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.
more
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.
more
The document contains a set of indicators that can be used for monitoring traditional and complementary medicine (T&CM) systems in a country.
The core indicator set consists of 16 indicators that were considered essential and collectively able to provide information on T&CM inputs, processes and ou...tputs. A longer list of reference indicators is also available for countries that wish to monitor more indicators or that want to consider alternative metrics that would better suit each country’s T&CM situation, priorities and monitoring capacities.
Each core and reference indicator is accompanied by a set of metadata. This provides information on the indicator rationale, definitions, data elements (numerator, denominator and data disaggregation), frequency of measurement, and data sources. It is a guide towards more standardized data measurement as well as data interpretation.
more
Effective malaria prevention is threatened by widespread and increasing vector insecticide resistance. Failure to mitigate this threat will likely result in an increased burden of disease, with significant cost implications. This new framework provides support for the development of a national insec...ticide resistance monitoring and management plan as part of a national malaria strategic plan.
more
L’ampleur de la résistance aux insecticides chez les vecteurs du paludisme met en péril l’efficacité des programmes de lutte anti-vectorielle. Si cette résistance n’est pas atténuée, le taux de morbidité palustre va s’accroître, entraînant une hausse significative des coûts liés ... la prévention de la maladie. Ce nouveau cadre est un guide pour l’élaboration d’un plan national de suivi et de gestion de la résistance aux insecticides chez les vecteurs du paludisme, lequel doit considéré comme partie intégrante du plan stratégique national de lutte contre le paludisme.
more
The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
more
This report presents the findings from the Community Based Volunteers Skill Audit Survey that was carried out in 11 districts in Zambia as part of the Millennium Development Goal Acceleration Initiative.
Antimalarial drug resistance has emerged as a threat to global malaria control efforts, particularly in the Greater Mekong subregion. Drawing on data collected through more than 1000 therapeutic efficacy studies as well as molecular marker studies of Plasmodium falciparum drug resistance, the Report... on antimalarial drug efficacy, resistance and response: 10 years of surveillance (2010–2019) presents a decade’s worth of data on drug efficacy and surveillance, as well as recommendations to monitor and protect the efficacy of malaria treatment in the decades to come.
more
This document outlines the evaluation process that WHO undertakes to assess novel tools and strategies targeted at VBDs. Its aim is to articulate the linkage between the generation of evidence that demonstrates public health impact of novel interventions, and the development of policy recommendation...s based on the generated data. The document defines standards for the evaluation process, as well as the steps that an applicant needs to undertake, along with some guiding principles that aim to support applicants in the development of submissions with WHO.
more
Taking the whole of Africa approach to fighting the COVID-19 pandemic has and will continue to require coordinated efforts from multiple stakeholders from across the continent. Africa CDC would like to acknowledge the deep partnership and continued support of AUDA-NEPAD, AVAREF, WHO AFRO, the Bill a...nd Melinda Gates Foundation and the Mastercard Foundation. These partners have helped to shape and drive the continent’s strategic response to the COVID-19 pandemic and have offered support to ensure the continent receives a fair and equitable share of the COVID-19 vaccine without delay.
We look forward to continuing and deepening our partnership for the benefit of the public health of Africa.
more
The community-BFCI (c-BFCI) manual has been developed to facilitate training of CHVs and stakeholders providing nutrition sensitive services at community level. The manual covers a wide range of topics: basic nutrition, exclusive breastfeeding, complementary feeding, Breast Milk Substitutes Act, gro...wth monitoring and promotion, early childhood development and stimulation, household food and nutrition security and establishment of baby friendly communities.
more
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.
more
Annex 5, WHO Technical Report Series 1010, 2018
Global UNIDO Project: Strengthening the local production of essential medicines in least developed and developing countries
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.
Government of Nepal has an obligation to ensure availability of affordable and high quality basic health care services to its population