Optimising procedure management for marketing authorisation of veterinary medicines in Eastern Africa

Timely and effective marketing authorisation of veterinary medicines requires a combination of rigorous scientific evaluation and efficient management of procedures.  In line with GALVmed’s role in implementing the AgResults Foot and Mouth Disease (FMD) Vaccine Challenge Project in Eastern Africa, GALVmed has worked with the Secretariat of the East African Community (EAC) to support National Regulatory Authorities (NRA) in the region to build capability in marketing authorisation of FMD and other vaccines.  A first workshop was organised in November 2020 that focussed on the technical requirements for authorisation.  A second workshop took place in November 2022, looking at measures that NRA could take to optimise the management of marketing authorisation procedures so that authorisations are evaluated and issued in a timely manner.  The Veterinary Medicines Directorate in the United Kingdom (UKVMD) provided expertise to both workshops based on their experience as an NRA that has extensive knowledge in authorisation of FMD and other vaccines, both at national level in the UK and in cooperation with other NRA.

Key workshop outcomes

This workshop focused on optimising procedure management for marketing authorisation of veterinary medicines in Eastern Africa.  Although the main focus of the workshop was on marketing authorisation of veterinary vaccines, the same principles of effective procedure management apply to all types of veterinary medicines, and so the conclusions and recommendations apply equally to both veterinary pharmaceuticals and vaccines. 

National marketing authorisation procedures operate in all countries within Eastern Africa that have a functional regulatory authority.  Member countries of the EAC also operate a mutual recognition (MR) procedure.  Ultimately, MR procedures rely on national procedures for issuing a national marketing authorisation certificate following agreement on a harmonised summary of product characteristics (SPC). The workshop therefore examined procedure management of both national and MR procedures and the interface between them.

Approach

Participants in the workshop consisted of experts from NRA responsible for managing marketing authorisation procedures, particularly MR procedures, for veterinary products within their agency.  Over the course of two days experts explored, with the organisers and invited experts, those aspects of procedure management that worked well within and between agencies in the region and aspects that could be improved.  A representative of the global animal health industry association HealthforAnimals gave a presentation that summarised feedback from local industry on their perceptions of procedure management in the region.

Key messages arising from the workshop

  • Companies that have used the MR procedure feel it generally works well and appreciate the ability to obtain marketing authorisation in multiple countries through a single procedure.  The role and activity of the MRP Coordinator was considered particularly helpful.
  • NRA are encouraged to make information on the technical and administrative requirements for marketing authorisation procedures more readily available to applicants, particularly in the case of the MRP.  It can be difficult for applicants to understand all of the requirements that apply in different countries, particularly where these differ between countries such as the arrangements for dossier submission, payment of fees and submitting samples for testing.  Where not already done, NRA should publish their requirements online and make use of the MRP ‘one-pager’ information sheet being prepared by the EAC Secretariat.
  • Adherence to timelines is frequently poor and delays may arise due to failure to adhere to deadlines by NRA, Local Technical Representatives (LTR), or applicants.  When accepting the role of Reference Country (RC) or Concerned Country (CC), NRA should ensure that they have sufficient resource to process applications in a timely manner.
  • Applicants currently find it difficult to obtain information on the previous experience, and performance, of NRA when performing the role of RC or CC.  NRA, possibly working the Coordination Group on Mutual Recognition (CGMR), should make this information public to allow applicants to make informed choices of NRA to act as RC or CC for their applications.
  • Communication with applicants on the progress of applications through the evaluation procedure is highly variable.  Some countries already have online systems allowing applicants to track their applications whilst applicants in other countries reported difficulty in monitoring progress of their applications.  NRA are encouraged to improve tracking of applications and communication with applicants.  NRA vary widely in the extent to which they rely on manual process or on IT solutions and on the resources available for management of procedures. Ways to promote exchange of experience and best practice between those agencies that already operate online tools and those that are developing them should be explored to accelerate the introduction of IT solutions and avoid unnecessary duplication of effort.
  • The LTR acts as the applicant’s representative with the NRA and plays a key role in the smooth functioning of the MR procedure.  The performance of LTR varies widely, and a poorly performing LTR can slow or halt an ongoing procedure.  Whilst managing LTR is the responsibility of the applicant, NRA need to consider ways to help applicants to improve or replace poorly performing LTR and to promote the use by applicants of LTR that are known to be effective.  Guidance from NRA on how LTR can best fulfil their role would be useful.
  • Participants were invited to explore the interest within their agency in trialling a self-assessment and evaluation tool developed by the UKVMD.  This tool provides a framework which agencies can use to evaluate the effectiveness of their regulatory functions and to develop action plans in areas identified for improvement.
  • Participants considered that a follow-up in-person workshop would help them develop action plans that address the areas for improvement identified by the current workshop.
  • The findings of the workshop should be brought to the attention of Heads of Agency to raise awareness of the benefits that the MR procedure is bringing to applicants and to agencies in the region, and of the areas that have been identified for further improvement.
  • The CGMR plays a key role in ensuring the smooth operation of MR procedures.  The group should be encouraged to play a greater role in fostering best practice among NRA by including process improvement as a standing item on their agenda and by promoting interchanges between agencies that increase sharing of work and knowledge.

