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  • Regulatory NewsRegulatory News

    WHO: New Emergencies Program Faces $200M Funding Gap

    As part of its overall financing dialogue, the World Health Organization (WHO) gave an update on its newly formed Health Emergencies Programme (WHE), which the agency says is currently facing a $200 million funding gap. "For this biennium, we face a double challenge. You have asked us to do more, especially through the health emergencies programme," said WHO Director Margaret Chan in her opening remarks at the 2016 WHO financing dialogue in Geneva on Monday. According t...
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    WHO Seeks API Manufacturers for Prequalification Program

    The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and treatment of HIV/AIDS, hepatitis B and C, tuberculosis, malaria, neglected tropical diseases, influenza, diarrhea and support reproductive health. WHO invites manufacturers of selected APIs to submit Expressions of Interest (EOIs) for API evaluation and says the ultimate aim of...
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    WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable

    The World Health Organization (WHO), industry groups and other partners on Friday announced a new financing arrangement that will add $20 million annually in new industry fees to ensure the financial sustainability and quality of WHO’s prequalification program. The new fees will also include the setting (and public disclosure) of quantitative performance targets. Indicators and performance targets will relate to review time for full assessment, review time for abbreviate...
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    FDA’s CBER to Forge Stronger Ties With WHO

    The US Food and Drug Administration (FDA) on Tuesday announced it’s forging a cooperative agreement with the World Health Organization (WHO) to support further regulatory systems strengthening, development of new norms and standards and research to advance global access to safe and effective biologics that meet international standards. FDA's Center for Biologics Evaluation and Research (CBER) anticipates providing up to $2 million in FY 2016 to support the project, as w...
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    WHO Releases Draft Medical Device Regulatory Framework

    The World Health Organization (WHO) is seeking input on its newly developed regulatory framework for medical devices and in vitro diagnostics (IVDs). The framework, which establishes a common global model for regulating devices and IVDs and provides countries with a two-phased path to implementation, was released for public comment in May. WHO began its work developing the framework in 2015 after the World Health Assembly (WHA) adopted Resolution WHA67.20 ,...
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    WHO Pilot Project Speeds Approval of Janssen HIV Drug in 11 African Countries

    A World Health Organization (WHO) pilot project looking to bring already-approved drugs to Africa more quickly will continue into 2016 after four of 11 participating African national medicines regulatory authorities (NMRAs) approved Janssen’s pediatric HIV drug Intellence (etravirine). As of November, regulators from Namibia (approved 86 days after submission), Cote d’Ivoire (four months), Botswana (six months) and Kenya (seven months) have approved the use of the drug, ...
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    WHO Offers New Plan to Limit Drug Shortages

    The World Health Organization (WHO) released a new report this week on ways to address global drug shortages, which are increasing in frequency, particularly for old, off-patent or difficult to formulate treatments. Difficulties in acquiring raw materials, manufacturing problems, barriers to competition, business decisions, the impact of new technologies, expensive medicines and fragmented markets were all listed as reasons for new drug shortages based on studies in seve...
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    WHO Calls for New Antivenom Treatments as Supplies Dwindle

    The World Health Organization (WHO) on Friday announced it's actively searching for new snake bite treatments as supplies of the most effective anti-venom treatment are due to run out in 2016. Companies can now apply, with no submission fees, to have new treatments assessed by WHO beginning in March. About five million people are bitten by snakes every year, causing upward of 125,000 deaths and leaving 400,000 people permanently disabled or disfigured, according to the W...
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    EMA to Publish First Clinical Trial Reports in Mid-2016 Under New Transparency Law

    Following two meetings with drug companies and other stakeholders in July and September, the European Medicines Agency (EMA) says it will publish the first clinical trial reports in mid-2016. The release of the reports comes as EMA's policy on publishing the data came into effect last January. The new policy applies to clinical reports contained in all marketing-authorization applications submitted on or after 1 January 2015, and includes reports where drugmakers hav...
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    WHO Raises Serious Concerns With Indian TB Drugmaker

    World Health Organization (WHO) inspectors earlier this week released a letter uncovering a number of safety issues at a Mumbai-based manufacturer of tuberculosis drugs. WHO said its inspection at the facility of Svizera Labs, which is part of Maneesh Pharmaceuticals, from June 2015 uncovered several critical and major deviations from WHO Good Manufacturing Practice standards and this latest Notice of Concern letter includes deficiencies that are still a problem for the ...
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    African Union, WHO Team Up to Launch African CDC

    Officials at the African Union Commission (AUC) and the World Health Organization Regional Office for Africa (WHO/AFRO) are looking to address the shortcomings of the international response to the Ebola crisis by launching a new disease monitoring agency, the Centres for Disease Control and Prevention in Africa (African CDC). Background Africa has the world's highest burden of disease , with far higher mortality rates for infectious diseases than any other region. Many...
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    Global Efforts to Combat Antimicrobial Resistance 'Lacking,' WHO Report Finds

    The World Health Organization (WHO) has completed the first global assessment of national strategies to counter the rise of antimicrobial resistance (AMR). Only a quarter to countries had plans in place to limit the use of antimicrobials, leaving "major gaps" in the struggle against AMR in every region of the world. Background The rise of AMR is tied to the overuse and misuse of antimicrobial medicines such as antibiotics. When microbes targeted by antimicrobial medicin...