Home > News


New interim definition of stringent regulatory authority - 6/21/2017

The WHO has just published the 51st Technical Report of the Expert Committee on Specifications for Pharmaceutical Preparations, which includes a new (interim) “definition of Stringent Regulatory Authority (SRA)”

WHO Regulatory Framework for Medical Devices - 5/11/2017

The WHO has just published the WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices, which was adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2016, and will be published as Annex 4 to its next report. It is available at http://www.who.int/medical_devices/publications/global_model_regulatory_framework_meddev/en/

An original research paper from QUAMED - 4/11/2017

In a paper recently published in the BMJ Global Health, which may be accessed at http://gh.bmj.com/content/2/2/e000172, we evaluated the compliance of a sample of pharmaceutical distributors active in sub-Saharan with the standards of the WHO guideline ‘Model Quality Assurance System (WHO MQAS) for procurement agencies’.

Falsified and Sub-standard Medicines: Danger of Death - 1/16/2017

Jacques Pinel († 2015), who passed away in August 2015, was a pioneer in the fight for universal access to quality-assured medicines.

Guide to Global Fund policies on procurement and supply management of health products - 1/3/2017

www.theglobalfund.org/.../PSM_ProcurementSupplyManagement_ Guidelines_en/

Two more papers on poor-quality antimalarials. - 11/25/2016

Two more papers on poor-quality antimalarials are available at https://malariajournal.biomedcentral.com/articles/10.1186/s12936-016-1096-x and at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0125577

QUAMED at ASTMH 2016 - 11/16/2016

QUAMED is present at the Conference of the American Conference of Tropical Medicine and Health in Atlanta.

The quality of ACT in Ghana and implications for Public Health - 11/11/2016

The BMC Phamacology and Toxicology recently published the results of a field survey conducted to assess the quality of ACTs in the central part of Ghana.

Fighting poor-quality medicines in LMICs. The importance of advocacy and pedagogy - 11/11/2016

This paper gives an updated overview of the state of the art concerning quality of medicines in low- and middle-income countries and makes a call for evidence-based advocacy translating technical concepts in lay language; https://joppp.biomedcentral.com/articles/10.1186/s40545-016-0088-0

QUAMED at FIP World Congress - 11/2/2016

From 28 August to 1 September 2016, a QUAMED representative attended the 76th edition of the FIP World Congress of Pharmacy and Pharmaceutical Sciences in Buenos Aires, Argentina (http://buenosaires2016.fip.org/home), for raising awareness about the challenges to ensure quality of medicines in low- and middle-income countries)....

Short video on quality of medicines - 10/3/2016

Video developed by quamed on quality of medicines

Predictable threats to public health through delaying universal access to innovative medicines for Hepatitis C: A pharmaceutical standpoint - 9/29/2016

Predictable threats to public health through delaying universal access to innovative medicines for Hepatitis C

Antimicrobial resistance: the threat of poor-quality medicines - 6/14/2016

http://www.bmj.com/content/353/bmj.i3087/rr-3 Read more on the link between poor-quality medicines and antimicrobial resistance

50th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - 6/7/2016

The WHO has just published the 50th report of the Expert Committee on Specifications for Pharmaceutical Preparations (WHO Technical Report Series, No. 996).

Wambo.org - 5/31/2016

In a press release issued on 25 May 2016, the Global Fund announced the launch of wambo.org, a tool that provides up-to-date information on available products, prices, expected delivery time and tracking.

76th FIP World Congress of Pharmacy and Pharmaceutical Sciences 2016 - 5/16/2016

QUAMED will be present at the 76th FIP World Congress of Pharmacy and Pharmaceutical Sciences 2016, to be held in Buenos Aires, Argentina from 28th August to 1st September 2016.

Quality of antimicrobials in China - 4/20/2016

In a letter to the Lancet Global Health, Hui Pan and colleagues report on a cross-sectional study that independently investigated the content in active pharmaceutical ingredient of five common antimicrobial drugs in Shantou southern China

Counterfeited medicines in Peru - 4/5/2016


Falsified generic Daclatasvir found in Myanmar - 2/24/2016

Unfortunately, the lack of access to new medicines for treating hepatitis C is creating room for illicit market and counterfeiters.

Falsified phenobarbital - 2/23/2016

In a letter to the Lancet Neurology, Otte and colleagues report about documented cases of counterfeited phenobarbital.

