E-DRUG: Tanzania is first African country to reach an important milestone in the
regulation of medicines
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"http://www.afro.who.int/fr/node/10720"
*Brazzaville / 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.
'This is a major African milestone and we are very proud of Tanzania's
achievement, which we hope will inspire other countries in the region,'
says Dr Matshidiso Moeti, WHO Regional Director for Africa. 'Access to
medicines alone, without quality assurance, is not enough. With this
milestone Tanzania makes a big step towards improving the quality of its
health care services.'
Medicines are used to prevent illnesses and treat diseases, helping many
people to lead full and productive lives. However, if produced, stored or
transported improperly, if falsified, or used incorrectly or abused,
medicines can be hazardous and can lead to hospitalization and even
death. For these reasons, it is important to have effective regulatory
systems that also serve to promote timely access to quality medicines.
Fewer than 30% of the world's medicines regulatory authorities are
considered to have the capacity to perform the functions required to ensure
medicines, vaccines and other health products actually work and do not harm
patients. For that reason, WHO and African governments have intensified
efforts to bolster the capacity of regulating medicines in the region.
Over the past years WHO has been supporting African countries, including
Tanzania to strengthen their regulatory entities.
“The core of WHO's work is to empower countries through support and
knowledge transfer so that they can expand access to health services for
their populations,” says Mariângela Simão, WHO Assistant Director General
for Access to Medicines, Vaccines and Pharmaceuticals. 'If countries want
to improve health outcomes, they first need to ensure access to safe and
quality medical products that actually work and benefit patients.'
WHO's assessment of regulatory authorities is based on the 'Global
Benchmarking Tool' - an evaluation tool that checks regulatory functions
against a set of more than 200 indicators- such as product authorization,
market surveillance and the detection of potential adverse-effects – to
establish their level of maturity.
The benchmarking of Tanzanian regulatory authorities was carried out in
phases by a WHO-led team of international experts. Earlier this year, WHO
facilitated self-assessments and conducted a formal evaluation of the
Tanzania Food and Drug Authority (TFDA) on the mainland and the Zanzibar
Food and Drug Agency and required the regulatory authorities to make a
number of adjustments. In the last assessment, Tanzania FDA met all
indicators that define a maturity level 3 agency, the second highest on
WHO’s scale and the target for regulatory systems globally.
Established in July 2003, the Tanzania FDA has come a long way to becoming
a recognized leader in medicines regulation in Africa. The latest
achievement means that medical doctors, pharmacists, chemists and
technicians working for the regulatory authority possess the expertise and
hands-on skills to evaluate medical products, prevent and counteract
associated hazards and are capable of protecting the public from
substandard and falsified medicines.
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*Note for editors*
Access to essential, high-quality, safe and effective medical products is a
cornerstone of a well-functioning health care system. Regulatory
authorities provide the oversight needed to ensure that medicines, vaccines
and medical devices are safe and effective before registering these
products for use. This function is critical in all countries and in Africa
particularly, given that risky medical products easily filter through
porous national borders or are sold outside official channels.
WHO's work to strengthen African regulatory authorities has concentrated on
building capacity through the transfer of knowledge and hands-on training,
and by building cooperative networks that allow authorities in the same
region to save resources by sharing data and workload. The more countries
in the African region comply with WHO standards, the safer will be the
supply of medicines and other medical products for African populations.
Bruneton Carinne <carinne.bruneton@gmail.com>