This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
Externalizing disorders
Chapter 1.1
Other disorders Chapter H.1
Psychiatrie de l'enfant
Chapitre B.1
Edition en français
Traduction : Apolline Morville
Sous la direction de : Priscille Gérardin
Avec le soutien de la SFPEADA
The revised guidelines present two major changes to existing guidelines: (A) there are now just 2 categories of pneumonia instead of 3 (“pneumonia” which is treated at home with oral amoxicillin and “severe pneumonia” which requires injectable antibiotics) and (B) oral amoxicillin replaces o...ral cotrimoxazole as first line treatment, preferably in 250mg dispersible tablet form, twice daily for five days which can be reduced to three days in low HIV settings.
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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 guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
The WHO Model List of Essential Medicines and Model List of Essential Medicines for Children are updated and published every two years, intended as a guide for countries or regional authorities to adopt or adapt in accordance with local priorities and treatment guidelines for the development and upd...ating of national essential medicines lists. Selection of a limited number of essential medicines as essential, taking into consideration national disease burden and clinical need can lead to improved access through streamlined procurement and distribution of quality-assured medicines, support more rational or appropriate prescribing and use and lower costs for both health care systems and for patients.
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Report of the 23rd WHO Expert Committee on the selection and use of essential medicines
This executive summary reports the recommendations made by the Expert Committee for the 2021 update of the WHO Model List of Essential Medicines (EML) and the Model List of Essential Medicine for Children (EMLc)....
The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes and deletions of medicines, medicine classes and formulation on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for comparative effectiveness, safety and cost-effectiveness of the medicines in question. The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists, and update to the AWaRe classification of antibiotics, and reviews and reports relevant to the selection and use of essential medicines.
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Rwanda Guidelines for variation to registered pharmaceutical products.
The document provides detailed guidelines for the production, formulation, and implementation of oral rehydration salts (ORS) to combat dehydration caused by diarrhoea, particularly in children. It focuses on the composition, quality standards, and packaging requirements of ORS, aiming to support na...tional authorities and healthcare providers in ensuring effective and accessible treatment. It also highlights strategies for manufacturing ORS locally while adhering to international health and safety standards.
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