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 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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This situation analysis has gathered information about the current state of AMR, contributing factors and antimicrobial use in Zimbabwe from the human, animal, agricultural and environmental sectors. Data has been gathered from different sectors such as the general public, academia, the Ministry of ...Health and Child Care, the Ministry of Agriculture Mechanization and Irrigation Development and the Ministry of Environment, Water and Climate. It shows that AMR is a real concern in Zimbabwe and a threat to the health outcomes of humans, to the economic productivity of the livestock industry and a risk to the environment.
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This report reviews and analyses the Affordable Medicines Programme, which was introduced in Ukraine in April 2017 to provide patients with improved access to 23 outpatient medicines for the treatment of chronic noncommunicable diseases. The evaluation combines both quantitative and qualitative anal...ysis. The findings confirm that the Programme has contributed to a significant increase in access to needed outpatient medicines in Ukraine. Further, while implementation was successful overall, uptake across regions was uneven. The report concludes by listing a number of policy options to support the sustainability and expansion of the Affordable Medicines Programme.
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The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in... 1948 recognized the need to establish a procurement service at WHO, and recommended setting up an office “to give advice on the procurement of essential drugs, biological products and other medical supplies”.
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Research Article
PLOS ONE | DOI:10.1371/journal.pone.0164619 October 13, 2016
Lancet Planet Health 2017 Published Online November 6, 2017 http://dx.doi.org/10.1016/S2542-5196(17)30141-9
These Guidelines on prudent use of antimicrobials in human health are based on a technical report prepared by the European Centre for Disease Prevention and Control (ECDC) with input from EU Member States experts and stakeholders, which should be referred to for details of the methodology used in cr...eating the guidelines as well as for additional references
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Human Resources for Health201816:49; https://doi.org/10.1186/s12960-018-0315-7
interim guidance, 23 December 2020
The speed of developing diagnostics for SARS-CoV-2, the causative agent of coronavirus disease 2019 (COVID-19), has been quite remarkable. Diagnostics have focused on nucleic acid amplification testing (NAAT) to identify infected individuals in acute-phase disease for timely implementation of mitiga...tion strategies and case management. More and more immunodiagnostics, mostly rapid diagnostic tests, are being made available as an alternative to NAATs. This type of test can be used out-of-laboratory conditions at large scale.
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