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.

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