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Pharmaceutical Industry Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward

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Introduction The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to collaborate and conduct joint reviews of applications. One such collaborative medicines registration initiative is the Southern African Development Community ZaZiBoNa, established in 2013. A recent study was carried out with the nine active member regulatory authorities of the ZaZiBoNa to determine their views on its operational effectiveness and efficiency. Having obtained the authorities’ views, the aim of this study was to evaluate the effectiveness and efficiency of the current operating model of the ZaZiBoNa initiative including the challenges it faces as well as identifying opportunities for improvement from the applicants’ perspective. Methods Applicants who had submitted registration/marketing authorisation applications for assessment under the ZaZiBoNa initiative during 2017–2021 were recruited into the study. Data was collected in 2021 using the Process, Effectiveness and Efficiency rating questionnaire (PEER-IND) developed by the authors. The questionnaire was completed by a representative responsible for ZaZiBoNa submissions in each company. Results The pharmaceutical industry was of the view that the ZaZiBoNa initiative has achieved shorter timelines for approval of medicines, resulting in increased availability of quality-assured medicines for patients in the SADC region. Harmonisation of registration requirements and joint reviews have reduced the workload for both the pharmaceutical industry and the regulatory authorities. Some of the challenges identified were the lack of a centralised submission and tracking system, and the lack of information for applicants on the process for submission of ZaZiBoNa dossiers/applications in the individual countries, including contact details of the focal person. The establishment of a regional unit hosted in one of the member countries to centrally receive and track ZaZiBoNa dossiers/applications was identified as the best strategy for moving forward in the interim with the long-term goal being the establishment of a regional medicines authority. Conclusion There was consensus between the pharmaceutical industry and the regulatory authorities as to the way forward to improve the effectiveness and efficiency of the ZaZiBoNa initiative. Implementation of the recommendations identified in this study will lead to enhanced regulatory performance.
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ORIGINAL RESEARCH
published: 25 April 2022
doi: 10.3389/fmed.2022.898725
Edited by:
Steffen Thirstrup,
NDA Advisory Services Ltd.,
United Kingdom
Reviewed by:
Christine Årdal,
Norwegian Institute of Public Health
(NIPH), Norway
Birka Martha Luise Lehmann,
University of Bonn, Germany
*Correspondence:
Stuart Walker
swalker@clarivate.com
Specialty section:
This article was submitted to
Regulatory Science,
a section of the journal
Frontiers in Medicine
Received: 17 March 2022
Accepted: 01 April 2022
Published: 25 April 2022
Citation:
Sithole T, Mahlangu G, Walker S
and Salek S (2022) Pharmaceutical
Industry Evaluation of the
Effectiveness and Efficiency of the
ZaZiBoNa Collaborative Medicines
Registration Initiative: The Way
Forward. Front. Med. 9:898725.
doi: 10.3389/fmed.2022.898725
Pharmaceutical Industry Evaluation
of the Effectiveness and Efficiency of
the ZaZiBoNa Collaborative
Medicines Registration Initiative: The
Way Forward
Tariro Sithole1,2, Gugu Mahlangu2, Stuart Walker1,3*and Sam Salek1,4
1School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom, 2Medicines Control Authority
of Zimbabwe, Harare, Zimbabwe, 3Centre for Innovation in Regulatory Science (CIRS), London, United Kingdom, 4Institute
for Medicines Development, Cardiff, United Kingdom
Introduction: The common technical document (CTD) format harmonised the
requirements for the registration of medicines, which had traditionally differed from
country to country, making it possible for countries to collaborate and conduct joint
reviews of applications. One such collaborative medicines registration initiative is the
Southern African Development Community ZaZiBoNa, established in 2013. A recent
study was carried out with the nine active member regulatory authorities of the
ZaZiBoNa to determine their views on its operational effectiveness and efficiency. Having
obtained the authorities’ views, the aim of this study was to evaluate the effectiveness
and efficiency of the current operating model of the ZaZiBoNa initiative including
the challenges it faces as well as identifying opportunities for improvement from the
applicants’ perspective.
Methods: Applicants who had submitted registration/marketing authorisation
applications for assessment under the ZaZiBoNa initiative during 2017–2021 were
recruited into the study. Data was collected in 2021 using the Process, Effectiveness
and Efficiency rating questionnaire (PEER-IND) developed by the authors. The
questionnaire was completed by a representative responsible for ZaZiBoNa submissions
in each company.
