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Research Article
Impact of regulatory requirements
on medicine registration in African
countries – perceptions and
experiences of pharmaceutical
companies in South Africa
Abstract
Objective: Access to medicines has long been and remains a challenge in African countries. The impact of medicines registration
policies in these countries poses a challenge for pharmaceutical companies wanting to register medicines in these countries. The recent
AMRHI (African Medicines Registration Harmonisation Initiative) has increased the focus on the need for harmonisation. Medicines
registration regulations differ across African countries. Anecdotal evidence, based on the experience of pharmaceutical companies
on progress towards harmonisation is somewhat different, i.e. that country specific requirements were a barrier to the registration
of medicines. The objective of this study was therefore to determine the nature and extent of regulatory hurdles experienced by
pharmaceutical companies who wish to register and supply medicines to African countries.
Methods: This cross-sectional descriptive pilot study was conducted across pharmaceutical companies, both local and multinational.
These companies were based in South Africa and were also members of Pharmaceutical Industry Association of South Africa (PIASA).
The pharmaceutical companies supply both the private and public sectors. An online survey was developed using Survey Monkey.
Survey questions focused on the following strands: nature and level of current supply of medicines to African countries by companies,
general regulatory requirements, region specific questions and country specific questions across four regional economic communities
in Africa, namely; Southern African Development Community (SADC), East African Community (EAC), Economic Community of the
West African States (ECOWAS) and Economic Community of Central African States (ECCAS).
Results: A total of 33 responses were received to the questionnaire of which 26 respondents were from the PIASA Regulatory
working group and 7 were from the PIASA Export working group.It was noted that since most of the regulatory authorities in Africa
are resource-constrained, harmonisation of medicine registration policies will contribute positively to ensuring the safety, quality and
efficacy of medicines. The experience of pharmaceutical companies indicated that country specific regulatory requirements are a barrier
to registering and supplying medicines to African countries. In particular, GMP inspections, GMP inspection fees and country specific
labeling were cited as key problems.
Conclusion: Pharmaceutical companies operating in African markets are experiencing difficulties in complying with the technical
requirements of individual African countries. Further research is required to provide a balanced perspective on the country specific
regulatory requirements vs. the African Regulatory Harmonisation Initiative (AMRHI).
Keywords: medicine registration, labeling, pharmaceutical policy, Good Manufacturing Practice
31
Southern Med Review Vol 5 Issue 1 July 2012
Review
Southern Med
Kirti Narsai
1,2
, Abeda Williams
3
, Aukje Kaija Mantel-Teeuwisse
2
1
Pharmaceutical Industry Association of South Africa (PIASA), Johannesburg, South Africa
2
Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands
3
Janssen Pharmaceutica, Johannesburg, South Africa
Address for Correspondence: Kirti Narsai, Pharmaceutical Industry Association of South Africa (PIASA), P.O. Box 12123, Vorna Valley, 1686,
South Africa. Email: kirti@piasa.co.za
Received: 21st Feb 2012
Accepted: 6th June 2012
Published Online: 23rd July 2012
Citation: Narsai K, Williams A, Mantel-Teeuwisse AK. Impact of regulatory requirements on medicine registration in African countries-
perceptions and experiences of Pharma companies in South Africa. Southern Med Review (2012) 5;1:31-37
Impact of regulatory requirements on medicine registration
32
Southern Med Review Vol 5 Issue 1 July 2012
Medicines are essential to healthcare and should be available
to the inhabitants of every country. Medicines regulation
aims to ensure that medicines circulating in national and
international markets are safe, effective and of good quality, are
accompanied by complete and correct product information, and
are manufactured, stored, distributed and used in accordance
with good practices [1].
