The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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Regulation of the Minister of Health of the Republic of Indonesia concerning guidelines for implementation of opioid replacement therapy program
A survey of prevention, testing and treatment policies and practices
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
Document No. : FDA/SMC/SMD/GL-RAR/2013/01
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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In 2018 and early 2019, the WHO Regional Office for Europe’s cultural contexts of health and well-being project worked alongside the University of Exeter’s WHO Collaborating Centre on Culture and Health, the Minsk Regional Centre for Psychiatry and Addiction, and the Institute of Mental Health o...f the Ukrainian Catholic University to engage researchers, practitioners, health-care workers and other relevant stakeholders in a series of workshops on the cultural contexts of early life trauma in Belarus and Ukraine.
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