This blog was written by the AgResults FMD Vaccine Challenge Project team.

Tackling small livestock diseases

Almost every small-scale farming family in low- and middle-income countries owns small livestock – whether chickens, ducks, rabbits, sheep, goats or pigs. While small livestock provide nutrient-rich food, they are also considered a form of a savings account and often referred to as “ATMs” because they are a convenient source of cash.

Small livestock are also a pathway out of poverty and source of economic and gender empowerment for women and young people, especially in rural areas.

And yet for millions of small-scale producers, these very important assets are threatened by diseases. A chicken business can be decimated in a blink of an eye by Newcastle Disease (ND) which can kill up to 90% of the poultry. Similarly, Contagious Caprine pleuropneumonia (CCPP) is one of the most severe diseases of goats, and morbidity rate may reach 100% and the mortality rate can be as high as 80%. Peste des petits ruminants (PPR) can cause heavy losses, especially in naïve herds (up to 80%), and African Swine Fever, for which there is no vaccine, has a mortality rate which can be as high as 100%.

These are some of the small livestock diseases that GALVmed and partners are currently tackling. For some of these diseases, there already exist control tools such as a vaccine; for others, not yet. But even for those with vaccines, there are still challenges that impede their wide usage by small-scale producers. Together with our partners, we are continuously researching appropriate technologies to increase their uptake. For example, GALVmed has been working with partners to explore co-administration of the ND-Fowlpox vaccines through a non-invasive, needle free route, using feather follicles for the Fowlpox (FP) and the Newcastle disease vaccine via eye. This research has demonstrated to be safe and to elicit immunity in two field studies, one in Tanzania the other in Nepal. These findings are important to appropriately trained small-scale backyard poultry farmers as well as to paraprofessionals and community health workers helping to increase vaccine uptake and the control of both FP and ND in low- to middle-income countries.

GALVmed is also working with a commercial partner to develop a Small Ruminant Systemic Multivalent Vaccine addressing several major small ruminant diseases (CCPP, SGP, PPR), in a single combination vaccine. The multi-valent approach has the advantage to maximise disease coverage through distribution networks operating effective cold chains.

GALVmed has also previously worked with MCI Sante Animale in Morocco to develop a multivalent vaccine for Peste des petits ruminants (PPR)  and Sheep and Goat Pox (SGP) in sheep and goats. The two diseases affect many of the same animals in the same regions, and are not, in fact, easy to distinguish. Many farmers vaccinate against the more frequently occurring SGP, but not against the less common, but more deadly, PPR.

It is clear that multi-valent vaccines offer pragmatic and cost-effective disease control tools for the small-scale livestock keeper.

Alongside our partners, GALVmed will continue to explore various technologies to address diseases that threaten small livestock, to improve their health, increase their productivity and reduce their mortality, so that small-scale producers can benefit from their small livestock investments.