For many years, African medicines regulatory authorities
(MRAs) have managed a broad range of responsibilities, often
with limited resources [2]. Their focus has generally been on
providing their population with access to a wide range of
affordable essential medicines, usually multi-source generics,
with less emphasis on rapid access to the latest products. As a
result, African national MRAs may have experience in managing
generics, but many have only limited experience in assessing,
approving and registering innovator products, the vast majority
of which are for global chronic diseases, such as diabetes,
hypertension and cancer [2].
It is well documented that the African MRAs are under
resourced and lack skills and capacity to perform their functions
adequately [1, 3, 4]. Coupled with this is changing technology
as well as advancements made in medicines, e.g. the increased
development of biological medicines and the increased focus
on healthcare in Africa. It is clear that intervention is required
to ensure that the gap between African MRAs and developed
country MRAs and the healthcare needs of their populations do
not widen.
The African Medicines Registration Harmonisation (AMRH)
Initiative is a welcome move. Investing in the AMRH initiative
also provides an opportunity for African countries to strengthen
their regulatory capacity, use their financial and human
resources more effectively, thereby creating a more conducive
environment for the attainment of the health-related Millennium
Development Goals (MDGs) [5].
Very little data is available regarding pharmaceutical companies
experiences in registering and supplying medicines in Africa.
This study aims to shed light on the pharmaceutical companies’
experiences with regards to compliance with technical
requirements of medicines registration. This in turn can have an
impact on the availability of medicines in African markets.
Objectives
The objective of this survey was to determine both the nature and
extent of regulatory hurdles as experienced by pharmaceutical
companies in seeking registration or market authorisation for
medicines in African countries.
Methods
Data collection
For this cross-sectional descriptive pilot study a short survey
was developed. The target groups for the survey were the
Pharmaceutical Industry Association (PIASA) Export and PIASA
Regulatory working groups. The Pharmaceutical Industry
Association is the largest trade association in South Africa
representing multinational and local companies. The group
consists of individuals that have responsibility for either
commercial or regulatory issues related to medicine registration
in the African countries that the companies supply medicines
to. Members of the Regulatory and Export working group of
PIASA member companies were invited to complete the survey
via email containing a hyperlink to the online survey during April
2010. Reminders were sent during April to July 2010 and the
survey was closed at the end of July 2010. Separate surveys
were sent to the Export and Regulatory groups of PIASA.
Only one response per company, per function, i.e. export and
regulatory, was accepted to avoid duplication of responses. In
instances where more than person responded from a particular
company, duplicate responses were allowed only where it
was appropriate to provide a more comprehensive view to a
particular question. An online survey was developed using Survey
Monkey. Through the experience of previous PIASA submissions
to regulatory authorities and through anecdotal feedback from
PIASA Export and Regulatory working groups, questions were
developed to address key issues. Survey questions focused
on the nature and level of current supply of medicines to
African countries, availability of generics and decision-making
around medicine supply and views and experiences in dealing
with regulatory requirements. The questions regarding GMP
requirements and country-specific requirements were posed
across four regional economic communities in Africa which
include: Southern African Development Community (SADC),
East African Community (EAC), Economic Community of the
West African States (ECOWAS) and the Economic Community
of Central African States (ECCAS). The survey also included
open-ended questions to allow respondents to express their
views freely and in an unstructured manner.
Data Analysis
Proportions were used in descriptive analyses of dichotomous
and categorical variables. Country and regional categorisation
was based on the country listing per Regional Economic
Communities (RECs), as per the African Medicines Registration
Harmonisation Initiative (AMRHI). The four RECs were East
African Community (EAC), Economic Community of Central
African States (ECCAS), Economic Community of West African
States (ECOWAS) and the Southern African Development
Community (SADC). Some countries belong to more than
one REC – refer to Table 1 for country listing for each REC,
highlighting overlapping countries [5].