Results: The pharmaceutical industry was of the view that the ZaZiBoNa initiative has
achieved shorter timelines for approval of medicines, resulting in increased availability of
quality-assured medicines for patients in the SADC region. Harmonisation of registration
requirements and joint reviews have reduced the workload for both the pharmaceutical
industry and the regulatory authorities. Some of the challenges identified were the
lack of a centralised submission and tracking system, and the lack of information for
applicants on the process for submission of ZaZiBoNa dossiers/applications in the
individual countries, including contact details of the focal person. The establishment
of a regional unit hosted in one of the member countries to centrally receive and
track ZaZiBoNa dossiers/applications was identified as the best strategy for moving
forward in the interim with the long-term goal being the establishment of a regional
medicines authority.
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Sithole et al. ZaZiBoNa Industry Evaluation
Conclusion: There was consensus between the pharmaceutical industry and the
regulatory authorities as to the way forward to improve the effectiveness and efficiency of
the ZaZiBoNa initiative. Implementation of the recommendations identified in this study
will lead to enhanced regulatory performance.
Keywords: ZaZiBoNa, regulatory harmonisation, work sharing, effectiveness, efficiency, common technical
document (CTD)
INTRODUCTION
Medicines and other medical products undergo a rigorous review
to ensure compliance with quality, safety, efficacy and local
requirements before they are registered in most countries (1,
2). Other factors such as compliance of the manufacturing
site(s) with current good manufacturing practices (cGMP)
and compliance of product samples with specifications are
considered before a medical product is registered by national
medicines regulatory authority (1). Traditionally, requirements
for registration differed from country to country, which meant
that applicants had to compile a new data set each time they
wanted to submit their dossiers/applications for registration
(2). This presented many challenges in an industry often
characterised by multinational operations. The International
Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) common
technical document (CTD) format, which was finalised in
the early 2,000s, addressed this challenge by harmonising the
technical requirements for new drug applications (2). The CTD
format is made up of 5 modules. Module 1 is region specific;
for example, application forms and labels; and it has been
acknowledged from the onset that module 1 requirements will
be different from country to country. Modules 2–5 are the same
across all regions. Module 2 is for overviews and summaries of
modules 3–5, module 3 for quality, module 4 for non-clinical
study reports and module 5 for clinical study reports (Figure 1)
(24). Development of the CTD format is a powerful example of
the benefits that can come out of collaboration between regulators
and the pharmaceutical industry.
Regulatory Harmonisation in Africa
The CTD format is now used by other countries that are not
ICH members (5). The World Health Organization (WHO)
prequalification “Guidelines for submission of documentation
for a multisource (generic) finished product and preparation
of product dossiers in common technical document format”
(6) have been adapted or adopted for use by many low- and
middle-income countries in the last decade. The CTD format has
facilitated harmonisation of medicines registration requirements,
work sharing and joint reviews on the African continent (7,8)
Abbreviations: AMRH, African Medicines Regulatory Harmonisation Initiative;
CTD, common technical document; EAC, East African Community; ECOWAS,
Economic Community of West African States; PEER-IND, Process, Effectiveness
and Efficiency Rating questionnaire for industry; SADC, South African
Development Community; SQAM, STANDARDISATION, Quality Assurance,
Accreditation and Metrology; SRA, stringent regulatory authority; WHO, World
Health Organization.
as is the case in other emerging markets (5,9). Established in
2009, the African Medicines Regulatory Harmonisation Initiative
(AMRH) is the driving force behind harmonisation of medicines
regulation in Africa (10). The AMRH works through the five
regional economic blocks recognised by the African Union, for
example, Southern African Development Community (SADC),
East African Community (EAC) and the Economic Community
of West African States (ECOWAS) (11).
