Access to safe, effective and quality-assured health products and technologies is crucial for achieving universal health coverage and primary health care goals. The continued growth of the aging population; increasing burden of noncommunicable diseases; growing burden of mental health issues; climat...e change; shifting patterns of vector borne diseases, fungal disease and waterborne diseases; antimicrobial resistance; and new infectious hazards create an ongoing need for equitable access to safe, effective and quality-assured health products and technologies, and renewed investments in research and development for innovative health products and technologies.
The coronavirus pandemic exposed the inequalities in access to health products, highlighting the need for longer-term strategies to strengthen access to health products and technologies outside of and in emergency situations. While technological and scientific advances present an opportunity to increase access to health products and technologies, the risk of increasing inequality due to higher prices for new health products and technologies; the persisting problem of substandard and falsified medical products; a lack of skilled workforce in many low- and middle-income countries; and a lack of data for decisionmaking and for measuring progress present significant challenges.
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Basado en la Metodología POLARIS de Seguimiento Farmacoterapéutico, desarrollado por
Facultad de Química de la Pontificia Universidad Católica de Chile.
Guía de medicamentos esenciales para primer nivel de atención – Edición 2019
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
The Malawian government recently introduced cost-covering consultation fees for self-referral patients in tertiary public hospitals. Previously, patients received medicines free of charge in government-owned health facilities, but must pay elsewhere. Before the government implements a payment policy... in other areas of health care, it is important to investigate the prices, affordability and availability of essential medicines in Malawi.
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The Kenyan Health Sector has been playing a critical role in
providing health care services in response to the population
needs in line with the Kenya Health Policy, 2014-2030’s goal
of attaining the highest possible health standards in a manner
responsive to the population needs.
Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition
Community pharmacists are the health professionals most accessible to the public and are a cornerstone of primary health care. The role of community pharmacists is expanding globally. This report provides an overview of existing components and provisions of the legal and regulatory framework for com...munity pharmacies and their activities in Europe. It presents the diverse approaches to community pharmacy licenses and to establishment of new pharmacies and their ownership. It also details the framework for community pharmacy operating requirements (including opening hours, workforce, premises and equipment, services provided and identification of a community pharmacy) and the types of activity undertaken. Provisions associated with possible alternative forms of dispensing medicines (over-the-counter medicines, prescription-only medicines, dispensing by medical doctors and online medicine sales) are also described
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Rwanda Guidelines for variation to registered pharmaceutical products.
Capability and Performance
The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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