Introduction
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Southern Med Review Vol 5 Issue 1 July 2012
Table 1: Country listing of four Regional Economic Communities
in Africa
Results
A total of 33 responses were received to the questionnaire of
which 26 respondents were from the PIASA Regulatory working
group and 7 were from the PIASA Export working group. After
exclusion of duplicate responses it was found that the 14
companies were from the regulatory group and five companies
were from the export group (four of these companies were
also represented in the regulatory group). Not all respondents
answered all the questions and therefore the number of
responses per question varies.
Current vs. future supply of medicines in Africa
Results show a high level of participation of companies in the
various countries in Africa. All companies supplied medicines
to the SADC region; however, the combinations and country
representations differ across companies. Medicine supply by
these companies covered a broad spectrum of therapeutic
areas including diseases where the prevalence in Africa is high
(viz. anti-infectives, HIV/AIDS) and non-communicable diseases
(NCDs) viz. oncology, endocrinology and cardiovascular disease.
The top therapeutic areas for all medicines supplied were as as
follows: cardiovascular, endocrinology, oncology, allergy and
anesthesia. The top therapeutic areas for genericmedicines
were cardiovascular, allergy, anti-infectives and endocrinology.
Although the current supply of medicines by companies is
significant, six companies indicated that they have made a
decision not to supply medicines into some African markets.
Specific countries mentioned included Ghana, Nigeria, Ethiopia,
Tanzania, Kenya, Uganda, Mozambique and Zimbabwe.
Reasons for companies (cited by the export group) in making
decisions not to supply medicines to specific African countries
were: registration costs; commercial; retention costs, GMP
inspection fees and GMP inspection requirements. When asked
in which markets these decisions have been made, the responses
included Ghana, Uganda and Sudan. Overall, reasons related
to the medicine registration process outweighed commercial or
market reasons for these decisions.
All companies (five export group respondents) indicated that
they had experienced instances where they were unable to
supply medicines to African markets. The reasons cited for the
interrupted supply were related to regulatory requirements,
particularly medicines registration. One respondent cited
concerns of product diversion to Western countries as the
reason. The same five companies indicated that they had made
decisions not to supply specific medicines to African countries.
Only one company indicated that their products had been held
back at customs – no additional information was provided. All
five companies in the export group stated that their businesses
were negatively impacted by the availability of unregistered
medicines in African countries. The commercial impact of this
was rated between medium and severe (medium =4; severe=1).
One company mentioned Zimbabwe, Zambia, Mozambique and
Malawi as the countries where the availability of unregistered
medicines was a problem.
SADC ECCAS ECOWAS EAC
Angola Angola Benin Burundi
Botswana Burundi Burkina Faso Kenya
Democratic
Republic
of Congo
Cameroon Cape Verde Rwanda
Lesotho
Central
African
Republic
Cote d’Ivoire Tanzania
Madagascar Chad Gambia Uganda
Malawi Congo Ghana
Mauritius
Democratic
Republic
of Congo
Guinea
Mozambique
Equatorial
Guinea
Guinea
Bissau
Namibia Gabon Liberia
Seychelles Rwanda Mali
South Africa
Sao Tome
& Principe
Niger
Swaziland Nigeria
Tanzania Senegal
Zambia Sierra Leone
Zimbabwe Togo
Table 2: Reasons for non-supply of medicines (n=5)
Reason
No. of Companies citing reason for
not supplying medicines to specific
African countries
Registration costs 4
Commercial 3
Retention costs 3
GMP Inspection fees 3
Lengthy registration 2
GMP inspection requirements 2
Unregistered medicine
already available
1
Risk of counterfeit medicine 1
Generic medicine
already available
1
Impact of regulatory requirements on medicine registration
Registration of medicines
Registration timelines experienced by companies varied in
general between one and three years although time could vary
between countries and three companies indicated more than
three years (Fig 1). Although the results were mixed in terms of
whether current African medicines registration requirements are
in line with international standards, some respondents indicated
that there is a level of alignment with international standards.
Nine companies indicated that the registration requirements in
African countries were in line with international standards (Table
3).
