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WHO Drug Information Vol. 28, No.

4, 2014

WHO Prequalification
Building quality-assured manufacturing capacity in Nigeria

As a fast growing economy and large provider of goods and services to

countries in the region, Nigeria is poised to expand its pharmaceutical
production to achieve self-sufficiency in essential medicines and compete
on regional and global markets. To this end, government health authorities
and local manufacturers requested WHO support and technical assistance
to prequalify several locally produced medicines, as a way to fast-track
the building of local capacity to manufacture medicines according to
international quality standards. An integral part of the process is the
strengthening of national regulatory capacity to enforce these standards
on an ongoing basis.

The Nigerian quest priority diseases meet global standards

While no medicines manufacturer in West of quality, safety and efficacy. By
Africa has so far achieved prequalification evaluating needed pharmaceutical
of a pharmaceutical product by the World products – including those produced in
Health Organization (WHO), Nigeria is countries with limited regulatory capacity
attempting to change the status quo. A – the WHO prequalification team (WHO/
number of companies belonging to the PQT) provides a basis for national and
Pharmaceutical Manufacturers Group international procurers to make cost-
of the Manufacturers Association of effective choices among finished products
Nigeria (PMG-MAN) are working to reach of assured quality.
a manufacturing quality standard that WHO/PQT has increasingly engaged
will enable them to have some of their in activities that go beyond dossier
products WHO-prequalified and apply for assessment and site inspections. The
international medicines tenders. team is training national regulators,
The project has been supported by the providing guidance to manufacturers,
Nigerian government and by the National facilitating registration in countries
Agency for Food and Drug Administration and supporting post-procurement
(NAFDAC). WHO was approached to quality control. The experts who
provide technical assistance to both advise manufacturers in preparing
manufacturers and regulators especially in prequalification submissions work
the areas of good manufacturing practice independently of the prequalification
and dossier submissions in line with WHO dossier assessment and inspection
and international standards. groups. The main objective of these
activities is to disseminate sound
Role of WHO knowledge and practices and to ensure
The WHO prequalification programme that all the actors work together according
aims to ensure that medicines for

WHO Prequalification WHO Drug Information Vol. 28, No. 4, 2014

to the same international quality 70% of its medicines, mainly from Asia,
standards. Europe and the Americas.
From the WHO perspective, the In terms of the regulatory environment,
Nigerian project is in line with these aims. the National Agency for Food and Drug
Given the importance of Nigeria in its Administration and Control (NAFDAC)
geo-economic region, it is hoped that has in recent years enacted numerous
increased production of quality medicines enforcement activities to combat
in the country will also lead to better substandard and counterfeit medicines. It
quality medicines in West Africa as a has also consistently worked with WHO to
whole. strengthen its quality control and post-
marketing monitoring of pharmaceuticals.
Snapshot of Nigeria’s But challenges persist, which are largely
pharmaceutical landscape related to insufficient capacity to ensure
Nigeria is a natural candidate for the full regulatory functions in line with
local capacity strengthening offered by international standards, including speedy
WHO/PQT. The country’s pharmaceutical registration of medicines.
industry is vibrant and expanding, with Despite these challenges, the country’s
over 100 pharmaceutical manufacturers pharmaceutical sector is one of the
and a mostly local ownership strongest in Africa in terms of size, range
organized under the umbrella of the of products manufactured and potential
Pharmaceutical Manufacturers Group to meet and sustain international
of the Manufacturers Association of pharmaceutical quality standards.
Nigeria (PMG-MAN). Nigeria accounts for
approximately 60% of the pharmaceutical The project
production in the Economic Community Selection of manufacturers
of West African States (ECOWAS) by In 2011 NAFDAC and WHO/PQT came
volume (1). Production is geared mostly to an agreement on the principles of the
towards essential medicines, including project and, in collaboration with PMG-
antimalarials and HIV medicines. MAN, selected eight manufacturers that
On the other hand, drug manufacturers had expressed commitment to invest
in Nigeria face a number of constraints. in quality improvements and that were
These include a weak financial base, deemed technically ready to embark on a
high production costs as a result of the programme to align their manufacturing
high cost of imported pharmaceutical operations with international quality
ingredients and machinery, infrastructural standards. WHO/PQT arranged for
problems, outdated technology and weak external experts to verify the production
distribution systems. In addition, as there standards at the manufacturing sites
are no contract research organizations and to assess product data and
in West Africa proven to work in line with documentation.
international standards, manufacturers
need to rely on expertise from Europe and Capacity-building
Asia when they require bioequivalence Based on the results of the assessments
studies or specific laboratory testing. Due by the external experts, WHO/PQT
to these factors, the country imports about initiated an intensive capacity-building
programme for Nigerian manufacturers