ZaZiBoNa Collaborative Medicine
Registration Initiative
ZaZiBoNa is a collaborative medicines registration initiative in
the SADC region established in 2013 and formally endorsed
by the SADC Health Ministers in 2014 (7). All 16 SADC
countries, Angola, Botswana, Comoros Islands, Democratic
Republic of Congo, Eswatini, Lesotho, Madagascar, Malawi,
Mauritius, Mozambique, Namibia, Seychelles, South Africa,
United Republic of Tanzania, Zambia, and Zimbabwe (12),
participate in the initiative as either active or non-active members
(7). As at December 2021, 333 dossiers/applications had been
assessed under the ZaZiBoNa initiative with a median time to
recommendation of 12 months (13), which is much shorter than
the timelines reported by some of the participating countries for
their national procedures (14). Although some feedback on the
performance of the initiative has been sought from manufactures
through stakeholder meetings in the past, there has not been a
comprehensive and structured evaluation of the work-sharing
programme for its future direction. Therefore, a study was carried
out with the nine active members (regulatory authorities) of
the ZaZiBoNa work-sharing initiative to determine their views
on its operational effectiveness and efficiency (7). The aim of
this study was to evaluate the effectiveness and efficiency of the
current operating model of the ZaZiBoNa initiative including
the challenges it faces as well as identifying opportunities for
improvement from the perspective of applicants.
STUDY OBJECTIVES
The Study Objectives Were to
1. Obtain the views of the applicants of the ZaZiBoNa
initiative about the performance of the programme to date
2. Identify the challenges experienced by individual
applicants since the inception of the ZaZiBoNa initiative
3. Determine the strengths and weaknesses of the initiative
4. Identify the ways for improving the performance of the
work-sharing programme
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FIGURE 1 | The Common technical document triangle (4).
5. Envisage the strategy for moving forward
MATERIALS AND METHODS
Study Participants
Twenty-three applicants who had submitted
registration/marketing authorisation applications for both
generic and innovator products to the ZaZiBoNa initiative
during the period 2017–2021 were identified and invited to
participate in the study. Nineteen out of the 23 applicants
responded with completed questionnaires, translating to a
response rate of 83%. Applicants who submitted applications
for registration of generic medicines manufactured outside of
the SADC region will be referred to as Generics (Foreign) in this
report. Applicants who submitted applications for registration
of generic medicines manufactured within the SADC region will
be referred to as Generics (Local). Applicants who submitted
applications for registration of innovator medicines will be
referred to as Innovator. There were no locally manufactured
innovator medicines submitted to ZaZiBoNa in the period under
review (2017–2021).
Data Collection
Data were collected in September 2021 using the Process,
Effectiveness and Efficiency rating questionnaire for industry
(PEER-IND) developed by the authors. The questionnaire
was completed by a representative responsible for ZaZiBoNa
submissions in each company. The questionnaire comprised
five sections under the headings; Demographics, Benefits of
the ZaZiBoNa initiative, Challenges of the ZaZiBoNa initiative,
Improving the performance (effectiveness and efficiency) of
the work-sharing programme and Envisaging the strategy
for moving forward.
To examine the applicability and practicality of the PEER-IND
questionnaire, it was piloted with five applicants in August 2021
prior to undertaking the main study. Subsequently, an additional
questionnaire was completed by all participants to establish the
content validity and relevance of the PEER-IND questionnaire,
Ethics Committee Approval
The study was approved by the Health, Science,
Engineering and Technology ECDA, University of
Hertfordshire, United Kingdom [Reference Protocol number:
LMS/PGR/UH/04350].
RESULTS
For the purpose of clarity, the results are presented in five parts,
matching the questionnaire sections: Part I—Demographics; Part
II—Benefits of the ZaZiBoNa initiative; Part III—Challenges of
the ZaZiBoNa initiative; Part IV—Improving the performance
of the work-sharing programme; and Part V—Envisaging the
strategy for moving forward.
Part I—Demographics
The study respondents’ age ranged from 33 to 59 years, with
a range of regulatory experience from 5 to 30 years. Eleven
of the respondents were female and 8 were male. Study
participants were classified according to product portfolio and
location of manufacturing site. Fifteen (79%) were foreign generic
pharmaceutical companies, one (5%) was a local manufacturer
of generics and three (16%) were innovator pharmaceutical
companies. Of the 333 dossiers/applications assessed as at
31 December 2021, 94% were generics submitted by foreign
companies, 5% were new active substances submitted by
innovator companies and 1% were generics submitted by
the local company.
Part II—Benefits of the ZaZiBoNa
Initiative
Benefits of the ZaZiBoNA Initiative
Information sharing among regulators (16/19), harmonisation of
registration requirements across the region (15/19) and shorter
timelines for approval (14/19) were identified as the top three
benefits of the ZaZiBoNa initiative by the majority of the
applicants. However, of note is that less than one third of the
applicants believed that the operating model was clear (5/19) or
that self-funding by countries created a sustainable resource base
for the initiative (3/19) (Figure 2).
