An Indicator-based Approach - This manual presents an indicator-based approach for rapidly assessing pharmaceutical management systems and programs. The manual contains a set of 46 indicators of performance, grouped under eight topics of pharmaceutical management, with each topic being covered by a ...subset of indicators. Thirty-four of the indicators are quantitative, that is, expressed as numbers. Twelve are qualitative, in that they describe the presence or absence of a policy or management system, and in some cases, the degree of implementation.
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Global UNIDO Project: Strengthening the local production of essential generic drugs in the least developed and developing countries
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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First edition, November 1997 | Revised July 2002
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
Overcoming barriers in low- and middle-income countries
For the first time, this year’s report includes information on hepatitis C diagnostics. With a focus on selected countries with diverse HCV epidemics, the report provides updates on the various dimensions of access to HCV diagnostics and pha...rmaceutical products, including product pricing, the regulatory environment and patent status, which together shape the national hepatitis response in different settings. It highlights key areas for action by ministries of health and other government decision-makers, pharmaceutical manufacturers and technical partners.
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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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Drug Distribution and Control: Preparation and Handling–Guidelines
Review 2008
Drug Distribution and Control: Preparation and Handling
This Technical Assistance Bulletin is intended to assist pharmacists in the extemporaneous compounding of non-sterile drug products for individual patients. Included in this document is information on facilities and equipment, ingredient... selection, training, documentation and record keeping, stability and beyond-use dating, packaging and labeling, and limited batch compounding. This document is not intended for manufacturers or licensed repackagers.
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Global UNIDO Project: Strengthening the local production of essential medicines in least developed and developing countries