Search Results for WHO

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WHO to Craft Essential Diagnostics List By Zachary Brennan - Published 16 June 2017

The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL).

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, WHO, Due Diligence, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: WHO essential diagnostics, EDL, Essential medicines list

Caribbean Regulatory System Begins Recommending Generic Drugs By Zachary Brennan - Published 14 June 2017

The Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) last month kicked off its work advising Caribbean countries’ governments by assessing and recommending four generic HIV treatments.

Categories: News, Latin America and Caribbean, FDA, WHO, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Caribbean medicines, Caribbean drug regulators, WHO, PAHO, Caribbean Regulatory System

WHO: Prequalified Drugs Made at Mylan's Nashik Site do not Raise Quality Concerns By Michael Mezher - Published 02 June 2017

The World Health Organization Prequalification Team (WHO-PQT) said this week that it is no longer concerned about the quality of prequalified products made at Mylan Pharmaceuticals' Nashik, India site after the US Food and Drug Administration (FDA) warned the site over quality system issues in April.

Categories: News, India, FDA, WHO, Drugs

Tags: WHO Prequalification, Mylan, Nashik

WHO Elects First African Director-General By Zachary Brennan - Published 23 May 2017

The World Health Organization (WHO) on Tuesday announced that Dr. Tedros Adhanom Ghebreyesus of Ethiopia has been elected by member states as the new Director-General of WHO.

Categories: News, Africa, WHO, Government affairs

Tags: Director-General WHO

WHO Officials Offer Opposition to Value-Based Drug Pricing By Zachary Brennan - Published 12 May 2017

World Health Organization (WHO) officials told press in a briefing on Thursday that the agency has serious reservations with value-based pharmaceutical pricing systems.

Categories: News, Asia, Canada, Europe, US, NICE, WHO, Biologics and biotechnology, Drugs, Government affairs

Tags: WHO on drug pricing, fair pricing forum, pharmaceutical pricing

WHO Prequalifies First Hepatitis C Diagnostic By Zachary Brennan - Published 05 December 2016

The World Health Organization (WHO) on Monday announced it has prequalified its first hepatitis C virus (HCV) rapid diagnostic test, which will help diagnose HCV in low- and middle-income countries and potentially improve access to treatment.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, WHO, Government affairs, In vitro diagnostics, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: WHO, prequalification, Gilead, Hepatitis C

WHO: New Emergencies Program Faces $200M Funding Gap By Michael Mezher - Published 31 October 2016

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.

Categories: News, WHO, Government affairs

Tags: WHO, World Health Organization, Health Emergencies Programme, WHE

WHO Seeks API Manufacturers for Prequalification Program By Zachary Brennan - Published 10 October 2016

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.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, ICH, WHO, Active pharmaceutical ingredients, Crisis management, Due Diligence, Government affairs, Manufacturing

Tags: WHO prequalification program, API manufacturing, ICH, regulatory authorities and WHO

WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable By Zachary Brennan - Published 30 September 2016

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.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, WHO, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: WHO, prequalification of vaccines, prequalification of medicines, WHO funds

FDA’s CBER to Forge Stronger Ties With WHO By Zachary Brennan - Published 01 June 2016

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.

Categories: News, US, CBER, Biologics and biotechnology, Due Diligence, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: vaccine prequalification, FDA and WHO, regulatory oversight, drug regulatory standards

WHO Releases Draft Medical Device Regulatory Framework By Michael Mezher - Published 24 May 2016

The World Health Organization (WHO) is seeking input on its newly developed regulatory framework for medical devices and in vitro diagnostics (IVDs).

Categories: News, WHO, In vitro diagnostics, Medical Devices, Regulatory strategy, Submission and registration

Tags: WHO, Medical Device Model Regulatory Framework,

WHO Pilot Project Speeds Approval of Janssen HIV Drug in 11 African Countries By Zachary Brennan - Published 19 February 2016

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).