WHO Drug Information Vol. 28, No. 4, 2014 WHO Prequalification

and regulators. Since 2012, several departments, such as the Clinical Trial/
training sessions on good manufacturing Pharmacovigilance and Post Marketing
practices, combined with site visits at Surveillance and Drug Evaluation
participating companies, have been and Research Directorates. NAFDAC
co-organized by WHO/PQT and NAFDAC. professionals also participate actively in
In parallel, WHO-appointed experts have trainings organized for local industry.
advised the companies on specific quality The close support by the WHO Country
issues related to various medicines. Office has also been an asset to the
In response to observations raised project. The process has opened doors for
during the audits and document reviews, Nigerian stakeholders and international
the companies implemented a series of organizations to work together more
corrective actions. They upgraded their closely.
equipment, improved manufacturing
processes, and established professional Pre-submission audits
procedures to build documentation for The WHO prequalification team normally
pharmaceutical ingredients and finished plans its inspections on a risk-basis
products.These corrective actions once companies have submitted a
exceed currently applicable regulatory prequalification dossiers. To enable
requirements in Nigeria. Implementation is applicants to work on product dossiers
monitored by NAFDAC professionals, who and good manufacturing practice (GMP)
report on progress to WHO. The process in parallel, the new concept of pre-
is ongoing, with a current focus on the submission GMP audits was piloted in
development of technically sound product Nigeria. An inspection can be scheduled
dossiers. before a dossier has been submitted,
WHO/PQT also works with the provided that the expert advisors
participating manufacturers to identify and NAFDAC notify WHO/PQT that
all their medicinal products eligible the manufacturer has achieved – in
for prequalification. This will facilitate principle – compliance with WHO GMP.
progress towards GMP-compliant Prequalification inspectors then verify the
production of additional medicines of status of general GMP compliance while
interest for international organizations. completion of a prequalification dossier is
For example, interest may come from UN still ongoing.
Commission for Lifesaving Commodities Successful audits represent a milestone
for Women and Children (UNCoLSC), in the progress towards prequalification,
given that a large portion of the medicines and the outcomes are considered by
needed in the West African region are organizations looking for companies that
reproductive health and paediatric manufacture needed health products in
products. line with international GMP.
A series of pre-audits was organized in
Regulatory and in-country support 2013 and 2014 at Nigerian manufacturing
On the regulatory side, NAFDAC has sites in close co-operation with NAFDAC,
proved to be a strong partner in capacity- whose regulatory inspectors played an
building efforts. The authority has active role in verifying the corrective
upgraded its laboratories, recruited more actions adopted after the audit and
specialized staff and has established new drafting parts of the inspection reports.

WHO Prequalification WHO Drug Information Vol. 28, No. 4, 2014

Funding Prequalification dossiers

The Nigerian Ministry of Health has One Nigerian company has submitted a
invested considerably into the project. prequalification dossier to WHO and this
In addition, advocacy is on-going for has been accepted for screening. Another
a special intervention fund from the submission is expected before the end of
development banks in Nigeria, ECOWAS the year, with more to follow in the near
and the African Development Bank future. The choice of medicines includes
(AfDB). antimalarials, antiretrovirals, zinc sulphate
WHO’s participation in the project has and antibiotics.
largely depended on financial backing
from UNITAID, which was used to Outlook and impact
support technical assistance, transfer of Tenders
knowledge, capacity building, audits and The achievements made by participating
inspections and human resources. manufacturers open up opportunities for
From the manufacturers’ side, international tenders, where compliance
information from PMG-MAN indicates that with stringent GMP is a minimum
the companies participating in the project requirement for any pharmaceutical
have invested a cumulative amount product. Additional requirements apply
exceeding USD 400 million over the last to key categories such as antiretrovirals,
four years. anti-TB products and antimalarials.
In these categories, compliance with
Achievements stringent GMP enables manufacturers to
GMP compliance apply for review of relevant products by
The pre-submission audits led to a the Expert Review Panel (ERP). Products
landmark success being achieved in April that have received a positive ERP opinion
2014, when Swiss Pharma Nigeria Limited can then compete in international tenders
(Swipha) was confirmed to be operating in situations where no or only one WHO-
at an acceptable level of compliance with prequalified or stringently authorized
WHO GMP guidelines for the manufacture competitor product is available on the
of oral solid dosage forms (2). Swipha market (4).
was the first pharmaceutical manufacturer It is hoped that African ministries
in Sub-Saharan West Africa to pass of health, regional initiatives and
a GMP inspection by WHO/PQT after international procurers will consider WHO
implementing successful corrective and GMP-compliant African manufacturers
preventative action (CAPA). Three other in tenders for purchase of medicines in
companies participating in the project - the region. This would support quality-
Evans Medical Plc, May & Baker Nigeria assured local production, and would
Plc and CHI Pharmaceuticals Ltd – signal recognition of the cost that quality
reached this standard in November 2014, assurance entails for manufacturers.
after successfully implementing corrective
and preventive action (CAPA) identified Raising the bar for medicines quality
during WHO pre-submission audits in May Feedback from PMG-MAN suggests
2014 (3). that the project is beginning to yield
wider benefits. The understanding of
world class manufacturing practices in