 This blog was written by Beatrice Ouma as part of the campaign “The advantage of small livestock”

Small livestock, big opportunities

Goats, sheep, pigs, chickens. These are some of the small livestock that are giving millions of people opportunities. Opportunities to build a house, buy clothes, secure their children’s education, or put food on the table. But the livestock are under threat from preventable diseases.

According to the Food and Agriculture Organization of the United Nations (FAO), smallholder farmers around the world produce about a third of the world’s food. With such an important role, it is essential that these farmers have access to affordable and high-quality veterinary products to keep their animals healthy and be able not only to address their basic needs, but also to help feed the world.

The value of small livestock, such as small ruminants or poultry, has been widely reported. Small stock provides small-scale producers with food, which contributes to nutrition security, creates employment opportunities, empowers women and young people (as they tend to care for and manage small animals), and overall bolsters households’ financials.

Binita is 18 years old and goat keeping is her family’s main support. “We do not have a farm, so goat keeping is our basic means of livelihood. All our household expenses are met with the money we earn from selling goats”.

At Malti’s house, she is responsible for the goats and sheep. Her husband is a casual labourer and the additional income gained from goat keeping helps them in “supporting their children’s education and other such expenses”.

Bitti, 21, takes care of the goats owned by the family. “The income is additional and helps us in taking care of additional expenses, such as the building of our house”, she claims.

Moses is a poultry business owner who was able to build a house for his family thanks to the benefits gained from his farm, which has grown from just a few chickens in 2013 to about 2,000. “My house is built with income from my chicken business. I am no longer renting. Even though I double a bit on crop farming, much of my income comes from my chicken business”, says Moses.

Read Moses’ full story here.

These are just a few of many stories by small-scale producers, who are experiencing the benefits of keeping small livestock.

At GALVmed, we understand the value of livestock, including small livestock. Through collaboration with different partners, we implement diverse programmes which ultimately aim at providing small-scale livestock producers with the medicines, tools as well as knowledge that they need to ensure their animals’ health and secure their livelihoods.

Some examples of these programmes are the Brucellosis vaccine prize, an initiative to develop a vaccine against Brucellosis in small ruminants, The GALVmed Hester South Asia Project, a programme supporting small-scale producers in Uttar Pradesh, Bihar and Nepal by making available the most needed veterinary products for their livestock and poultry,  and PREVENT, a project to boost poultry production in Africa through hatchery vaccination.

At least 1.3 billion people rely on animal agriculture for their livelihood and food security. By taking care of livestock, together with our partners, we are directly protecting humans, the environment, ensuring food safety and security, and contributing to improving the lives of the people who like Binita, Malti, Bitti or Moses, depend on livestock for their livelihoods.

This blog was written by Patricia Valdeón Noya as part of the campaign ”The advantage of small livestock”

East African Community Mutual Recognition Procedure: What is it and why is it important?

Obtaining approval to sell veterinary medicines in the market requires a marketing authorisation (licence) from the National Regulatory Authority in each country where the product is to be sold. In East Africa, this involves applying for a marketing authorisation separately in each country. This is often lengthy, resource-intensive, and unpredictable.

Since 2011, the East African Community (EAC) with support from GALVmed, AU-PANVAC (Pan African Veterinary Vaccine Centre of African Union) and HealthforAnimals (the global animal health industry association) has been implementing the EAC’s Mutual Recognition Procedure (MRP) system which allows applicants to apply simultaneously for licences in multiple countries. This saves time and allows countries and applicants to use their resources more efficiently. MRP increases the likelihood for the sustainable supply of quality registered veterinary medicines in the region.

The first licence under MRP was issued for a veterinary vaccine in October 2018. Since then, several applications, immunological and pharmaceutical, have been processed and are now authorised in multiple countries in the EAC. This has contributed to increased access to quality safe, efficacious veterinary medicines.