The majority of respondents indicated that there was a lack
of recognition of international standards by African regulatory
authorities with no differences across RECs. Of the total of 14
companies, 13 stated that country specific requirements, in
general, were problematic to implement. The three main areas
that respondents found problematic were country-specific
labeling requirements, GMP inspection requirements and GMP
inspection fees. Another company indicated that the regulators
lacked the expertise to register biologic agents.
Figure 1: Reported timelines for medicine registration (n=14, 1
company did not provide a timeline)
GMP inspections have been cited by most companies operating
in Africa as a barrier to the registration and supply of medicines.
Seven companies noted that GMP inspection fees were too
high, while seven companies indicated that GMP inspection
requirements were a barrier to medicine registration (Table
3).Additional comments provided by the respondents included
that the cost of maintaining the product was higher than the
returns and sales volumes do not justify high costs nor cover
registration renewal fees. A correlation was identified between
commercial decisions not to supply medicines and GMP issues in
specific countries (Table 4).
Table 3: Summary of survey results across the different Regional
Economic Communities
34
Southern Med Review Vol 5 Issue 1 July 2012
3
5
2
3
0 1 2 3 4 5 6
1
year
2
years
3
years
> 3
years
No of Companies
Question
EAC
N=11
ECCAS
N=8
ECOWAS
N=8
SADC
N=14
No. of Products
supplied to African
countries (no.
of responding
companies)
10 7 10 14
≤10 products 3 4 3 6
11-20 products 3 3 1 4
>20 products 4 2 3 5
Alignment of
registration
requirements
with international
standards (no. of
respondents)*
11 8 8 15
True 1 1 1 2
True in some cases 6 5 4 9
False in some cases 1 1 1 1
False 2 0 1 2
No information known 1 1 1 1
Lack of recognition
of international
standards (no. of
respondents)
10 7 7 15
Yes 9 6 6 13
No 1 1 1 2
Are GMP inspection
requirements a barrier
to registration of
medicines? (no. of
respondents)*
9 7 7 14
Yes 7 6 5 8
No 0 0 0 1
No opinion 2 1 2 5
Views on GMP
inspection fees (no.
of respondents)*
10 7 7 15
Too high 7 5 4 7
Appropriate 1 1 1 2
Too low 0 0 0 0
Unknown 2 1 2 6
Are country specific
labeling requirements
problematic to
implement for supply
of medicine to African
markets? (no. of
respondents)*
10 6 7 14
Yes 10 6 7 13
No 0 0 0 1
Not applicable 0 0 0 0
*This is a subset of companies that indicated that they supply medicines
in these regions (Regulatory group); data is based on no. of respondents
rather than no. of companies
**This is a subset of companies that indicated that they supply medicines in
these regions (Export group and Regulatory groups); data is based on no. of
respondents rather than no. of companies
Impact of regulatory requirements on medicine registration
Table 4: Countries where companies experience problems with
GMP inspections
Withdrawal/discontinuation of medicines
(export and regulatory)
Of concern is that nine companies indicated that they have
stopped supplying between one and five products. When
probed for reasons for the withdrawal of the products from
market, the reasons cited include registration, renewal and
GMP inspection fees. One company indicated that their product
had been replaced by a more innovative/convenient dosage
form while another stated that opportunistic distributors and
parallel importers bringing in counterfeit and cheap generics
had led them to withdraw their products. The therapeutic areas,
in which the products were withdrawn, included allergy, anti-
infective, gastroenterology, HIV/AIDS, cardiovascular, metabolic
disorders, pain management, psychiatry and gynecology.
Eleven companies indicated that counterfeit medicines were
a problem in some markets in Africa; specifically Kenya and
Uganda. Respondents were also asked to supply reasons for
the interrupted supply to determine a link, if any, to regulatory
requirements. Reasons cited included delays in approval of post
registration amendments to registration dossiers.
