E-DRUG: Prequalification of medicines saves lives
[The WHO prequalification programme has made considerable progress in recent
years. See below a new WHO feature story on it which gives a good overview.
More in-depth data at the WHO Prequalification website
http://apps.who.int/prequal/ which very transparently lists all processes,
results and even the actual inspection reports. WB]
Every year, millions of patients in resource-limited countries receive
life-saving medicines that are purchased by or through international
procurement agencies such as UNICEF, UNFPA, UNITAID and the Global Fund to
Fight AIDS, TB and Malaria. The WHO Prequalification of Medicines Programme
ensures that selected medicines supplied by these agencies meet
international standards of quality, safety and efficacy.
The Programme has prequalified more than 280 products since it was
established in 2001. Its original focus was medicines for treating HIV/AIDS,
TB and malaria; but this expanded in 2006 to cover medicines for
reproductive health, in 2007 to cover medicines for influenza and then again
in 2008 to cover zinc for the management of acute diarrhoea in children.
More recently, the Programme started to evaluate the quality of medicines
for treating neglected tropical diseases
"Ensuring that patients have access to quality-assured medicines to treat
AIDS, tuberculosis and malaria has been a priority for the Global Fund since
its inception in 2002," said Debrework Zewdie, Deputy Executive Director of
the Global Fund to Fight AIDS, Tuberculosis and Malaria. "The WHO
Prequalification Programme played a critically important role in supporting
the Global Fund Board in its efforts to establish and strengthen its Quality
Assurance Policy for Pharmaceutical Products. Today, WHO prequalification
status gives Global Fund grant implementers the confidence they need that
they are procuring medicines that meet internationally recognized
How prequalification works
Manufacturers apply to WHO to have a product evaluated. They must provide
comprehensive information about the product's quality, safety, and efficacy.
This is evaluated by a team of assessors - including staff from WHO and
experts from national regulatory authorities worldwide.
In addition, a WHO inspection team visits the manufacturing site(s) of both
the finished pharmaceutical product and its active pharmaceutical
ingredient(s) to verify that these comply with WHO good manufacturing
practice (GMP). The team, which includes an inspector from a "stringent
regulatory authority" may also verify that any contract research
organization that conducted any studies relating to the product complied
with good clinical and laboratory practices. When the comprehensive
scientific assessment and necessary inspections indicate that the product
meets international standards for quality, safety and efficacy the product
is added to the WHO list of prequalified medicinal products. But if the
manufacturer fails to provide sufficient data, or if its manufacturing site
is found to not comply with GMP, it is requested to provide additional data,
to carry out additional studies, and/or to carry out corrective action at
its manufacturing site(s).
Ongoing monitoring and intervention to assure quality
To ensure prequalified products continue to meet the WHO specifications, the
Programme regularly tests samples of prequalified medicines and re-inspects
manufacturing sites. It also assesses changes made by manufacturers to their
prequalified products quality specifications and/or to the manufacturing
processes of those products to ensure that these variations do not affect
quality and safety.
Moreover, after 5 years, a prequalified product must undergo
If quality issues are identified in relation to a prequalified product, WHO
intervenes swiftly, applying a complaint procedure that stipulates thorough
investigation, including on-site investigation and quality control analysis.
In one example last year in Kenya, WHO's prequalification programme was
notified by an NGO of a quality complaint. As a consequence of a swift
inspection of the suspected manufacturer the programme found evidence of
unauthorized relabeling of prequalified lamivudine, zidovudine and
nevirapine tablets (antiretrovirals) with the fraudulent aim to extend its
expiry date. The Kenyan regulatory authority was able to confirm these
findings and ordered a recall of tablets by batch number.
"However, neither assessment nor monitoring alone can guarantee the safety
of a country's medicines supply", says Dr Cornelius de Joncheere, Director
of WHO's Department of Essential Medicines and Health Products. "There are
multiple threats to medicines supply systems, especially in regions where
regulatory and enforcement systems are the weakest. That is why this
Programme also works with countries to develop their capacity to regulate
medicines entering their markets."
In 2011, the Programme organized or co-organized training in medicines
quality and safety issues for more than 1600 participants, including
regulators, manufacturers, laboratory staff and partner organizations. The
hands-on training includes a rotational fellowship, and invitations to
developing country assessors and inspectors to participate in Programme
activities under the supervision of experienced senior experts.
Added benefits of prequalified medicines
One consequence of the prequalification programme is that it has helped
bring down drugs prices in low- and middle-income countries.
"The resultant price decreases mean that many more patients can be treated,"
says His Excellency Maurice Peter Kagimu Kiwanuka, Uganda's Ambassador to
Switzerland. "Ten years ago, one month of first line antiretroviral drugs
treatment for HIV cost US$ 1000. Today it costs less than US$ 50. So in
2003, only 17 000 patients received antiretroviral in Uganda, whereas by
September 2010, this number had increased to just under a quarter of a
Experts in the field credit prequalification as one of the critical success
factors in getting vital medicines to large numbers of people with no
compromise of quality.
"The creation of prequalification was a radical and courageous move on WHO's
part and it showed the international community that ambitious treatment
targets could be achieved," said Ellen't Hoen, international pharmaceutical
policy expert from the University of Amsterdam, The Netherlands.
Perhaps most importantly, the Programme has helped create a level playing
field by ensuring that medicines are evaluated according to
internationally-agreed, transparent standards, no matter where or by whom
they are produced.
More than medicines
In addition to prequalification of medicines, WHO also provides a similar
service for quality control laboratories, vaccines, and diagnostics.
"WHO prequalification programmes are enabling countries like Uganda to
access quality assured medicines and vaccines." Kiwanuka said. "Through them
we have been able to expand our treatment and vaccination programmes, and to
make significant progress towards meeting health targets."
More details at: http://apps.who.int/prequal/