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The importance of drug registration
database in the strategic planning and
access to antiretroviral (ARV)
Boniface Dongmo Nguimfack
HIV/Technology and Commodities
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What is AMDS
The AMDS is a network of technical partner organisations that work to support countries in procurement and supply management of HIV commodities. The secretariat of this network is housed in WHO/HIV Department.
The AMDS operates as a clearing house, collecting and disseminating strategic information: Prices, availability and regulatory status of ARVs, technical information of HIV diagnostics and other HIV-related health supplies (http://www.who.int/hiv/amds/en/)
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Drug Regulatory Database
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Objectives
Promote access to life saving medicines
Work with all concerned parties to remove or minimize obstacles and barriers for medicines entering the market and facilitate their uptake
Provide partners and players in the field of SCM with reliable data to inform their decision making process
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Who should provide us with data
Manufacturer producing Prequalified and stringent
regulatory approved medicines (HIV, TB and ACTs)
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WHY
Limited access to information on ARV marketing authorizations by countries
Inform stakeholders and WHO management team in their process of making strategic decision and advocacy
Inform the guideline committee on the status of drugs that are/will be included/recommended in guidelines
Inform/made available to state and non state procurement officers, donation programmes, countries using the GFATM grant (options A and B) the list of medicines registered in their respective country
Facilitate the procurement of this drugs
Understand some of the market drivers and procurement behavior
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How
Collect regulatory information and make it available in the public domain as
Registered
Expired
Expiry date not available
Under registration renewal
Contributors: all R&D and generic ARV producers and AMDS partners (SCMS, UNICEF, MissionPharma)
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How does the database look like
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What Next?
User guide
Expansion of the database to cover TB and Malaria medicines
Living database
Update when information becomes available
Companies to send their information to [email protected]
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Thank you!
http://www.who.int/hiv/amds/en/
http://apps.who.int/hiv/amds/patents_registration/drs/