US FDA issues a warning letter to the Indian company IPCA, because of GMP violations - 2/23/2016

On 29/01/2016, theUS FDA published a warning letter sent to the Indian company IPCA Laboratories Ltd, concerning the inspections conducted in 2014 at 3 of its manufacturing sites.

Indian manufacturer of sterile products receives US FDA Warning Letter and changes name from Marck Biosciences to Amanta Healthcare - 8/21/2014

Following an inspection in March 2014 of Marck Biosciences Limited, the US FDA published an Import Alert and a Warning Letter.

The ICH accepts two new members - 7/31/2014

In June 2014, two new members joined the ICH: the Swiss regulatory authority, Swissmedic, and the Canadian regulatory author (Health Canada).

Japan and Korea are now member of PICs - 7/31/2014

Japan and Korea became members on the 1st of July 2014.

First GDP non-compliance report published by EU authorities - 5/20/2014

A few months ago, the scope of EudraGMP was extended to include GMP Non-Compliance Reports, and very recently also GDP Non-Compliance Reports.

8th European Congress on Tropical Medicine and International Health - 8/8/2013

QUAMED will participate in a session entitled "MDG agenda post 2015: drugs, cure or curse?" on September 10.

The global impact of Indian generics on access to health - 5/6/2013

Publication of an article in the Indian Journal of Medical Ethics.

Fake drugs in East Africa - 1/30/2013

As fake medicines flood the market in East African countries, patients turn to traditional medicine.

UPDATE : Training in Kinshasa - 12/3/2012

Feedback on the training in quality assurance in Kinshasa.

BMJ: International action needed to ensure the quality of medicines - 11/19/2012

The British Medical Journal (BMJ) published on 13/11/13 a paper advocating for a global treaty to tackle the deadly trade of substandard and fake medicines. The main paper is accompanied by a commentary co-authored by two members of the Quamed Steering Committee. You can read the papers and the BMJ press release at: http://www.bmj.com/content/345/bmj.e7518 http://www.bmj.com/content/345/bmj.e7381 http://www.bmj.com/press-releases/2012/11/13/international-action-needed-ensure-quality-medicines-and-tackle-fake-drugs

Article about QUAMED in "Le Soir" - 10/25/2012

"Le soir" interviewd QUAMED and wrote a whole page about the problem of the quality of medicines in developping countries.

New QUAMED leaflet - 10/16/2012

A new leaflet is available (for the ECHO program).

Training in Kinshasa - 10/16/2012

Training workshop in Kinshasa (QUAMED/USAID/BTC)

A case of fake artesunate in an European traveller - 10/5/2012

The Lancet recently reported the case of a Spanish traveller who received fake artesunate to treat a malaria episode (Lancet 2012; 380: 1120). The 28-year woman, who had bought artesunate and sulfadoxine-pyrimethamine on the local market in Equatorial Guinea, eventually recovered after receiving genuine treatment, while the analyses conducted at the The London School of Hygiene & Tropical Medicine confirmed the counterfeit nature of artesunate. This episode helps to ring once more the bell about the risks posed to the patients by insufficient regulatory enforcement in low-income countries.

Poor-quality medical products: time to address substandards - 9/10/2012

The rapid globalization of the pharmaceutical market has led to a situation of multiple standards: the quality of medicines is not uniform, but depends on the level of income and regulation in the country of destination. While various initiatives have been launched to fight the illegal counterfeits, substandards medicines (which are, conversely, authorized by National Regulatory Authorities (NRAs)), remain poorly or not addressed. However, they represent a widespread problem, highly prevalent in resource-poor settings and at least as dangerous as counterfeits. Noteworthy, similar concerns exist for in vitro diagnostics and medical devices. The existing definitions do not facilitate the fight against substandards, and they could even lead to a normative framework that de facto accepts the possibility of inadequate standards in countries with underresourced NMRAs, enabling many manufacturers to sell poor quality medicines with no risk to be sanctioned. The 65th World Health Assembly approved a resolution on a new intergovernmental mechanism for international collaboration on "substandard, spurious, falsely-labelled, falsified or counterfeit medical products". It is hoped that it will tackle the problem of poor-quality medical products from a more comprehensive and patient-centered approach, aimed at preventing all of them, irrespectively of whether substandards or counterfeits. You can read more in an Editorial recently published in Tropical Medicine International Health: Raffaella M. Ravinetto, Marleen Boelaert, Jan Jacobs, Corinne Pouget and Christophe Luyckx. Poor-quality medical products: time to address substandards, not only counterfeits. TMIH doi:10.1111/j.1365-3156.2012.03076.x

