This manual has been designed to be used in conjunction with two earlier WHO publications, "Basic tests for pharmaceutical substances" (1986) and "Basic tests for pharmaceutical dosage forms" (1991). Most of the pharmaceutical substances and dosage forms covered are included in the WHO Model List of... Essential Drugs. The present volume describes procedures for testing a further 23 pharmaceutical substances and 58 pharmaceutical dosage forms and also for testing 4 medicinal plant materials.
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The global impact of COVID-19 has been profound, and the public health threat it represents is the most serious seen in a respiratory virus since the 1918 H1N1 influenza pandemic. Here we present the results of epidemiological modelling which has informed policymaking in the UK and other countries i...n recent weeks.
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Bull World Health Organ 2017;95:594–598
This document provides guidance on the application of non-pharmaceutical countermeasures to minimise the spread of the 2019 novel coronavirus (2019-nCoV) in the population. Some of the measures proposed refer specifically to certain phases of the epidemic (containment or mitigation phases), and can ...be adapted depending on the assessed severity/impact of the infection. Other measures are valid for all phases of an epidemic.
The guidance is based on the current knowledge of the 2019-nCoV and evidence available on other viral respiratory pathogens, mainly the Severe Acute Respiratory Syndrome coronavirus (SARS-CoV), the Middle East Respiratory Syndrome-related coronavirus (MERS-CoV) and seasonal or pandemic influenza viruses.
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This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
Rwanda Guidelines for variation to registered pharmaceutical products.
ECDC is now offering a series of micro learning activities related to COVID-19 (the disease causing the 2019 novel coronavirus outbreak). The e-learning activities are available in the ECDC Virtual Academy (EVA). https://eva.ecdc.europa.eu/mod/scorm/view.php?id=9691
The short e-learning activitie...s provide guidance on the application of non-pharmaceutical countermeasures and include five sessions.
1. Introduction to COVID-19 NPC
2. Personal protection against COVID-19
3. Environmental countermeasures against COVID-19
4. Social distancing countermeasures against COVID-19
5. Travel-related countermeasures against COVID-19
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The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan...cements, industry practices and regulatory expectations specific to the vaccine manufacturing context. Some of the topics include computer system validation, data integrity, challenges in lyophilization and others. Real world examples and case studies will be used to show how to interpret current and recently new good manufacturing practices requirements from a practical point of view and to implement appropriate approaches.
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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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