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.
Procedures Manual - Medicines registration in Madagascar - 2016 version
This Training module on malaria elimination has been developed by WHO to support health professionals in planning, managing, monitoring and evaluating malaria elimination programmes
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.
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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.
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This Training module on malaria elimination has been developed by WHO to support health professionals in planning, managing, monitoring and evaluating malaria elimination programmes.
Supporting exercises: These files are necessary for participants to complete a number of exercises listed in the man...ual. Please go to the website: http://www.who.int/malaria/publications/atoz/9789241549424/en/
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Government of Nepal has an obligation to ensure availability of affordable and high quality basic health care services to its population
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 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.
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This Handbook, an updated edition of the Management of Severe Malaria, provides new and revised practical guidance on the diagnosis and management of severe malaria.
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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