US FDA inspection database - 9/3/2012

The US Food and Drug Administration is publicly disclosing inspections’ information, to help improve the public’s understanding of how it works. Disclosure of the compliance status of pharmaceutical firms may also help to inform public and purchasers’ decision-making, allowing them to make more informed choices. You can access the database at: http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm and http://www.accessdata.fda.gov/scripts/inspsearch/

More than 150 generic products tentatively approved by the US FDA - 7/24/2012

In May 2004, in support of the President’s Emergency Plan for AIDS Relief (PEPFAR), the US FDA announced an initiative to assess applications for single entity, fixed dose combination and co-packaged versions of previously approved antiretroviral therapies - even if there was still patent or exclusivity market protection for the product in the U.S. Thanks to this expedite review process, the agency has up to now approved or tentatively approved a total of 152 antiretroviral drugs. The most recent FDA tentative approvals concern the following generic drugs: - abacavir oral solution (Hetero Labs Ltd. Unit III, July 2, 2012) - lopinavir and ritonavir oral solution (Cipla Ltd., June 29, 2012) - efavirenz tablets (Edict Pharmaceuticals Private Ltd., June 25, 2012 and Micro Labs Ltd., June 20, 2012) “Tentative approval” means that the FDA has found that these generic product has met all required manufacturing quality, clinical safety, and efficacy requirements, even if they cannot be marketed yet in the U.S. because of existing patents and/or marketing exclusivity. The complete list is available in: http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm?source=govdelivery

An article on the WHO Prequalification Programme - 7/9/2012

The second 2012 issue of the WHO Drug Information features an article on the WHO Prequalification of Medicines Programme (PQ). Since 2009, the PQ hosts a quality risk assessment mechanism on behalf of the Global Fund: the Expert Review Panel (ERP), which assesses the quality risks of pharmaceutical products which do not yet meet stringent quality requirements. This process has promoted progression of many medicines to prequalification: of 115 products assessed by the ERP in 2009 and 2010, 44 went on to become prequalified or approved by a stringent regulatory authority. You can download this issue of the WHO Drug Information at http://www.who.int/medicines/publications/druginformation/issues/26-2.pdf

The WHO Prequalification of Quality Control Laboratories - 6/28/2012

On 21/06/2012, there was a new addition to the List of Prequalified Quality Control Laboratories (the Republican Control and Analytical Laboratory of the Centre for Expertise and Testing in Health Care - BELARUS). This is a good opportunity to remind the importance of the WHO List of Prequalified Quality Control Laboratories, which is periodically updated and can be downloaded at http://apps.who.int/prequal/ and http://apps.who.int/prequal/lists/PQ_QCLabsList.pdf

Quality of Medicines in DCs: an informal selection of scientific literature - 6/18/2012

Quality of Medicines in DCs: an informal selection of scientific literature, updated by R Ravinetto on 18 June 2012. The PDF version is avaialble on request

The Antimalarial Quality Surveyor of WWARN - 6/11/2012

WWARN (Worldwide antimalarial resistance network) has recently created the Antimalarial Quality Surveyor, a visualization tool delivering customized summaries of published reports of antimalarial medicine quality, displaying geographical distribution across regions and over time. It enables studies to be filtered according to medicine, report type, collection type, medicine source and quality classification. You can find it at the WWARN website: http://www.wwarn.org/aqsurveyor/

A poor-quality medicine for the treatment of visceral leishmaniasis - 6/4/2012

The medical journal “Plos Neglected Tropical Diseases” published on 29th April 2012 a paper describing an outstanding case of poor-quality medicine: Bangladeshi patients with visceral leishmaniasis received a product that should have contained miltefosine, but that actually contained no active ingredient at all. Retrospectively, it will be probably impossible to accurately estimate the exact extent of the morbidity and mortality caused by this product. The paper is freely accessible at: http://www.plosntds.org/article/info:doi/10.1371/journal.pntd.0001544

WHA delegates approved the resolution on new Member State mechanism proposing international cooperation on substandard, spurious, falsely-labelled, falsified or counterfeit medical products - 5/29/2012

