the importance of drug registration database in the ... · the importance of drug registration...

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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 amds@who.int

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Thank you!

http://www.who.int/hiv/amds/en/

http://apps.who.int/hiv/amds/patents_registration/drs/