African Medicines Registration Harmonisation
Initiative (AMRH)
Overall, 82% of respondents were positive about the AMRHI.
While providing additional feedback some respondents stated
that previous attempts at achieving harmonization had failed
due to a lack of political will and commitment to implement.
Survey respondents were asked about their views on the public
health impact of the current requirements for registration
of medicines in African markets. There were strong views
expressed regarding the delayed access to medicines and the
resultant impact on health outcomes for patients. Another
view was that having stringent regulatory requirements would
contribute to keeping counterfeit medicines out of the market.
Ethiopia was cited as an example of good management in this
regard by requiring that medicines need to be on the essential
drug list (EDL) before they can be registered.
Discussion
The pharmaceutical companies that participated in the survey
have a strong presence in African markets. Overall, the majority
of companies indicated that technical issues related to the
registration and supply of medicines to these countries were
problematic to implement and also a barrier to supply. Although
there is some literature on the resource constraints of regulatory
authorities in Africa [1, 3, 4, 5], we were unable to find data on
pharmaceutical company experience in registering and supplying
medicines to Africa. The question explored in this study was
whether technical requirements for medicine registration was
considered a barrier to registration and supply of medicines. The
results showed that country specific requirements, in particular,
are problematic to implement. The survey results indicated a link
between pharmaceutical companies experiencing interrupted
supply and regulatory requirements. The lack of alignment with
international standards, impact of counterfeit medicines, GMP
inspections, have impacted and will continue to impact product
supply, unless changes are made to country-specific requirements
as well as the recognition of international standards.
International standards contribute greatly to companies’
ability to comply with regulatory requirements and from the
regulator’s point of view [6], it ensures not only that high
standards are maintained but it also assists with functioning
optimally in a resource constrained environment [7, 8, 9]. An
efficient, predictable registration timeline will promote access
to new medicines by encouraging more companies to register
medicines in Africa. It is expected that this will positively impact
the availability of medicines.
Country specific labeling requirements increase the cost of
medicines to specific African countries and in some cases
pharmaceutical companies either cease to supply medicines
or have made decisions not to supply new medicines to these
countries.
The costs, for GMP inspections, were cited as prohibitive by
respondents when considering registration and supply of
medicines to specific African markets. The potential impact of
increased number and frequency of GMP inspections include
potential delays in approval and medicine supply. Furthermore,
the cost of GMP inspections could be a deciding factor in
whether companies pursue registration in a country or not.
35
Southern Med Review Vol 5 Issue 1 July 2012
Region GMP issues
Commercial decision not to
supply
SADC
Tanzania Tanzania
South Africa
Botswana
Mozambique Mozambique
Zimbabwe Zimbabwe
ECOWAS
Ghana Ghana
Nigeria Nigeria
Togo
EAC
Kenya Kenya
Uganda
ECCAS
None None
Impact of regulatory requirements on medicine registration
36
Southern Med Review Vol 5 Issue 1 July 2012
Opportunity costs in this context can be defined as the number
of products that will not be registered or supplied to specific
African markets therefore resulting in revenue losses for the
NMRA as well as the pharmaceutical companies concerned.
Perhaps more importantly, there are costs to the healthcare
system as a result of the unavailability of certain medicines [10,
11].
Current regulatory requirements should be carefully scrutinized
to determine whether they are value-added or non-value added
with respect to the medicine registration process. In this way,
the current registration processes can be streamlined, thereby
shortening the overall registration timeline for medicines. There
is a pressing need to address some of the regulatory burdens
experienced by pharmaceutical companies in the short term,
which will not only alleviate the current issues cited, but will
also contribute positively to the achievement of the objectives
of the AMRHI.
Medicine registration harmonisation will positively impact
all stakeholder groups as illustrated in Figure 2 [5, 8, 10].
Regulatory authorities will benefit in terms of improved
expertise, collaboration with other regulatory authorities and
operational efficiency through sharing of information and
recognition of established regulatory authority decisions.
