6th edition, The NLEM 2021 contains 398 drugs molecules in different therapeutic categories.
Examination of the business behaviour of Boehringer Ingelheim, Bayer and Baxter in Uganda
A Summary
Accessed: 23.11.2019
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.
Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
Это руководство предназначено для использования в качестве пособия дл яврачей и других медицинских работников, осуществляющих лечение и уход за больными лекарст...енно-устойчивым туберкулезом.
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A comprehensive compilation is provided of the medicinal plants of the Southeast Asian country of Myanmar (formerly Burma). This contribution, containing 123 families, 367 genera, and 472 species, was compiled from earlier treatments, monographs, books, and pamphlets, with some medicinal uses and pr...eparations translated from Burmese to English. The entry for each species includes the Latin binomial, author(s), common Myanmar and English names, range, medicinal uses and preparations, and additional notes. Of the 472 species, 63 or 13% of them have been assessed for conservation status and are listed in the IUCN Red List of Threatened Species (IUCN 2017). Two species are listed as Extinct in the Wild, four as Threatened (two Endangered, two Vulnerable), two as Near Threatened, 48 Least Concerned, and seven Data Deficient. Botanic gardens worldwide hold 444 species (94%) within their living collections, while 28 species (6%) are not found any botanic garden. Preserving the traditional knowledge of Myanmar healers contributes to Target 13 of the Global Strategy for Plant Conservation
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manuel de mise en oeuvre de l’OMS
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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PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine quality control laborato...ry – the two key institutions to ensure the quality, safety, and efficacy of medicines. The MOH Pharmacy Taskforce (PTF) is to be commended however for successfully controlling the pharmaceutical market to the extent that there is no informal medicines market in Rwanda. Based on its findings, the assessment team expects Rwanda to be able to make great strides in evidence-based medicines quality assurance in the short to medium term, provided it receives adequate technical assistance and financial support.
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2014-2020, Draft March 2014
European Journal of Biomedical and Pharmaceutical Sciences, vol.3 (2016) 1, 192-206
This review shows that if all sub areas of pharmaceutical waste management can efficiently work back to back environmental pollution and dangers to human health can reduce significantly.
Introduction Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan
Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV.
Objective The objective of this initiative was to improve reporting of adverse events (A...Es) by strengthening passive safety
surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare
facilities (HCFs).
Methods An 18-month PV training and mentoring programme was implemented in collaboration with national stakeholders,
and in partnership with the Ministry of Health, GSK and PATH. Two-day training was provided to Expanded Programme on
Immunisation coordinators, identified as responsible for AE reporting, and four National Regulatory Authority representa-
tives. Abridged PV training and mentoring were provided regularly to HCPs. Support was given in upgrading the national
PV system. Key performance indicators included the number of AEs reported, transmission of AE forms, completeness of
reports, serious AEs reported and timeliness of recording into VigiFlow.
Results In 18 months, 443 HCPs at 61 HCFs were trained. The number of reported AEs increased from 22 (January 2000 to
October 2016) to 228 (November 2016 to May 2018), enabling Malawi to become a member of the World Health Organization
Programme for International Drug Monitoring. Most (98%) AE report forms contained mandatory information on reporter,
event, patient and product, but under 1% were transmitted to the national PV office within 48 h.
Conclusion Regular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi,
but the transmission of reports to the national PV centre requires further improvement.
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