Hamornization and International Collaboration
East African Community Medicines Regulatory (EAC – MRH) Programme
What is EAC – MRH?
The East African Community Medicines Regulatory (EAC – MRH) Programme was launched in 2012 becoming the first Regional Economic Community (REC) in Africa to initiate harmonization procedures for medicines regulation under the African Medicines Registration Harmonization Initiative (AMRHI). The Programme aimed at establishing harmonized and functioning medicines registration and regulation systems within the East African Community (EAC) in accordance to the national and internationally recognized standards and best practices. Implementation of the Programme is done by the National Medicines Regulatory Authorities (NMRAs) in all EAC Partner States namely: The Department of Pharmacy, Medicines and Laboratories (DPML) of Burundi, The National Drug Authority (NDA) of Uganda, Pharmacy and Poisons Board (PPB) of Kenya, Pharmacy Task Force (PTF) of Rwanda, Drug and Food Control Authority (DFCA) of South Sudan as well as The Tanzania Food and Drugs Authority (TFDA) and The Zanzibar Food and Drugs Agency (ZFDA) of the United Republic of Tanzania. Objectives
- To implement an agreed upon common technical document for registration of Medicines in the EAC Partner States
- To implement a common information management system for medicines registration in each of the EAC Partner States’ NMRAs which are linked in all Partner States and EAC Secretariat
- To implement a quality management system in each of the EAC Partner States’ NMRAs
- To build regional and national capacity to implement medicines registration harmonization in the EAC
- To develop and implement a framework for mutual recognition based on Chapter 21, Article 118 of the East African Community Treaty.
- To create a platform for information sharing on the harmonized medicines registration system to key stakeholders at national and regional level
Progress made under EAC – MRH Programme
Under the EAC – MRH Programme the following deliverables have been produced:
- Development of Standard Operating Procedures (SOPs) for Medicine Registration, GMP inspections and Quality Management Systems.
- Common Technical Documents (CTDs) were approved, assimilated and rolled out in all countries.
- Seven joint assessment sessions have been successfully conducted
- Several joint GMP inspections were performed.
TFDA’s role in EAC – MRH Program me
TFDA is an active participant in all EAC – MRH activities and is the twinning partner of the DPML (Burundi).
TFDA is the lead NMRA in medicines evaluation and registration under the EAC – MRH.
TFDA on behalf of other EAC NMRAs receive dossiers for joint assessment and work hand in hand with EAC Secretariat in planning the joint assessments sessions. After the applications have been jointly assessed, TFDA holds the responsibility of communicating with the Applicants until a final decision is reached for each product.
Joint Assessment Procedures
Joint assessment procedure is a formal procedure where one application is simultaneously submitted in all EAC Partner States NMRAs, so that assessment is done together such that the final results obtained are binding in all Partner States.
Joint assessment procedures are coordinated and facilitated by TFDA.
Summary of the procedure;
- Dossiers for joint assessment are received at TFDA then screened within 14 working days to ensure that all documentation is in order.
- Depending on the results of screening, the dossier will either be accepted for joint assessment or the applicant will be issued screening queries in order to address the shortcomings in their submission.
- Once the dossier is accepted for evaluation it is assigned to Partner States NMRAs for assessment. Upon completion of assessment, the report is discussed with all NMRAs.
- The applicant is then informed about the outcome of the assessment by TFDA.
Once a product is recommended for registration the applicant will be required to comply with the legal requirements for registration in each Partner State.
For more detailed requirements Applicants should refer to the EAC Guidelines on Procedural Aspects for Applications for Marketing Authorization of Pharmaceutical Products. The guidelines can be accessed through our website or at www.mrh.eac.int
Products registered under the Programme
A total of eight products have been jointly assessed and registered through EAC – MRH Programme as of December, 2017.
WHO COLLABORATIVE PROCEDURE
Collaborative Procedure for Accelerated Registration is a voluntary procedure involving WHO-prequalified medicines or medicines approved by stringent regulatory authorities where by the applicant agrees to share with TFDA the assessments reports developed during WHO – prequalification.
This was implemented in 2012 after TFDA signed a Memorandum of Understanding (MoU) with WHO for WHO - PQ Collaborative Registration Procedures were signed in 2012.
The collaborative registration procedure serves to facilitate and accelerate national registration of pharmaceutical products which the WHO Prequalification of Medicines Team (WHO/PQT) has already assessed and prequalified. WHO/PQT assessment and inspection reports are shared with participating National Medicines Regulatory Authorities (NMRAs) at the manufacturer’s request. The decision about national registration of a product is then expected to be issued within 90 days of information sharing.
Procedure for submitting applications for WHO Collaborative accelerated registration
In order to submit a prequalified FPP for registration the applicant (usually the manufacturer) should sign and email a consent form (Appendix 2) to the following email address: email@example.com This will serve to grant WHO permission to share its evaluation information with the TFDA. The signed originals of the consent form should be posted or sent by courier to: World Health Organization, L25620 Avenue Appia1211 Geneva 27Switzerland.
Advantages of the procedure
- Shortening the approval time; i.e. the products approved within 90 days from the day of submission.
- Capacity building for assessors since through access to WHO PQ assessment reports.
- Opens up communications with manufacturer which provides real time communication and resolution of the issues on time.
- Builds confidence among regulators as they work together through work sharing on assessment reports on WHO- PQ Mednet website.
Products registered under the procedure
By January 2018, a total of 21 products have been registered through the procedure. The average time for registration was 78 days