Numerous benefits

Apart from saving time and resources in the submission process, MRP has other benefits. For the National Regulatory Authorities (NRAs), some of the benefits include:

  • Increased efficiencies by avoiding duplication of effort
  • Increased likelihood of improved quality of dossier submitted
  • The approach builds trust between assessors and Good Manufacturing Practice (GMP) inspectors
  • Identical dossier is submitted to all   participating NRAs
  • Approved veterinary medicines have the same finished product specification and SPC across the region
  • For inexperienced and less resourced NRAs, have an opportunity to learn and benefit from the more experienced and resourced NRAs 

And benefits to the industry include:

  • One dossier format to all NRAs
  • One procedure with one set of questions agreed on by the Reference Country ant the Concerned Country/Countries and based on a specific time-line – a predictable process that enhances planning 
  • Harmonised release criteria
  • Harmonised label claims
  • Possibility of fewer field trials
  • Harmonised post marketing activities – variations and renewal times harmonised and granted/approved at the same time and hence rapid introduction of new veterinary medicines in the market

All these benefits translate to increased likelihood of sustainable supply of quality registered veterinary medicines to livestock producers in the region.

Current progress

Since being introduced, the MRP process has received submissions from seven (7) global and African companies. Several applications for immunological and pharmaceutical products have been processed and authorised in multiple countries in the EAC, and approval time has been reduced significantly to about 12 months.

The MRP initiative is set to expand to include veterinary pesticides and subsequently, veterinary medical devices. The goal of improving access to quality veterinary medicines in EAC region with limited regulatory capacity could be addressed through regulatory reliance.

Blog written by Adelaide Ayoyi

Using a Randomised Control Trial to study the impact of Newcastle Disease vaccine on poultry farmer welfare and livelihoods

In 2020, Oxford Policy Management (OPM) was contracted by GALVmed to implement an intervention and conduct an associated impact study on the adoption of a Newcastle Disease Vaccine (NDV) by small-scale poultry farmers in rural Tanzania in the districts of Chemba and Mbozi. The objective of the study is to quantify the causal effects that the delivery of NDV has on the “production, productivity, and livelihoods of small-scale producers (SSPs)”. The study involves two main activities:

  1. The design and implementation of an NDV intervention in selected SSP farming areas of Tanzania.
  2. The design and implementation of an experimental study to quantify the causal effects of the NDV intervention.

The impact study was designed as a randomised controlled trial (RCT) where the study sample was randomly split into one treatment group and one control group. The treatment group was offered and will continue to be offered the NDV intervention package. This group will be compared with a control group, who did not and will not receive the intervention package during the study. The control group will receive one round of the intervention after the study’s endline survey.

A baseline study was conducted between September and November 2021 and the endline survey is scheduled for September to November 2023. Further details on the RCT and its findings will be made available upon publication of the results.

Blog written by Lamyaa Al-Riyami

GALVmed discusses impact

Impact is an important topic for any philanthropic organisation and GALVmed is putting this topic front and centre of our agenda for 2022. The primary reason is that we are in the process of finalising and beginning to implement our ten-year strategy, and it is vitally important that we integrate the lessons we have learned so far and align on the topic of impact.

To kickstart this process, three workshops were held over the end of January and beginning of February 2022 with the aim to provide a common, organisational understanding of impact. We took a look at our record of impact and discussed some of the associated key lessons learned from the three main programmes GALVmed has delivered to date, namely the first and second Protecting Livestock, Saving Human Life programmes (PLSHL 1 and PLSHL 2), and the Veterinary Innovations Transforming Animal Health and Livelihoods programme (VITAL). These workshops constituted the first phase of a collective look at impact within the organisation.

A second phase is being led by the evaluation team, which operates under the Commercial Development and Impact department (CD&I) at GALVmed. Lasting eight weeks, the primary purpose is to collate further data, present findings to our donors and board, and most importantly, to implement actionable findings into the Commercial Development, Research and Development, Evaluation, and Enabling Environment programmes under the new strategy.

The key activities include taking lessons learned from previous programmes of work and considering the implications for new GALVmed projects and programmes, creating a theory of change for GALVmed at an organisational level, in which the GALVmed mission is clearly stated and pathways to impact explained, and linking impact to GALVmed’s overall assessment of organisational performance. Through this process we intend to identify our potential for impact in the new strategy as well as the key levers and drivers for change.