Benefits of the ZaZiBoNa Initiative to Applicants
The majority of applicants (16/19) viewed the savings of time and
resources as a benefit of the initiative, as they received the same
list of questions from multiple countries, enabling compilation
of a single response package (Figure 3). In addition to this, a
large number of applicants (14/19) believed that the burden of
compiling several dossiers for different countries was reduced as
under ZaZiBoNa they only compiled one dossier (modules 2–5)
for submission to multiple countries. Access to various markets
at the same time (13/19) and shorter timelines for approval
compared with that of the individual countries (11/19) were also
identified as benefits to applicants, although some applicants were
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FIGURE 2 | Benefits of the ZaZiBoNa initiative according to pharmaceutical industry respondents.
of the view that ZaZiBoNa timelines of approximately 12 months
were comparable to the national timelines for some countries
who had improved their timelines in the last 2–3 years.
Benefits of the ZaZiBoNa Initiative to Patients
Increased availability of medicines (15/19) and quicker access
to quality-assured medicines (14/19) were identified as the
benefits of the ZaZiBoNa initiative to patients by the majority
of applicants. This was attributed by some applicants to
improved commercial viability in otherwise under-resourced
territories, resulting from the acceptance/supply of a harmonised
medicinal product across the region. However, only 2 out of
the 19 applicants believed that the initiative resulted in reduced
prices for medicines.
Part III—Challenges of the ZaZiBoNa
Initiative
Overall Challenges of the ZaZiBoNa Initiative
The major challenges of the ZaZiBoNa initiative were identified
as the lack of centralised submission and tracking (18/19),
differences in regulatory performance of the countries (13/19),
lack of ability to mandate central registration (12/19) and
dependence on the countries’ processes for communication with
applicants (12/19). Additional challenges highlighted were the
failure by some countries to adhere to the 90 working days set
for registration after the ZaZiBoNa recommendation, difficulty
following up on dossiers/applications in some countries as there
was no clear ZaZiBoNa contact person and the lack of an
overall central person in ZaZiBoNa to submit complaints when
individual countries were uncooperative.
Challenges for Applicants Submitting Applications to
the ZaZiBoNa Initiative
The top two challenges faced by applicants in the view of
the respondents were lack of information on the country and
ZaZiBoNa websites about the process, milestones, timelines
and pending and approved medicinal products (15/19) and
the differences in time to implementation of ZaZiBoNa
recommendations by member countries (14/19). Additional
challenges identified by a majority of the applicants were differing
labelling requirements in participating countries (11/19), lack
of clarity about the process for submission and follow-up
in each country (10/19) and low motivation to use the
ZaZiBoNa route as other review routes now used by individual
countries such as reliance on stringent regulatory authority
(SRA) approvals or approvals by other SADC countries were
faster (10/19) (Figure 4). The lack of alignment resulting
in some of the ZaZiBoNa member countries being more
stringent than others was perceived to put smaller companies
at a disadvantage compared with larger established companies.
Applicants also expressed frustration at having to duplicate
efforts in completing WHO forms, which are currently used for
ZaZiBoNa and national forms; for example, WHO vs. national
Quality Information Summary and Quality Overall Summary.
Industry’s Views of the Challenges Faced by
Regulators
Industry identified some challenges faced by regulators:
submission of dossiers and query responses at different
times in the member countries, making it difficult to initiate
harmonised assessment;
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FIGURE 3 | Benefits of the ZaZiBoNa initiative to applicants according to pharmaceutical industry respondents.
FIGURE 4 | Challenges to the ZaZiBoNa initiative for applicants according to pharmaceutical industry respondents.
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different internal processes in each of the authorities
leading to dissimilar times for adoption of
recommendations and processing of query letters and
registration certificates;
inadequate infrastructure and information technology (IT)
system and resources;
unavailability of reliance-related documentation from
Stringent Regulatory Authorities (SRAs) for WHO
facilitated SRA reviews;
difficulty in sharing additional information provided by
applicants during submission of responses to respective
authorities;
facilitating various views during the review of a single
application by all participating countries;
limited capacity for the review of bio-therapeutics by some
authorities;
limited number of assessors with adequate skills) available
for the ZaZiBoNa process; and
lengthy assessments and queries due to the combined
process and lack of a dedicated team to review the
ZaZiBoNa applications.
