ensure that only safe andefficaciousproducts enter the supply chain.46Quality control, in contrast, is a product-focused process that involves testing medicines at different points in the47supply chain to verify they meet established standards. This includes analyzing samples for active pharmaceutical48ingredient (API) content, detecting impurities, and assessing stability. Qualitycontrol is critical to confirming that49mifepristone and misoprostol tablets meet quality standards at the time they reach the end-user.50 Abortion medicines are distributed through diverse channels, including pharmacies, clinics, telemedicine services51(via post and internet services), and community health programs. In some settings, they are legally regulated,52while in others, access is restricted due to legal and social barriers. To ensure that good quality medical abortion53medicines are used, there is a need to advance quality testing methods and technologies.The current approach54to conducting quality surveys is to sample medicines in the field and send those samples to a laboratory for quality55testing.Several studies have been conducted in the last decade, identifying substandardmisoprostol and56mifepristonein multiple countries, which can lead to inadequate efficacy (lower amount of API leading to reduced57effectiveness) and safety concerns (such as impurities leading to increased risk of adverse reactions)1–3.58Stigmatized products such asmedicalabortion medicines are also more likely to be falsified. Indeed, falsified59products that do not contain any API have been found in circulation and remain a critical concern4.However,all60thesequality surveystudies are time-consumingandcostly,usinghigh-performance liquid chromatography, and61do not readily inform local decision-making, especially at the point of care.In addition, insome regulatory settings,62resources may be limited and anationalorcertifiedlaboratory may not be available to test suspected substandard63medicines. While samples can sometimes be sent to laboratories in neighboring countries, obtaining results may64take considerable time; in such situations, a quantitative device capable of providing numericalvaluesof the API65content in a tablet could offer valuable preliminary information.Having tools forquality controlat the point of66care would be valuablefor real-time monitoring that enables prompt action and decision-making to remove67substandard and falsified products from the supply chain.However, there are currently no methods for testing68mifepristone and misoprostol at this level.69 Point-of-care (POC) or near POC technologies have been developed fora range of medicines, includinginfectious70disease medicines,andcould be applied to abortion medicines5,6.Currently, fingerprint technologiesare available71to identify whether a given API is present in a finished pharmaceutical product (FPP)andspectroscopycan be72usedtoev