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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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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The current SEARVAP (South-East Asia regional vaccine action plan) describes a set of regional goals and objectives for immunization and control of vaccine-preventable diseases for 2016 – 2020 and highlights priority actions, targets and indicators that address the specific needs and challenges of... countries in the Region.
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First edition, November 1997 | Revised July 2002
Procedures Manual - Medicines registration in Madagascar - 2016 version
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
The resources provide both the older as well as the updated Operational Guidelines for antiretroviral therapy centres, including administrative issues, functions and establishment of centres, reporting and recording tools, measures to improve retention in HIV care, supply chain management of drugs a...nd various other aspects that are essential to ensure quality treatment for people living with HIV/AIDS.
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Report of a WHO technical consultation meeting
Ouagadougou, Burkina Faso
Act 851 | AN ACT to revise and consolidate the law relating to public health to
prevent disease, promote, safeguard, maintain and protect the health
of humans and animals and to provide for related matters.
A role for nuclear techniques
Antimicrobials play a critical role in the treatment of human and animal (aquatic and terrestrial) diseases, which has led to their widespread application and use. Antimicrobial resistance (AMR) is the ability of microorganisms to stop an antibiotic, such as an antimic...robial, antiviral or antimalarial, from working against them. Globally, about 700 000 deaths per year arise from resistant infections as a result of the fact that antimicrobial drugs have become less effective at killing resistant pathogens. Antimicrobial chemicals that are present in environmental compartments can trigger the development of AMR. These chemicals can also cause antibiotic-resistant bacteria (ARB) to further spread antibiotic resistance genes (ARG) because they may have an evolutionary advantage over non-resistant bacteria.
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