The country profiles incorporate facts indicating the national status of medical devices in areas such as: medical device policies, regulations, incorporation, lists, inventories, nomenclature, health technology assessment, management, and biomedical engineering resources. This publication is int...ended for use as a reference by decision-makers in Ministries of Health, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional, or global levels.
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Global UNIDO Project: Strengthening the local production of essential generic drugs in the least developed and developing countries
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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This guidance should be followed if an unlicensed medicine is prepared in
a registered pharmacy. The preparation of an unlicensed medicine (for
example unlicensed methadone, or menthol in aqueous cream) in a pharmacy is called ‘extemporaneous preparation’.
The guidance should be read alon...gside the standards for registered pharmacies. These aim to create and maintain the right
environment, both organizational and physical, for the safe and effective practice of pharmacy.
By following this guidance, the pharmacy will:
• demonstrate that it meets our standards, and
• provide assurances that the health, safetyand wellbeing of patients and the public are safeguarded
Responsibility for making sure this guidance is followed lies with the pharmacy owner. If the registered pharmacy is owned by a ‘body
corporate’, the directors have responsibility.
Those responsible for the overall safe running of the pharmacy need to take into account the nature of the pharmacy and the range of services
already provided and, most importantly, the needs of patients and members of the public.
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The Federal Ministry of Health (FMOH) has been coordinating sector wide reforms that aim to improve equity and quality of health services. It is widely known that; the sector is growing in line the overall growth and transformation plan of the country and the sector is bein...g guided by the health sector transformation plan (HSTP). As part of these efforts, to achieve the targets set, the sector identified information revolution as one of the transformational agendas. In the meantime, Appropriate and timely use of health and health-related information is an essential element in the process of transforming the health sector.
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2014-2020, Draft March 2014
The United Nations Commission on Life-Saving Commodities (UNCLSC, 2012) defined 13 health products to end preventable deaths of woman and children. One of those 13 products is the neonatal resuscitator, is indispensable medical device to save newborns from asphyxia at birth. For the efficient use of... neonatal resuscitation, training of healthcare professionals using neonatal resuscitation manikins is the most effective approach. Critical lifesaving trainings calls for the need of neonatal resuscitation manikins with the right features.
The purpose of the WHO Neonatal resuscitation manikin: technical specifications is to provide a minimum standard baseline to meet the increasing demand to procure good quality, affordable, accessible, and appropriate neonatal resuscitation manikins. Towards the development of this baseline, this document includes compilation of available scientific evidence from technical literature, international publications, expert reviews, and an industry survey which was conducted by WHO medical devices team.
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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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The infectious disease burden in India is among the highest in the world. A large amount of antibiot-ics are consumed in fighting infections, some of them saving lives, but every use adding to antibiotic resistance in bacteria. Antibiotic use is increasing steadily (table 1), particularly ... certain antibiotic classes (beta-lactam antibacterials), most notably in the more prosperous states. Resistance follows in lock-step.
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