As reported in the WHO website (http://www.who.int/mediacentre/news/releases/2012/wha65_closes_20120526/en/index.html), the delegates at the 65th World Health Assembly have "approved the resolution on a new Member State mechanism proposing international cooperation on substandard, spurious, falsely-labelled, falsified or counterfeit medical products (http://apps.who.int/gb/ebwha/pdf_files/EB130/B130_R13-en.pdf). Many countries stressed the need for strengthening regulatory authorities and the critically important role that WHO plays in enhancing regional and international networking among the regulators. Emerging channels of distribution such as Internet sales pose a significant threat and require specific solutions. Representatives of NGOs and the pharmaceutical sector expressed their support for the mechanism". Comments are already available in the website of IP Watch (http://www.ip-watch.org/2012/05/26/world-health-assembly-members-gavel-new-mechanism-to-fight-poor-quality-medicines/?utm_source=post&utm_medium=email&utm_campaign=alerts)

A review of poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa - 5/25/2012

The Lancet infectious Diseases recently published a paper on poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa (Gaurvika M L Nayyar et al. Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Inf Dis 2012; 12: 488-496). By reviewing published and unpublished studies, they found worrisome percentages of failure to comply with chemical and packaging analysis, as well as of falsified products. These findings have been retaken by the French newspaper Le Monde (http://www.lemonde.fr/sante/article/2012/05/23/un-tiers-des-medicaments-contre-le-paludisme-seraient-inefficaces_1705260_1651302.html) and by other websites.

A review of packaging of medicines, by Prescrire - 5/3/2012

The journal Prescrire has published a very interesting review on the quality of pharmaceutical packaging, pointing at those shortcomings which may be dangerous for the final user. It can be downloaded, in English, at this website: http://english.prescrire.org/en/

Survey of the quality of anti-tuberculosis medicines circulating in selected newly independent states (WHO 2011) - 4/26/2012

The aim of this survey conducted by the WHO, which is available in: http://apps.who.int/medicinedocs/documents/s19053en/s19053en.pdf was to explore the quality of anti-tuberculosis medicines in use in selected newly independent states of the former Soviet Union, as one of the potential factors contributing to the high burden of multidrug-resistant tuberculosis observed in all of these countries (Armenia, Azerbaijan, Belarus, Kazakhstan, Ukraine, and Uzbekistan). The findings are described in the executive summary, and in a more detailed way in the main text. Noteworthy, "33 samples (11.3%) failed to meet the specifications set for the survey. The zero failure rate among WHO-prequalified samples and those supplied through GDF indicates that these mechanisms are effective in assuring the quality of anti-TB medicines. On the other hand, low content of rifampicin, substantial inconsistencies in ofloxacin dissolution, as well as batch-to-batch and intra-batch inconsistencies are of concern and need to be addressed. These findings may be caused by a combination of inconsistent application of Good Manufacturing Practices and insufficient regulatory supervision".

Contaminated isosorbide mononitrate incident in Lahore Pakistan - 4/26/2012

A serious incident has been reported by WHO: http://www.who.int/medicines/publications/drugalerts/DrugSafetyAlert125.pdf In Lahore (Punjab, Pakistan), 107 patients died and more than 450 suffered from serious adverse reactions, because they received an antianginal medicine (isosorbide mononitrate) which erroneously contained pyrimethamine in quantities large enough to cause substantial overdose. The accident has also been described in the British Medical Journal (Arie S. Contaminated drugs are held responsible for 120 deaths inPakistan.BMJ2012;344:e951 doi: 10.1136/bmj.e951)

The Primacy of Public Health Considerations in Defining Poor Quality Medicines - 4/26/2012

In this article published in Plos Medicine, available at: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001139 Newton and colleagues remind that poor quality medicines, including both substandards and counterfeits, should be fought in a from a public health, patient-centerd approach.

WHO funding shortage risks harming essential medicines work - 1/13/2012

The WHO's financial problems now threaten the department that advises governments on which drugs they must buy

Action to preserve WHO's core functions cannot wait for organisational reform - 1/13/2012

The Lancet, Early Online Publication, 13 January 2012

India Reports Completely Drug-Resistant TB - 1/9/2012

By Maryn McKenna Email Author January 9, 2012 | 2:22 pm | http://www.wired.com