Categories: News, Africa, WHO, Crisis management, Drugs, Government affairs, Regulatory strategy, Submission and registration

Tags: WHO, Johnson & Johnson, Africa drug approvals, African drug regulators

WHO Offers New Plan to Limit Drug Shortages By Zachary Brennan - Published 29 January 2016

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.

Categories: News, Asia, Europe, US, EC, EMA, FDA, WHO, Biologics and biotechnology, Crisis management, Drugs, Government affairs

Tags: WHO, drug shortages, injectable shortages, cancer drug shortages

WHO Calls for New Antivenom Treatments as Supplies Dwindle By Zachary Brennan - Published 04 December 2015

The World Health Organization (WHO) on Friday announced it's actively searching for new snake bite treatments as supplies of the most effective antivenom 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.

Categories: News, Africa, Asia, Middle East, US, WHO, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing, Regulatory intelligence

Tags: WHO, anti-venom, snake bite cures, MSF

EMA to Publish First Clinical Trial Reports in Mid-2016 Under New Transparency Law By Zachary Brennan - Published 22 September 2015

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.

Categories: News, Europe, EC, EMA, WHO, Biologics and biotechnology, Clinical, Compliance, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: EMA, trial transparency, WHO, European Commission, clinical trial data reports

WHO Raises Serious Concerns With Indian TB Drugmaker By Zachary Brennan - Published 04 September 2015

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.

Categories: News, India, WHO, Drugs, Ethics, Manufacturing

Tags: WHO, Notice of Concern, GMP, data integrity

African Union, WHO Team Up to Launch African CDC By Michael Mezher - Published 12 May 2015

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).

Categories: News, Africa

Tags: African CDC, WHO, African Union Commission, AUC

Global Efforts to Combat Antimicrobial Resistance 'Lacking,' WHO Report Finds By Michael Mezher - Published 29 April 2015

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.

Categories: News, WHO, Drugs

Tags: WHO, Antimicrobial Resistance, Antibiotics, AMR

Out of Africa: Six Regulatory Articles that Span the Continent By Janet Aker, Managing Editor, Regulatory Focus - Published 16 February 2015

Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southern Africa, West Africa, Central Africa, Northern Africa and South Africa. The articles contain the regulatory agency contacts/responsible parties for countries in each geographic area. The collection also includes an articles on RCOREs.

Categories: Features, Africa, Drugs, Government affairs, Project management, Submission and registration

Tags: Africa, South Africa, Northern Africa, North Africa, West Africa, Central Africa, East Africa, Southern Africa, RCOREs, regional centres of excellence, submission, submission and registration, dossier, regulatory submission, regulatory training, regulatory strategy, WHO, NEPAD, East African Community, EAC, regulatory challenges, harmonization, ministry of health, ministere de la sante

Australian Regulator Hits Restart on Plan to Name Biosimilars By Michael Mezher - Published 21 January 2015

Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has announced it will no longer implement a planned update to the way in which it names biosimilar products following a proposal by the World Health Organization to change a naming standard on which Australia relied for its policy.

Categories: News, Oceania, TGA, WHO, Biologics and biotechnology, Labeling

Tags: Biosimilars, INN, WHO, Naming, World Health Organization, Australian Biological Name, ABN, International Nonproprietary Names

Swiss Regulators Approve Ebola Vaccine Trial Meant to Protect Medical Volunteers By Louise Zornoza, RegLink News - Published 29 October 2014

Swiss healthcare product regulator Swissmedic has approved an application to start a clinical trial for an experimental Ebola vaccine at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, the regulator announced on 27 October 2014.

Categories: News, Europe, Clinical

Tags: Ebola, Swissmedic, World Health Organization, WHO

FDA, International Regulators Banding Together to Fight Ebola By Alexander Gaffney, RAC - Published 05 September 2014

Global regulators are banding together in the hopes of accelerating new therapies to treat a large and growing outbreak of the Ebola virus, a type of highly fatal hemorrhagic fever.

Categories: News, CFDA, EMA, FDA, MHLW, MHRA, PMDA, TGA, WHO

Tags: Ebola, ICMRA, WHO