WHO regulatory and prequalification activities to remain at HQ
Following an independent evaluation of the proposed relocation of the Prequalification programme and other regulatory activities, the WHO Director General decided that these core WHO functions would remain at headquarters in Geneva.
WHO publishes Emergency Use Listing procedure and roadmap to make new medical products more readily available during health emergencies
WHO today published the Emergency Use Listing (EUL) procedure to streamline the process by which new or unlicensed products can be used during public health emergencies. The EUL replaces the Emergency Use Assessment and Listing (EUAL) procedure, which was used during the West Africa Ebola outbreak of 2014-2016.
#MedSafetyWeek is an international social media campaign organized every year by the Uppsala Monitoring Centre to raise awareness of ADRs and national reporting systems. This year, the campaign takes place from 25-29 November and its theme of polypharmacy – which means taking many medicines.
WHO launches first-ever insulin prequalification programme to expand access to life-saving treatment for diabetes
13 November 2019 - The World Health Organization (WHO) today announced the start of a pilot programme to prequalify human insulin to increase treatment for diabetes in low- and middle-income countries.
WHO prequalifies Ebola vaccine, paving the way for its use in high-risk countries
12 November 2019 - The World Health Organization (WHO) today prequalified an Ebola vaccine for the first time, a critical step that will help speed up its licensing, access and roll-out in countries most at risk of Ebola outbreaks. This is the fastest vaccine prequalification process ever conducted by WHO.
Move of vector control products evaluation to Prequalification team is now finalized and official
Pesticides used in vector control were one of the first product types evaluated by WHO. The WHO Programme for the Evaluation and Testing of New Insecticides was established as part of the Intensified Medical Research Programme, whose plan was approved in principle by the World Health Assembly in 1959.
WHO signs MoU with International Generic and Biosimilar Medicines Association to promote access
Full access to medicines is hampered by a variety of factors. Two important barriers are high prices and regulatory issues such as long lag times in bringing medicines to market.
To address these issues, Dr Tedros Adhanom Ghebreyesus, WHO Director-General, and Jim Keon, Chair of the International Generic and Biosimilar Medicines Association, today signed a memorandum of understanding.
1 October 2019 - WHO today launches the School of INN (International Non-proprietary Names). INNs are global names for medicines. They provide one reference generic name for each individual medicine that comes to market. Since 1953, the World Health Organization has named over 10 000 medicines.
WHO releases the 2019 AWaRe Classification Antibiotics
1 October 2019 – The 2019 WHO AWaRe Classification Database was developed on the recommendation of the WHO Expert Committee on Selection and Use of Essential Medicines. It includes details of 180 antibiotics classified as Access, Watch or Reserve, their pharmacological classes, Anatomical Therapeutic Chemical (ATC) codes and WHO Essential Medicines List status. It is intended to be used as an interactive tool for countries to better support antibiotic monitoring and optimal use.
WHO convenes global stakeholders to improve access to assistive technology
On 22 and 23 August WHO will hold a global consultation on assistive technology to gauge global demand and supply, bottlenecks to access and ways to improve the availability of quality-assured, affordable assistive products for everyone who needs them.
WHO issues new recommendation on antivenom for snakebites
The World Health Organization (WHO) has responded proactively to concerns about the low availability of safe, effective antivenom immunoglobulin products for the Sub-Saharan African region by establishing a risk-benefit assessment process to screen antivenom products intended for marketing in Sub-Saharan Africa. The risk benefit assessment followed the WHO assessment and listing of snake antivenoms.
New Essential Medicines and Diagnostics Lists published today
WHO China / Beijing Fotolink Technology Development Co., Ltd
WHO’s Essential Medicines List and List of Essential Diagnostics are core guidance documents that help countries prioritize critical health products that should be widely available and affordable throughout health systems.
Published today, the two lists focus on cancer and other global health challenges, with an emphasis on effective solutions, smart prioritization, and optimal access for patients.
WHO launches five-year plan to improve the quality and safety of health products
Today, WHO is releasing a five-year plan to improve the quality and safety of medicines in countries and globally.
‘Delivering Quality-assured Medical Products for All 2019–2023’ will be presented to donors and partners (Bill and Melinda Gates Foundation, UNITAID, The Global Fund to Fight AIDS, TB and Malaria, GAVI and UNICEF), all of whom have contributed to the strategic objectives and supported WHO’s work on health products regulation over the years...
