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Development of workshops and trainings concerning „Pharmaceutical approvals in Nepal“

When you get prescribed medicines, you certainly expect effective, high-quality and save medicines. But who decides, which medicines come into the market and who controlls the criteria?


In most countries worldwide these duties are taken over by national authorities. In Germany it is called „Bundesinstitut für Arzneimittel und Medizinprodukte“ (BfArM, in english: Federal Institut for pharmaceuticals and medical devices). In the United States it is the Food and Drug Administration (FDA). These authorities register new pharmaceuticals and evaluate whether they are suitable for the market by the producer’s documents.


When a product meets safety-, effectiveness- and quality requirements, it is licensed. That way the population is protected from low-grade medicines. Since a short period of time there are intentions on meshing licensing procedures of different countries so that it is easier for pharmaceutical producers to license their products in several countries and to gain a constant quality of the medicines.


As a Medical Aid Organization action medeor set a target not only to deliver high-quality pharmaceuticals, but also to improve and support local health care structures in the affected countries. Only a mature licensing system for pharmaceuticals protects the population sufficiently from low-grade and ineffective medicines. On this account, action medeor supports the Department of Drug Administraion (DDA) in Nepal in adapting their licensing system to international standards. With the help of workshops und trainings, local drugmakers learn how a pharmaceutical licensing system works, how to generate approval documents for the produced products and how the pharmaceutical right in Nepal works.

Projectinformation:

Target:
Development of workshops and trainings concerning „Pharmaceutical approvals in Nepal“
Projectarea:
Nepal
Term of validity:
Juni - November 2018
Projectvolume:
7.000
Sponsor:
PTB



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