World Drug Report 2018
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The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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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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Report: A survey conducted among the 27 high MDR-TB burden countries.
March – July 2015
Stop TB Partnership in collaboration with Medecins Sans Frontieres (MSF).
Accessed November 2017.
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
The Federal Ministry of Health (FMOH) has been coordinating sector wide reforms that aim to improve equity and quality of health services. It is widely known that; the sector is growing in line the overall growth and transformation plan of the country and the sector is bein...g guided by the health sector transformation plan (HSTP). As part of these efforts, to achieve the targets set, the sector identified information revolution as one of the transformational agendas. In the meantime, Appropriate and timely use of health and health-related information is an essential element in the process of transforming the health sector.
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FDA’s compounding program aims to protect patients from unsafe, ineffective and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them. Here you can find informations to laws &policies, compliance action, ....
Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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The guideline on Drug misuse: opioid detoxification, commissioned by NICE and developed by the National Collaborating Centre for Mental Health, sets out clear, evidence-based recommendations for healthcare staff on how to work with people who misuse opioids to significantly improve their treatment a...nd care, and to deliver detoxification safely and effectively. Of the estimated 4 million people in the UK who use illicit drugs each year, approximately 50,000 misuse opioids (such as heroin, opium, morphine, codeine and methadone). Opioid misuse presents a considerable health risk and can lead to significant social problems. This NICE guideline is an important tool in helping people to overcome their drug problem.
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Countries, partners, and donors are committed to
the global elimination of blinding trachoma by 2020.
Achieving this public health milestone requires more
than funding; it requires health personnel with the
right mix of skills, and well supported and managed
health systems. Mass drug administra...tion (MDA)
with Zithromax®, the Pfizer, Inc. donated antibiotic,
is a key component of the SAFE strategy, endorsed
by the World Health Organization. There is growing
recognition that improving all aspects of MDA, from
planning to training, recording to reporting, and
receipt of drug to distribution (the supply chain), will
be necessary if MDA programmes are going to reduce
the community burden of Chlamydia trachomatis, and
eliminate trachoma as a cause of blindness by 2020.
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