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Medicines are at the core of every health system. The World Health Organization recommends countries develop national medicines policies that guide production, procurement, prescription and provision of medicines so that people can access the medicines they need at prices they can afford, while avoiding irrational use. However, the development of such policies is rarely straightforward. We describe important components of the national medicines policy in Saudi Arabia, which was developed within a broader transformation of the health system and the economy. The new policy formalizes existing best practices, shapes emerging policies and sets a direction for future development in four main areas. First, the policy seeks to consolidate institutional roles to provide greater cohesion; second it aims to reshape procurement and prescribing habits, with a greater focus on cost containment; third, it lays out policies which focus on assuring a secure supply of good-quality medicines, including essential medicines with limited profit potential and new products. Finally, the policy supports the growth of the domestic pharmaceutical industry, including the development of human resources. Many sectors and institutions joined in the development of the medicines policy, which was underpinned by a review of the past and current pharmaceutical context in Saudi Arabia, and good practices globally. The resulting policy was built on evidence and endeavours to give clear direction to the pharmaceutical industry and implementing agencies on rules and requirements, professional norms and institutional roles. At the same time, it maintains flexibility to allow for adaptation in a rapidly evolving institutional landscape. [phrase omitted] [phrase omitted] Les medicaments sont au creur de tout systeme de sante. LOrganisation mondiale de la Sante recommande aux pays d'elaborer des politiques pharmaceutiques nationales qui determinent la production, l'obtention, la prescription et la fourniture de medicaments, afin que la population puisse acceder aux traitements requis a un prix abordable sans toutefois tomber dans un usage irrationnel. Mais cette elaboration est rarement simple. Dans le present document, nous abordons les principaux aspects de la politique pharmaceutique nationale en Arabie saoudite, developpee dans le cadre d'une vaste transformation de l'economie et du systeme de sante. Cette nouvelle politique officialise les bonnes pratiques existantes, faconne les projets emergents et definit une orientation pour l'evolution future dans quatre domaines cles. Premierement, elle cherche a renforcer le role des institutions pour ameliorer la cohesion. Deuxiemement, elle vise a remanier les habitudes d'obtention et de prescription, en se focalisant sur la maitrise des couts. Troisiemement, elle etablit des mesures destinees a assurer un approvisionnement sur en medicaments de qualite, y compris en nouveaux produits et medicaments essentiels au potentiel de rentabilite limite. Et quatriemement, elle soutlent la crolssance de l'industrie pharmaceutique dans le pays, notamment le developpement des ressources humaines. De nombreux secteurs et institutions ont contribue a l'elaboration de cette politique, qui s'appuie sur une analyse du contexte pharmaceutique anterieur et actuel en Arabie saoudite ainsi que sur les bonnes pratiques mondiales. Le resultat repose sur des elements et efforts tangibles. Il montre clairement a l'industrie pharmaceutique et aux organismes de mise en reuvre la marche a suivre en matiere de regles et d'exigences, de normes professionnelles et de roles institutionnels. Et dans le meme temps, il prevoit suffisamment de flexibilite pour s'adapter a un paysage institutionnel en constante mutation. [phrase omitted] Los medicamentos son el nucleo de todo el sistema sanitario. La Organizacion Mundial de la Salud recomienda a los paises que desarrollen politicas nacionales de medicamentos que guien la produccion, la adquisicion, la prescripcion y el suministro de estos, de modo que las personas puedan acceder a los medicamentos que necesitan a precios que puedan pagar, evitando al mismo tiempo un uso irracional. Sin embargo, la elaboracion de estas politicas no suele ser sencilla. En este documento se describen componentes importantes de la politica nacional de medicamentos en Arabia Saudita, que se desarrollo en el marco de una transformacion mas amplia del sistema sanitario y la economia. La nueva politica formaliza las mejores practicas existentes, da forma a las politicas emergentes y establece una direccion para el desarrollo futuro en cuatro areas principales. En primer lugar, la politica busca consolidar las funciones institucionales para proporcionar una mayor cohesion; en segundo lugar, pretende remodelar los habitos de adquisicion y prescripcion, centrandose mas en la contencion de los costes; en tercer lugar, establece politicas que se centran en asegurar el suministro de medicamentos de buena calidad, incluidos los productos nuevos y los medicamentos esenciales con un potencial de beneficio limitado. Por ultimo, la politica apoya el crecimiento de la industria farmaceutica nacional, incluido el desarrollo de los recursos humanos. Varios sectores e instituciones participaron en la elaboracion de la politica de medicamentos, que se sustento en una revision del contexto farmaceutico pasado y actual en Arabia Saudita, y de las buenas practicas a nivel mundial. La politica resultante se creo a partir de pruebas y se esfuerza por dar una orientacion clara a la industria farmaceutica y a los organismos de ejecucion sobre las reglas y requisitos, las normas profesionales y las funciones institucionales. Asimismo, mantiene la flexibilidad para permitir la adaptacion en un panorama institucional que evoluciona muy rapido., Introduction Pharmaceuticals--medicines, vaccines and diagnostic tests--and medical equipment are at the centre of any health system, and are central to good clinical practice. The World Health Organization (WHO) recommends that [...]

Background: Substandard and falsified medicines (SFMs) are a public health concern of global importance. Postmarket surveillance in the form of medicine sampling and quality testing can prevent and detect SFM, however, there is remarkably scarce evidence about the cost and value for money of these activities: how much do they cost and how effective are they in detecting SFM?, Methods: Between February and October 2022, Systematic Tracking of At Risk Medicines (STARmeds) collected and analysed for quality 1274 samples of 5 medicines from physical and online retail outlets in 7 Indonesian districts. We collated data on the resources consumed by STARmeds, related to all stages of medicines sampling and quality testing including design, fieldwork and laboratory analysis. We used activity-based costing principles to calculate the financial and economic cost of medicine quality surveillance from the perspective of a hypothetical medicines' regulator. We calculated the cost per day and per week of fieldwork, per sample collected and per substandard sample. We used bootstrapping to capture uncertainty in the number of samples collected, by seller location type (urban, rural and online)., Results: The total cost of sampling and testing medicines from the market was US$712 964 (current 2022 values). Laboratory costs represented the largest share (70%), followed by other direct costs (12%) and indirect costs (7%). On average, it costs STARmeds US$479 (95% CI US$462 to US$516) to collect one medicine sample and US$5990 (95% CI US$5601 to US$6258) to identify one substandard sample., Conclusion: Our findings bring urgently needed and novel information on the cost and value for money of medicine quality surveillance. These may support planning and budgeting of the Indonesian pharmaceutical regulator, but also of regulators and researchers elsewhere, particularly in low-income and middle-income settings, as well as international organisations with health regulation and quality of care remits., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)