WHO Drug Information Vol. 28, No. 4, 2014 WHO Prequalification

Nigeria has improved. As a result, the submitted by Nigerian companies in line

perception of the importance of quality in with international standards.
pharmaceutical manufacturing is gradually
shifting. Other Nigerian companies do Challenges
not want to be left behind and are also Further challenges lie ahead before
becoming interested in upgrading their the Nigerian pharmaceutical sector
production, with support from PMG-MAN, will be able to reach the level of quality
to achieve WHO prequalification of their production and autonomy to which it
products. aspires. Most challenges are related
NAFDAC has benefitted through to the need for further guidance in
hands-on participation in prequalification manufacturing practices, dossier
inspections, assessments, training development, bio-equivalence and supply
workshops and other capacity-building chain management. To address these
activities, with access to prequalification needs, the initial timeline for the project
inspection and assessment reports. was extended.
Important also is the choice of products
Local regulatory oversight for prequalification, which must be well
Medicines regulation is essentially a considered to ensure that it serves both
public function that should be assured quality and commercial objectives.
by the governments of countries where Other challenges are related to
medicines are produced and used. financing. Given the fact that WHO
NAFDAC’s active follow-up of individual prequalification will not occur immediately,
manufacturers’ progress and verification financial incentives may well be needed
of corrective actions has proved extremely for the companies to continue to progress.
valuable in working towards this goal. The And while WHO prequalification of a
process has strengthened communication number of Nigerian-made products in
between industry and regulators, with the near future seems feasible and can
a common understanding of the quality enable companies to win international
issues at stake. procurement tenders, further change is
The cooperation with NAFDAC under needed to ensure a sustainable supply
this project marks the start of a new model of quality medicines in the region and to
whereby the local regulatory authority resolve supply management problems.
assumes responsibility for ensuring
that WHO prequalification requirements Conclusion
continue to be met. This approach is of The close cooperation between Nigerian
course dependent on objective evidence manufacturers, regulators and WHO
that the local regulatory authority can starts to produce results. The general
in fact conduct routine monitoring and understanding of international regulatory
maintenance to the required standards. standards has improved, and several
The activities will therefore be coordinated companies are well on their way towards
with, and reported to, WHO/PQT. In prequalification of their products.
addition, NAFDAC assessors will work As corrective measures and upgrades
closely with the WHO prequalification continue, Nigerian authorities and
assessors to review product dossiers manufacturers will need to find ways to
raise sufficient funds to put into place

WHO Prequalification WHO Drug Information Vol. 28, No. 4, 2014

sustainable structures and processes References

for production of quality-assured 1 Nigeria pharmaceutical country profile.
pharmaceuticals. Published by Federal Ministry of Health
Spokespersons of NAFDAC and in collaboration with the World Health
Organization. June 2011.
PMG-MAN have expressed satisfaction
with progress made to date and 2 WHO/PQT. First Nigerian manufacturer
considered compliant with WHO GMP.
remain firmly committed to enhancing
Prequalification Update, 4 April 2014.
the pharmaceutical sector to make
3 WHO/PQT. Three more Nigerian companies
it work both for public health and the meet international pharmaceutical
pharmaceutical industry. manufacturing standards.
WHO will continue to advocate for Information note, 21 November 2014.
greater support of this kind of cross- 4 WHO/PQT. Expert Review Panel. A rapid
sectoral capacity-building. Ensuring that quality risk assessment mechanism for
affordable, quality-assured medicines are assessing needed pharmaceutical products
within reach of all those who need them is that have not completed a stringent
assessment. Briefing paper: 27 April 2012.
a pillar of an effective health system and
an area requiring greater attention from
the international community.