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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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.
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.
This report reviews and analyses the Affordable Medicines Programme, which was introduced in Ukraine in April 2017 to provide patients with improved access to 23 outpatient medicines for the treatment of chronic noncommunicable diseases. The evaluation combines both quantitative and qualitative anal...ysis. The findings confirm that the Programme has contributed to a significant increase in access to needed outpatient medicines in Ukraine. Further, while implementation was successful overall, uptake across regions was uneven. The report concludes by listing a number of policy options to support the sustainability and expansion of the Affordable Medicines Programme.
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Manual for use in primary care.
There is substantial evidence for the benefits of screening and brief intervention in primary health care for alcohol problems. However, there is a need for screening and brief interventions with cross-cultural relevance for substances other than alcohol or tobacco,... such as cannabis, amphetamines, cocaine and opiates.
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was developed for the World Health Organization (WHO) by an international group of substance abuse researchers to detect and manage substance use and related problems in primary and general medical care settings. Primary health care professionals are well-positioned to provide interventions targeted to all substances irrespective of their legal status.
The ASSIST screening test version 3.0 is available in English and in 10 other languages (Arabic, Chinese, Farsi, French, German, Hindi, Portugüse, Russian, Spanish and Ukrainian).
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Menthol in tobacco products
WHO today published the new edition of its Model Lists of Essential Medicines and Essential Medicines for Children, which include new treatments for various cancers, insulin analogues and new oral medicines for diabetes, new medicines to assist people who want to stop smoking, and new antimicrobials... to treat serious bacterial and fungal infections.
The listings aim to address global health priorities, identifying the medicines that provide the greatest benefits, and which should be available and affordable for all. However, high prices for both new, patented medicines and older medicines, like insulin, continue to keep some essential medicines out of reach for many patients.
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Solomon Islands pharmacy staff have developed an essential medicines supplies list. It was a collaborative effort involving a lot of staff taking the pictures and putting it all together. The list was launched as an initiative to improve the availability of medical stock within the country
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
The key updates include: content update in various sections based on new evidence; design changes for enhanced usability; a streamlined and simplified clinical assessment that includes an algorithm for follow-up; inclusion of two new modules
- Essential Care and Practice that includes general guid...elines and Iminterventions and implementation module to support the proposed interventions by necessary infrastructure and resources; and, revised modules for Psychoses, Child and Adolescent Mental and Behavioural Disorders and Disorders due to Substance Use
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