Part IV—Improving Performance
(Effectiveness and Efficiency)
Improving the Effectiveness of the ZaZiBoNa Initiative
The following approaches, namely minimising the need for
country-specific documents (16/19), making publicly available
any information that might help applicants in managing their
submissions such as document templates, lists of Q&As, timelines
and milestones, disclosure of internal standard operating
procedures (13/19), use of risk-based approaches such as
reliance pathways and engagement (13/19) and interaction
with stakeholders (13/19) were selected as the top ways
to improve effectiveness of the initiative by the industry.
Applicants proposed that having clear communication as to
whether a dossier/application has been accepted into the
ZaZiBoNa process, the availability of contact details of the
focal person in each respective country to enable follow-up of
pending dossiers/applications and centralising submission were
additional measures that would improve the effectiveness of the
initiative (Figure 5).
Improving the Efficiency of the ZaZiBoNa Initiative
Applicants selected improved central tracking of ZaZiBoNa
dossiers/applications (17/19) and a centralised system for the
submission of applications and communication with applicants
(17/9) as the top ways to improve the efficiency of the initiative for
applicants. Also identified as contributing to improved efficiency
were specific and clear requirements made easily available to
applicants (15/19) and compliance with target timelines by
measuring and monitoring each milestone in the review process
(13/19) (Figure 6).
Part V—Strategies for Moving Forward
The majority of applicants (15/19) were of the view that the
establishment of a regional unit hosted in one of the member
countries to centrally receive and track ZaZiBoNa applications
was the best strategy moving forward in the interim. The
unit would be responsible for allocating work, apportioning
the applicable fees to countries, tracking of applications and
communication with applicants. The majority of applicants
(12/19) were also of the view that to continue with the current
operating model was the least effective strategy.
Fifteen out of 19 applicants were of the view that if it were
legally possible, the establishment of a SADC regional medicines
authority would be the best strategy to address the challenges
and areas requiring improvement in the initiative. However,
it was acknowledged by some of the applicants that immense
legal and administrative hurdles exist in the SADC setting; for
example, lack of harmonisation in the regional dossier sections, as
well as differences in country-specific registration requirements,
which will need to be addressed if a regional authority is to
be established. An example of this is the requirement of the
South African Health Products Regulatory Authority (SAHPRA)
that comparative dissolution studies should be conducted
between an SRA oral formulation vs. the local test medicinal
product to demonstrate equivalence in three different dissolution
media is unique to SAHPRA and different to all other ZaZiBoNa
members. A few of the applicants (3/19) were not in support of
the establishment of a SADC regional medicines authority, as
some of these felt that it would increase the operating costs of the
entire evaluation process, which would affect them in the end.
DISCUSSION
The results of this study show that applicants perceive that
there has been a high degree of success and benefit from
the ZaZiBoNa initiative for applicants, patients and regulators.
A similar study was conducted with regulators (15) and the
responses compared. Regulators and industry commonly agreed
that information sharing among regulators and harmonisation of
registration requirements across the region were the top benefits
of the ZaZiBoNa initiative. There was agreement too that as a
result, the initiative has saved industry the time and resources
spent compiling submissions and responses to queries. Both
regulators and pharmaceutical industry were of the view that
the initiative has resulted in greater access to quality-assured
medicines by patients, although there was a difference in opinion
regarding the time that this is taking. A number of applicants
were of the view that ZaZiBoNa resulted in shorter timelines,
while only a minority of regulators believed that this was a
benefit (15). Further investigation is required to understand why
the initiative is not resulting in reduced prices of medicines for
patients, since both regulators and industry acknowledge that
time, resources and the effort required to get medicines approved
has been reduced.
While the successes and benefits of the ZaZiBoNa initiative
have been examined in this study, it is apparent that there is
now a need to review the operating model in order to address
the challenges that have been identified to make it more effective
and efficient. Views of the regulators (15) and industry were
compared and there was agreement on the challenges such as
lack of information for applicants on country websites, failure
by applicants to meet deadlines for submission of responses,
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FIGURE 5 | Improving the effectiveness of the ZaZiBoNa initiative according to pharmaceutical industry respondents.
FIGURE 6 | Improving the efficiency of the ZaZiBoNa initiative according to pharmaceutical industry respondents.
