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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Globalization and Health201612:63; DOI: 10.1186/s12992-016-0195-3
The Zimbabwe National Pharmacovigilance Policy Handbook, 2nd Edition updates the November 2013 version to indicate the Zimbabwe National Pharmacovigilance (PV) Centre’s compliance with the WHO Pharmacovigilance Indicators Handbook 2015.
Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
The use of Delamanid and Bedaquiline for Children with Drug-Resistant Tuberculosis.
A survival guide for clinicans.
3rd edition.
Public health Panoram, Vol.2 Issue 1 March 2016