Healthcare professionals will benefit through the availability
of more treatment options in order to optimise patient
management. Pharmaceutical companies will benefit through
the establishment of new markets and the improved ability
to comply with regulatory requirements related to medicine
registration. Patients will benefit through improved supply of
medicines, access to high quality medicines that comply with
stringent requirements of safety, quality and efficacy and
reduced risk of use of counterfeit medicines.
Limitations of this study include the small sample size and
that there may be bias in responses which is inherent in self
reported data. The small sample size did include diverse
companies, including multinational, R&D based and local
generic companies. It is acknowledged that opinions may differ
even between representatives from the same company. The
literature states that NMRAs in Africa have to face a multitude
of issues affecting medicine regulation under sometimes
severely resource constrained circumstances [3, 4, 5]. Risks of
over-regulation and under-enforcement are very real and can
be avoided through co-operation amongst regulatory agencies
that are better resourced and skilled in maintaining the highest
levels of technical standards. Further research is required to
understand the regulator perspectives on country specific
requirements which at face value seem to be at odds with the
objectives of the African Medicines Regulatory Harmonisation
Project.
Figure 2: Benefits of Harmonisation [adapted from reference
5, 8 & 10]
Conclusion
It is clear from the results of this survey that pharmaceutical
companies operating in Africa are experiencing difficulties in
complying with the technical requirements of individual African
markets. The level of complexity is increased by the consolidated
manufacturing and internal supply chain arrangements
within pharmaceutical companies. Managing internal and
regulatory compliance requirements is resulting in companies
making decisions not to supply medicines to specific African
markets. There also seems to be a disconnect between the
objectives of the AMRHI and the experiences of pharmaceutical
companies at a country level. It is recommended that further
research is undertaken in-order to investigate country specific
requirements both in terms of intention and impact and also
from pharmaceutical company and regulator perspectives.
Authors’ Contributions
Kirti Narsai had the original idea for the paper and wrote the
first draft, which was based on information requirements
expressed by Eric Buch. Kirti Narsai designed the questionnaire
in collaboration with Abeda Williams. Kirti Narsai also carried
out the data analysis . Aukje Mantel-Teeuwisse contributed to
drafting the article and reviewing the data analysis. All authors
contributed to the revision of the paper and approved the final
version.
Acknowledgements
The Pharmaceutical Industry Association of SA (PIASA) is a trade
association of companies involved in the manufacture and/
or marketing of medicines in South Africa. The membership
of 18 companies includes a broad representation of foreign
multinational pharmaceutical companies and local and generic
companies, both large and small. We would like to thank the
member companies, in particular the members of the PIASA
regulatory and export working groups who participated in
the survey. We would also like to say thanks to Prof Eric Buch
(NEPAD Health Advisor), who requested data from the industry
on harmonisation issues, which led to the development of this
study.
Impact of regulatory requirements on medicine registration
37
Southern Med Review Vol 5 Issue 1 July 2012
Conflict of interest
None of the authors have any conflicts of interest that are
directly relevant to the content of this study. The Department
of Pharmacoepidemiology and Clinical Pharmacology, Utrecht
Institute for Pharmaceutical Sciences, employing Aukje Mantel-
Teeuwisse has received unrestricted research funding from the
Netherlands Organisation for Health Research and Development
(ZonMW), the Dutch Health Care Insurance Board (CVZ), the
Royal Dutch Pharmacists Association (KNMP), the EU Innovative
Medicines Initiative (IMI), the EU 7th Framework Program (FP7),
the Dutch Medicines Evaluation Board, the Dutch Ministry of
Health and industry (including GlaxoSmithKline and Pfizer). Kirti
Narsai is permanently employed by PIASA. Abeda Williams is
permanently employed by Janssen.
Funding Source
No sources of funding were used to assist in the preparation of
this study.
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Impact of regulatory requirements on medicine registration