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inadequate resources, an unclear operating model and differing
performance by participating regulatory authorities.
Interestingly, only a minority of the regulators and industry
were of the view that self-funding by countries created a
sustainable resource base for this initiative; therefore, there is still
a need for partner support or other sources of funding at present.
This is supported by studies in the literature highlighting the
inadequacy of resources currently available to authorities in low-
to middle-income countries (1620). Challenges highlighted by
the industry but not identified in the regulators study (15) are the
difficulties faced by applicants when they need to follow up on
pending dossiers/applications or seek arbitration in situations in
which individual authorities were uncooperative. The challenges
identified in this study are not unique to this initiative, as
they have been identified for other regions such as the East
African Community, with applicants indicating that the goal of
harmonisation, which was to ensure quicker access to quality-
assured medicines was not always being met (21). Addressing the
challenges identified in this study presents a unique opportunity
for ZaZiBoNa to re-engineer its operating model, thus ensuring
that the initiative remains competitive when compared with the
other routes available for registration of medicines.
The removal of country-specific requirements was identified
in both this and the regulators study (15) as one of the best ways
to improve effectiveness and efficiency. Authorities in the SADC
region now require submission of the dossier in CTD format;
however, there are some country-specific requirements identified
in this study such as bioequivalence, labelling and local Quality
Information Summary and Quality Overall Summary that still
impede harmonisation efforts and this is consistent with findings
from other studies in the literature (15,22). There is now a need
for countries to make a deliberate effort to collectively review
their legislation in order to include provisions that facilitate the
harmonisation of the registration and labelling requirements for
medicinal products in the SADC region.
Although the ZaZiBoNa initiative has been in operation for8
years, the process for submission in some countries remains
unclear to applicants (15). This, in addition to a number of
other challenges identfied in this study such as failure by
some countries to register medicines and issue GMP certificates
within the set timelines after a ZaZiBoNa recommendation, can
be attributed to the participating authorities having differing
capacities (14,18). Centralised submission and tracking were
therefore proposed by both regulators and industry as ways
to improve the effectiveness and efficiency of this initiative.
This can be achieved through the development of a regional
unit hosted in one of the member countries to coordinate
submissions. A proposal made by industry, but not identified
by regulators, was the need to implement a system that would
allow applicants to submit an “expression of interest” to have
their dossiers/applications assessed under ZaZiBoNa. This would
enable the regulators to adequately plan and allocate resources as
well as ensure that applicants are informed from the outset as to
whether their dossiers/applications have been accepted for review
under ZaZiBoNa. At present, some applicants only become aware
that their dossier/application will be reviewed under ZaZiBoNa
months after submission. Although some of the participating
countries have information on the ZaZiBoNa process on their
websites and the contact details of the focal person are known,
this is not the case in all the countries and this detracts from the
initiative’s effectiveness and efficiency.
Way Forward
In the long term, the establishment of a regional medicines
authority was proposed as a strategy for moving forward. This
is not unique to SADC and has also been proposed for other
harmonisation initiatives (21,23,24). To do this, a binding
memorandum of understanding should be developed mandating
the establishment of the regional medicines authority. A similar
model has been implemented in the Standardisation, Quality
Assurance, Accreditation and Metrology (SQAM) Programme
in the Southern African Development Community (25). This
would ideally make it possible for a SADC-approved medicinal
product to be marketed in all the SADC countries. Issues such
as the need to strengthen pharmacovigilance systems and to have
agreement on the use of labelling that is in the three official SADC
languages, English, Portuguese and French, should be considered
before implementation as these are important for patient safety.
In addition, the issue concern of increased costs to applicants that
was raised by a few of the applicants who were not in support of
this proposal should also be taken into consideration.
Key recommendations to improve effectiveness and efficiency
of ZaZiBoNa work-sharing initiative include:
Information for applicants—Full information on the
ZaZiBoNa process including contact details of the focal
person, timelines and milestones as well as approved
medicinal products should be published on the website of
every participating authority and ZaZiBoNA.
Submission procedures—The initiative should introduce
expression of interest forms, which will be completed by
applicants prior to submission of dossiers. Communication
of acceptance for assessment under the ZaZiBoNa initiative
or otherwise should be made within a defined period from
the date of submission.
