PQDx 0144-043-00 WHO
PQDx Public Report
November/2016, version 4.0
PQDx 0214-064-00
WHO PQDx PR
April/2016, version 3.0
There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regi...men characteristics corresponding to the needs of end-users.
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Standard Treatment Guideline
Research Article
PLOS ONE | DOI:10.1371/journal.pone.0164619 October 13, 2016
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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Technical Report
AIDS Medicines and diagnostics service
September 2016
Standard Treatment Guideline
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 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.