Capability and Performance
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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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.
J Nepal Health Res Counc 2013 May;11(24):198-204
DRUGS REGULATORY UNIT | NOVEMBER 2009 | SECOND EDITION
Department of Behavioural Medicine, Lagos State University College of Medicine Ikeja, Lagos Nigeria
Global Mental Health (2015), 2, e5, page 1 of 12. doi:10.1017/gmh.2015.8;
Received 29 January 2015; Revised 8 April 2015; Accepted 15 April 2015
The infectious disease burden in India is among the highest in the world. A large amount of antibiot-ics are consumed in fighting infections, some of them saving lives, but every use adding to antibiotic resistance in bacteria. Antibiotic use is increasing steadily (table 1), particularly ... certain antibiotic classes (beta-lactam antibacterials), most notably in the more prosperous states. Resistance follows in lock-step.
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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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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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2014-2020, Draft March 2014