This blog was written by Katharine Tjasink

Using vignettes for gender research

Gender research can be used to understand community perceptions of social and gender norms. To better understand these perceptions in the context of poultry intensification, the International Livestock Research Institute (ILRI), in collaboration with GALVmed, recently carried out a rapid gender landscaping analysis in Tanzania, Nigeria, and Zimbabwe using a unique method – the vignette. The landscaping analysis was designed to inform the gender context underpinning the PRomoting and Enabling Vaccination Efficiently, Now and Tomorrow (PREVENT) project in these countries.

A fictitious story about a chicken-keeper named Amina is a tool for conversations about social norms

The vignette approach involves reading out a fictitious story involving a main protagonist in a focus group setting and leaving the end of the story blank for the group to comment on ‘what happens next’ as a tool for a conversation about social and gender norms. As the landscaping study was designed to understand community perceptions of women’s involvement in poultry intensification, the vignette in this study was of a chicken keeper named Amina, whose poultry business was flourishing. Amina’s husband approaches her and wants to discuss her business. Responses from the community as to what happened next ranged widely. The following are some examples:

Amina was talented in chicken keeping as she started before she was married and benefited from it. I believe her husband wanted to give her knowledge on the business as well as to congratulate her because what she does is beneficial to the family and the whole society.

– Woman in Tanzania.

There’s no mention on the story where Amina’s business takes a dwindling turn, but it is forever growing, which excites me a lot. So, when the husband wants to talk to Amina about her business, there’s an element of knowledge capacitation the husband wants to offer to her so the business grows to greater heights.

– Man in Zimbabwe.

Maybe the man is jealous she is doing better than him and not getting her attention and other men are eyeing her; she is getting more money. He might think maybe one day she will not be submissive to him. He is afraid.

– Woman in Nigeria.

Through the vignette, we were able to gather information about potential consequences from husbands, family members, and community members when a woman intensifies her poultry production at the expense of her care duties. This includes responsibilities to the family, children, community, or breaking social norms such as speaking to male customers at night. Such consequences include shaming, social ostracization, gossip, jealousy, marital conflict, possibly even domestic violence, or divorce. While support from a husband and family members can lead to growth of the business, as the husband becomes more involved, there is a question about whether women’s ability to control resources and benefits diminishes.

The results of this study raise some interesting questions for the PREVENT project and the gender consequences of poultry intensification. GALVmed will be using these findings to inform a gender intentional approach to understanding, tracking, and communicating the gendered effects of the project.

This blog was written by Katharine Tjasink and co-authored by Zoë Campbell (ILRI)

Learning lessons at GALVmed

The collection and analysis of data allow organisations to develop and implement impactful and evidence-based strategies. GALVmed’s Commercial Development and Impact Function is committed to a developmental approach to monitoring, evaluation, and learning (MEL), which means that we use rapid learning to improve a project programme or affirm the need for a change of course.

To be truly developmental, this learning needs to feed back in a systematic way into our organisation. How do we do that? We use a framework for lessons learning to ensure that the lessons are integrated back into GALVmed. The Collaboration, Learning and Adapting (CLA) framework, developed and used by USAID, is a useful approach that we have adapted to frame our learning process. USAID defines CLA as “a set of processes and activities that help ensure programming is coordinated, grounded in evidence, and adjusted as necessary to remain effective throughout implementation” (ADS 201, 2016).

CLA is based in the understanding that development projects operate in complex systems, which shift over time. In this changing landscape, the objectives that we set out at the beginning of a project or programme can be affected over a three or five year period of performance. Responding in an adaptive manner ensures that we keep moving towards having a positive impact. The adaptive decisions we make must be based in evidence, which is why we are integrating processes for CLA into the beginning of our projects or programmes and adjusting these throughout the project or programme life cycle. Essentially, this is an approach to learning that fits in perfectly with our developmental approach.