Webinar on June 4th, 2019: Tackling the world drug problem - a focus on opioids
The WHO Cluster of Access to Medicines, Vaccines and Pharmaceuticals (MVP) is hosting a webinar on June 4th, 2019 entitled: Tackling the world drug problem - a focus on opioids. This webinar will address the work carried out by WHO’s Expert Committee on Drug Dependence in preventing and mitigating harm caused by non-medical use of opioids, while ensuring that opioids with therapeutic use are accessible to those who need them. Presentations by Dr. Gilles Forte, Professor Jason White, Professor Bruna Brands and Dr. Pamela Kaduri.
Please register here for the morning session (10.00-11.00 CEST) or the afternoon session (16.00-17.00 CEST).
Hands-on learning or refreshing with WHO
From April to early August last year I was attached to the Regulatory System Strengthening team at WHO as a rotational fellow. As part of this experience, I had the opportunity to participate in a WHO inspection of a vaccine manufacturing facility in South Korea with two of WHO's experienced inspectors, Mustapha and Vimal.
First in vitro diagnostic prequalified through the alternative performance evaluation mechanism
18 April 2019 - For the first time, WHO has just prequalified an HIV diagnostic test through the independent performance evaluation mechanism. The mechanism was introduced to streamline assessment timelines in order to make health products more readily available and enables WHO to verify aspects of a diagnostic that are considered essential for use in resource-limited settings.
The first diagnostic prequalified through this new procedure is called m-PIMA HIV-1/2 VL and is produced by Alere Technologies GmbH.
New WHO advice on biosimilar medicines aims to increase access to quality treatment
22 March 2019 – A new WHO Q&A supplements existing guidelines for the regulatory evaluation of biosimilar products. The document has been adopted by the WHO Expert Committee on Biological Standardization. The Q&A serves to clarify guiding principles included in the Guidelines on similar biotherapeutic products and on similar monoclonal antibodies.
Taken together, these three documents provide up-to-date guidance on evaluation of biosimilar products. Biosimilars provide additional and more affordable treatment options to patients. WHO’s role is to support countries in efforts to provide affordable quality-assured treatments to their populations.
12 April 2019 - The World Health Organization (WHO) is supporting the acceleration of new Ebola interventions in Africa, in particular the development of additional candidate vaccines. The Strategic Advisory Group of Experts (SAGE) on Immunization previously recommended that urgent consideration should be given to evaluating new candidate vaccines in randomised trials among health care and front line workers in high risk areas which are not directly related to a case of Ebola (ie, in areas the outbreak has not reached). As part of these efforts, WHO has been working with several partners to discuss study designs that could help assess the efficacy and effectiveness of available candidate vaccines.
UN endorses WHO advice on strict controls of dangerous fentanyls
3 April 2019 - The Commission on Narcotic Drugs voted on 19 March, 2019 to adopt recommendations from the WHO Expert Committee on Drug Dependence (ECDD) to bring nine New Psychoactive Substances under international control. The Commission also decided to defer its vote on the WHO’s recommendations to lower international control of cannabis-related substances to a later time.
WHO endorses decisions of Expert Committee on cannabis and other substances
On 12-16 November 2018 the WHO Expert Committee on Drug Dependence (ECDD) met in Geneva to conclude its review of cannabis and cannabis related substances. This was the first time that the ECDD carried out a full review of these substances since the International Drug Control Conventions were established in 1961 and 1971. Other substances under review were fentanyl derivatives, tramadol and pregabalin.
Tanzania is first African country to reach an important milestone in the regulation of medicines
Tanzania is the first confirmed country in Africa to achieve a well-functioning, regulatory system for medical products according to the World Health Organization (WHO). This means that the Tanzania Food and Drug authority (TFDA) has made considerable improvements in recent years in ensuring medicines in the healthcare system are of good quality, safe and produce the intended health benefit...
In lead-up to World AIDS Day, WHO prequalifies second HIV self-test
People living with HIV may be put off being tested due to stigma, lack of confidentiality or long distances to testing centres. Self-testing has the potential to circumvent these constraints.
This is why WHO’s prequalification of a second HIV self-test this week could potentially help ramp up diagnosis and treatment for people living with the virus (OraQuick was the first self-test to receive WHO prequalification, in 2017).