Information management systems—The initiative should
use automated systems to enable the online tracking of
submissions through all the stages of review including
information on the meetings at which dossiers/applications
are discussed. Applicants should also be able to track their
dossiers/applications using the same system.
Product life-cycle management—The initiative should
establish a process for review of post approval changes.
Variation requirements should be harmonised so that one
application can cater for all markets.
Reliance—The WHO-facilitated SRA procedure for
ZaZiBoNa has yielded significant results for some
applicants and should be promoted and used for more
medicinal products.
Centralised submission, tracking and communication
system—As an interim measure, a regional unit hosted
in one of the member countries should be piloted to
centrally receive, track and coordinate ZaZiBoNa dossier
submissions. This will address the various challenges
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faced by the industry with the current operating model
such as differences in the time to implementation of the
ZaZiBoNa recommendations for assessments and GMP
inspections and the lack of a specified person/office to
escalate matters in cases in which applicants have challenges
with participating countries.
Regional medicines authority—In the long term, a binding
memorandum of understanding should be developed
mandating the establishment of a regional medicines
authority. This would be similar to the model employed
for the SQAM programme in the Southern African
Development Community. This would ideally make it
possible for a SADC-approved medicinal product to be
marketed in all the SADC countries. In the meantime,
countries should make a deliberate effort to collectively
review their legislation, guidelines and processes in order to
truly harmonise the registration and labelling requirements
for medicinal products in the SADC region.
Study Limitations
The scope of this study was limited to the ZaZiBoNa initiative’s
process and operating model. In future, it would be helpful to
get quantitative data to support these views including the actual
metrics of the time taken to register the medicinal products in
the individual countries after a ZaZiBoNa recommendation. The
status of commercialisation and pricing of the medicinal products
in the individual countries as well as the factors influencing this
could be the subject of a future study.
CONCLUSION
This study has enabled an improved understanding of the
performance of the ZaZiBoNa initiative from the applicants’
perspective. Applicants have highlighted the benefits of this
initiative as well as some of the challenges. Addressing these
challenges will lead to enhanced regulatory performance.
DATA AVAILABILITY STATEMENT
The raw data supporting the conclusions of this article will be
made available by the authors, on request.
AUTHOR CONTRIBUTIONS
TS designed the study, collected, analysed the data, and
wrote the first draft of the manuscript. GM interpreted the
results and reviewed subsequent drafts of the manuscript.
SW and SS designed the study, interpreted the results,
and reviewed subsequent drafts of the manuscript. All
authors contributed to the article and approved the
submitted version.
FUNDING
We wish to acknowledge the Jenny Greenhorn Memorial
Scholarship for supporting the Ph.D. project. This research was
also supported by an unrestricted grant from the Bill and Melinda
Gates Foundation.
ACKNOWLEDGMENTS
We wish to thank the following companies who completed
the questionnaire; (1) Cadila Pharmaceuticals Limited, (2)
Cipla Quality Chemicals Industries Limited, (3) Cospharm
Investments (Pty) Ltd., (4) Emcure Pharmaceuticals Limited,
(5) Eurolab (Pty) Ltd., (6) Equity Pharmaceuticals (Pty)
Ltd., (7) Hetero Labs Limited, (8) Innovata Pharmaceuticals
Ltd., (9) Laurus Labs Limited, (10) Lupin Limited, (11)
Macleods Pharmaceutical Limited, (12) Mundipharma
(Pty) Ltd., (13)MSN Laboratories Private Limited, (14)
Mylan Investments (Pty) Ltd., (15) N2SA Limited, (16)
Roche Products (Pty) Ltd., (17) S Kant Healthcare
Ltd., (18) Umsebe Healthcare, and (19) Varichem
Pharmaceuticals.
SUPPLEMENTARY MATERIAL
The Supplementary Material for this article can be found
online at: https://www.frontiersin.org/articles/10.3389/fmed.
2022.898725/full#supplementary-material
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Conflict of Interest: The authors declare that the research was conducted in the
absence of any commercial or financial relationships that could be construed as a
potential conflict of interest.
Publisher’s Note: All claims expressed in this article are solely those of the authors
and do not necessarily represent those of their affiliated organizations, or those of
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this article, or claim that may be made by its manufacturer, is not guaranteed or
endorsed by the publisher.
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article distributed under the terms of the Creative Commons Attribution License
(CC BY). The use, distribution or reproduction in other forums is permitted, provided
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