The East African Community Medicines Regulatory Harmonization (EAC-MRH) Programme was launched in 2012 with a charitable purpose of improving access to safe, efficacious and good quality essential medicines for the treatment of conditions of public health importance in the East African Community Partner States. The overall goal of this programme is to have a harmonized and functioning medicines registration and regulation system within the East African Community in accordance with the national and internationally recognized standards and best practices. The EAC-MRH Programme is collaboratively being implemented by all the six (6) National Medicines Regulatory Authorities (NMRAs) in the EAC region namely; Department of Pharmacy, Medicines and Laboratories (DPML) of Burundi, National Drug Authority (NDA) of Uganda, Pharmacy and Poisons Board (PPB) of Kenya, Pharmacy Task Force (PTF) of Rwanda, Tanzania Food and Drugs Authority (TFDA) and Zanzibar Food and Drugs Agency (ZFDA). At regional level, the East African Community Secretariat coordinates implementation the EAC-MRH Programme in accordance with the approved objectives and timelines. The Secretariat in collaboration with other development partners also coordinates mobilization of resources to run the Programme.

EAC Council of Ministers (Approving Organ) EAC Sectoral Council of Ministers of Health 8 EAC Sectoral Committee on Health Project Steering Committee Forum of Heads of NMRAs (Established to fast track decisions) EAC Secretariat Coordination Programme Regional and National staff Team Expert Working Groups (EWGs) EWG on Medicines Evaluation and Registration (MER) – Lead country; Tanzania Initially

EWG on Good Manufacturing Practice (GMP) – Lead Country; Uganda
EWG on Quality Management System (QMS) – Lead country; Kenya
EWG on Information Management System (IMS) – Lead Country; Rwanda
Now EWG on Pharmaceutical Policy, Legal and Regulatory Frameworks – Lead country; Tanzania
Added EWG on Medical Devices and Diagnostics– Lead country; Tanzania
EWG on Pharmacovigilance and Post Marketing Surveillance – Lead country; Kenya

ANALYSIS OF SAMPLES

The EAC harmonized guidelines, requirements and standards for Medicines Evaluation and Registration (MER), Good Manufacturing Practices (GMP) and Quality Management Systems (QMS) were approved by the 29th Ordinary meeting of the EAC Council of Ministers on 20th September 2014 through its Decision EAC/CM29/Decision 036. The Decision directed the EAC Partner States’ National Medicines Regulatory Authorities (NMRAs) to begin domesticating and implementing the approved EAC harmonized guidelines, requirements and standards for MER, GMP and QMS from 1st January 2015.

ON JUNE 2015, ZANZIBAR FOOD AND DRUGS BOARD (ZFDB) ADOPTED THE EAC HARMONIZED GUIDELINES OF GMP, MER AND QMS.

The EAC harmonized guidelines contain the common technical document as well as the common criteria to be used for evaluation and registration of medicinal product dossiers. Applicants wishing to apply for marketing authorization of their medicinal products in the region may refer to the First Invitation of Expression of Interest and the Notice to Applicant – EAC Procedure for Marketing Authorization of Medicinal Products Dossiers contained in the Press Release issued by the EAC Secretariat on 14th January 2015. The adopted EAC harmonized guidelines on MER and GMP are accessible online on the websites of EAC Secretariat and all EAC NMRAs listed below.
www.eac.int
www.mrh.eac.int
www.zfda.go.tz
www.pharmacyboardkenya.org
www.nda.or.ug
www.tfda.or.tz

Phase II of the EAC MRH Programme started on 1st January 2015. During this Phase, the main focus will be joint assessments and joint GMP inspections for marketing authorization of medicines, improvement of regulatory services by the NMRAs through implementation of harmonized Quality Management System (QMS) and Information Management System (IMS) and advocacy and communication of the EAC-MRH Programme.

SUMMARIZED STEPS ON EAC PROCEDURE FOR MARKETING AUTHORIZATION OF MEDICINES

Submission
Submit soft copies of the product dossier(s) with the required information to the lead country in Medicines Evaluation and Registration (MER) which is Zanzibar Food and Drugs Board. If the dossier is complete upon screening, submit the product dossier(s) to the remaining five EAC National Medicines Regulatory Authorities (NMRAs). Fees to be paid by the applicants to all EAC NMRAs shall continue to follow national Fees Regulations.

Evaluation
First evaluation will be done within one month from the date of acceptance of the application and second evaluation will be done within one week after the first evaluation. Incase additional data is required and response is submitted, evaluation will be done immediately after receipt of response.

Registration
Once satisfied with the evaluation and GMP inspection, a notification letter will be issued by the EAC Secretariat to the applicant/manufacturer. National approval will be granted within three months from the date of joint acceptance as agreed by all EAC Partner States’ NMRAs. The letter which confirms the final registration outcome will be communicated by the respective NMRAs.

Maintenance
Registered products shall be maintained in each NMRA’s list of registered products subject to continued compliance with registration requirements, National Health Policies

DOCUMENTS DOWNLOADS

GOOD MANUFACTURING PRACTICES (GMP)

GOOD MANUFACTURING PRACTICES TECHNICAL DOCUMENTS

MEDICINES EVALUATION AND REGISTRATION