A guide for Regional Workshop and Hospital Technicians
These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M...edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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This document provides an overview of the issues and challenges surrounding medical device donations, and offers considerations and best practices that may be useful for making and soliciting donations. The document highlights the importance of an active participatory role for the intended recipient...s of medical equipment donations and emphasizes the importance of treating donations with the same rigour typically applied when purchasing medical equipment.
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Master of Science in Pharmaceutical Management Dissertation
Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
GOVERNMENT NOTICE | No. 192 Promulgation of Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), of the Parliament
First edition, November 1997 | Revised July 2002
J Nepal Health Res Counc 2013 May;11(24):198-204
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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