Tanzania is first African country to reach an important milestone in the regulation of medicines
WHO / TM
10 December 2018 - Tanzania is the first confirmed country in Africa to achieve a well-functioning, regulatory system for medical products according to the World Health Organization (WHO). This means that the Tanzania Food and Drug authority (TFDA) has made considerable improvements in recent years in ensuring medicines in the healthcare system are of good quality, safe and produce the intended health benefit.
New FDA-WHO joint pilot to accelerate access to HIV medicines
30 November 2018 - The U.S. Food and Drug Administration (FDA) and WHO have launched a joint pilot initiative to speed up approval of HIV medicines for supply to developing countries.
The FDA will share documents on HIV drug applications that have been approved or tentatively approved by the agency under the US President’s Emergency Plan for AIDS Relief (PEPFAR).
WHO Expert Committee on Drug Dependence meets to review cannabis and other substances
On 12-16 November the WHO ECDD will meet in Geneva to conclude its review of cannabis and cannabis related substances. This is the first time that the ECDD carries out a full review of cannabis and cannabis-related substances since the International Drug Control Conventions were established in 1961 and 1971. Until now, cannabis has been under the strictest control (schedules 1 and 4) – i.e. at the same level as heroin.
02 November 2018 - Over the past 20 years, new vaccines and medicines have begun to reach people in the world’s poorest and most remote communities. Thanks to dedicated funding for research, there is a healthy pipeline of new products – like the Meningitis A vaccine – that have been created specifically to meet the greatest health needs of people in developing countries.
On 25 September, WHO prequalified Rotasil, an oral rotavirus vaccine produced by Serum Institute of India. Rotasil is the first Rotavirus vaccine with heat stable characteristics, which makes it particularly suitable for use in low-income countries, where weak infrastructure and frequent lack of electricity make refrigeration very difficult.
WHO invites laboratories to participate in WHO External Quality Assurance Assessment Scheme
Quality control (QC) testing is complex, and errors are costly and may jeopardize patient safety. Given these high stakes, trust in a QC laboratory’s capabilities is essential for all stakeholders who request its services.
News briefing: 40th WHO Expert Committee on Drug Dependence (ECDD)
The 40th WHO Expert Committee on Drug Dependence (ECDD) met from 4-7th June in a specially convened session to evaluate the public health harms and therapeutic value of cannabis and its related substances.
24 JULY 2018 - 1 of every 7 people today lives with some form of disability, and the number is growing.
Whether in rich or poor societies, whether due to old age, an accident, acquired or by birth, no one with disability should be denied the right to health, education, livelihood, participation and inclusion.
New WHO report reviews medicines reimbursement policies to ensure equitable access in Europe
The new WHO report “Medicines reimbursement policies in Europe” examines the various policies that increase access to affordable medicines. Based on direct data collection from 45 of the 53 countries in the WHO European Region...
Presentation by Sana Hafeez, WHO Champion for assistive products
I would like first to share with you all a story of a young outstanding and brilliant girl, who always scored more than 90% in her school, a topper of the secondary board exam, a distinction holder in Medical school, who walked in the medical school with a big dream of becoming a plastic surgeon, but on the graduation day, she had to propel her wheelchair to the stage, wearing orthoses to support her legs to receive her degree… and that young graduate was none other than me … Dr. Sana Hafeez.
Request for Proposals: Scoping review and report on national policies, legislative and regulatory approaches for the supply, prescribing and use of antimicrobials
03 May 2018 The WHO Department of Essential Medicines and Health Products is seeking proposals for the above mentioned scoping review and report, to support the development of strategies and tools and thereby provide practical guidance for country implementation of the AWaRe categorization of antibiotics on National Essential Medicines Lists and into medicines regulations and policies.
WHO recommendations endorsed by 61st UN Commission on Narcotic Drugs in Vienna
14 March 2018 On 14 March, the UN Commission on Narcotic Drugs (CND) unanimously endorsed WHO recommendations to place 12 New Psychoactive Substances (NPS) under international control. NPS are synthetic substances that produce similar effects to illegal drugs (like cocaine or ecstasy).
03 JANUARY 2018 - At the end of December 2017, WHO prequalified the first conjugate vaccine for typhoid, Bharat Biotech’s Typbar-TCV®. Typhoid conjugate vaccines (TCVs) are innovative products that have longer-lasting immunity than older vaccines, require fewer doses, and can be given to young children through routine childhood immunization programs.