There are three main steps in our learning process:

  1. The first step is to accurately define and diagnose the problem (or best practice). Some problems are logistical or operational and have easy fixes. But these, while important, do not usually make or break a project. Others are deeper and more complex and require a lot more thought and reflection to unpack them and to understand how to respond to them. Sometimes there are multiple causes to a problem, with some of them being root causes.
  2. The second step is to categorise the problem (or best practice). The use of categories ensures key information is not missed and helps to focus our thinking on lessons. To ensure consistency across projects, there are standard categories for each project and additional categories specific to a project can be added as needed.
  3. The third step is to define a road map for the way forward. This involves defining what action needs to take place, and how to know when that action has succeeded. At the end of a lessons learning exercise, there should be a road map that takes us from a lesson to action and adaptation.

Throughout this process, active collaboration is key to ensuring that we view our lessons from multiple perspectives and that our stakeholders have a voice.

This blog was written by Katharine Tjasink

The YouTube pig farmer

Pig production in India has increased substantially in recent times. It is considered one of the most sustainable industries in the country. Pigs as compared to other livestock species have great potential to contribute to faster economic return to the farmers, because of certain inherent traits like high fecundity, better-feed conversion efficiency, early maturity and short generation interval. Pig farming also requires small investment on buildings and equipment.

An estimated half a million people in India are involved in pig farming and 70% of the pig population is reared under traditional smallholder, low-input demand driven production

Mahendra Singh, 46, is one such small-scale farmer. Hailing from the village of Chirlamujapata near Prayagraj city of Uttar Pradesh province, he had ambitions of going beyond his family’s traditional farming activities and ventured into pig farming. He got inspiration from watching YouTube videos on pig farming, and in 2019 he, along with his brother Rahul Singh set up a pig farm, armed with the knowledge from YouTube and consultations from a few farmers in his locality who reared pigs.

They started small but have been able to grow the business gradually even in the hard times of the pandemic.

“We spend about INR 18 lakh (approximately US $23,800) every year and make a profit of INR 15 lakh (approximately US $19,800) annually. Of the sales we make, about 40% is profit,” says Mahendra. The expenditures include buying piglets, feed, medicines & healthcare, labour, electricity etc.

To ensure that the pigs are healthy, Mahendra has been working with representatives of Hester Biosciences, who regularly visit farmers within the locality to support them with their animal health needs. Hester Biosciences has been working with GALVmed and local government officials in provision of crucial veterinary medicines and advice targeted at small-scale livestock producers.

Animal healthcare worker attends to Mahendra’s pigs


After the initial intensive guidance, Mahendra is now able to proactively make decisions regarding the health of the pigs. “In the three years I have been in business, I am happy with the success we have been able to achieve.”
But this success has not been without hard work and growing pains. After the initial capital of INR 9 lakh (approximately US $11,880) more expenses cropped up that required more capital injection to the tune of INR 26 lakh (approximately US $34,320). The business was finally able to break even after two years, which is a feat, considering disruptions caused by the pandemic.

Apart from the regular feed given to the pigs, Mahendra used mineral supplements such as Repro Plus and for pregnant sows, Protin C. The supplement is given to the sows even after the deliveries of piglets.

The farm can have up to 300 animals at a time. Pigs are sold once every six months and most of them are transported to the north-eastern states of the country, where pig consumption is high. The business has become the main source of income for Mahendra and his family. He has set an example of success that may soon be emulated by others.

As success spread, so did interest, and more small-scale producers continue to venture into pig farming. In Mahendra’s locality, about 60 farmers are involved in pig farming now. And these farmers will require animal health services and information to take care of their pigs and improve their livelihoods.

With the profit from the business, Mahendra and his brother have invested in a proper pigsty

Improved healthcare increases milk yields for small-scale dairy producers

Small-scale dairy production in developing countries is subject to many risks from diseases. In India, GALVmed is working with Hester Biosciences to improve the knowledge of small-scale dairy producers in disease prevention, management and control.

More information about this project: http://ow.ly/1oub50JgiC6