Development of CTD for registration of
medicines for EAC Medicines Regulatory
Harmonization Programme
…………………Country National Stakeholders
Consultation Meeting dd/mm/yy
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Background
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Composition of the TWG-MER
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Responsibility
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Progress
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Challenges
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Way forward
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Conclusion
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Chapter 21 (Article 118) of the EAC Treaty
◦ Provides for harmonization of drug registration and
regulation
 Harmonize drug registration procedures
 Harmonize national health policies and
regulation and promote the exchange of
information on health issues in order to
achieve quality health within the Community.
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Purpose: To harmonize medicines registration in the
EAC Partner States in order to
◦ increase the rapid availability of safe, efficacious and
good quality essential medicines in the region
◦ enable free movement of pharmaceuticals within the
region to complement the implementation of the EAC
Customs Union operational since 2010
Goal: To have a harmonized and functioning medicines
registration system within the East Africa Community in
accordance with national and
internationally
recognized policies and standards i.e. WHO & ICH]
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Constituted by 12 members drawn from all the 6 EAC
Partner States’ NMRAs. i.e.
Kenya Pharmacy and Poison Board (future KFDA)
National Drug Authority of Uganda
Tanzania Food and Drugs Authority (TFDA) – Lead
country
Zanzibar Food and Drug Board (ZFDB)
Rwanda Pharmacy Task Force (future RFMA)
Department de la Pharmacie, du Médicament et des
Laboratoires (DPML) of Burundi (Future ABREMA)
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To develop harmonized technical
requirements and guidelines for registration
of human medicines.
Develop EAC Common Technical Document
(CTD) format for application for registration
of human medicines in EAC.
Present the developed CTD, technical
requirements and guidance for application for
registration of medicines in EAC to the
Steering Committee for approval.
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Develop assessment guidelines and Standard
Operating Procedures (SOPs) for assessment of
medicines dossiers.
Identify and develop a list of vital essential and
necessary (VEN) medicines that will be jointly
assessed by EAC Partner States and present to the
project Steering Committee for approval.
Facilitate domestication of the agreed technical
document for registration of medicines, guidelines
and SOPs for application and assessment of
dossiers.
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Meetings held
• 23 Video conferences - between July 2012 and August
2013
• 3 face to face meetings- in July, October 2012 and May
2013
• Drafting and Development of EAC – guidelines/documents
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1.
EAC Guidelines on Submission of
Application for registration of Medicines
Common Technical Document (CTD) with
appendixes – mother document
 Provide guidance for applicants preparing a
Common Technical Document for registration of
medicines
 Describes how to organise applications based on
the International Conference on Harmonisation of
Technical Requirements
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The CTD consists of 5 modules:
• Module 1: Prescribes Administrative
Information and Prescribing Information
requirements,
• Module 2: Quality overall summary (QOS),
• Module 3: Quality (API and FPP),
• Module 4: Non-clinical,
• Module 5: Clinical
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•
Annexes
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Annex I – Covering letter.
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Annex II – EAC application form
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Annex III – Expert report.
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Annex IV – Letter of access for DMF/CEP.
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Annex V – Quality Overall Summary
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Annex VI – Quality review requirements.
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2.
Quality overall summary of module 2
and module 3: quality
 Assist
applicants on the preparation of the
Quality Module for generic medicinal products
 Provides
clear general guidance on the format of
presenting information
 Provide
guidance on the technical and other
general data requirements.
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Quality overall summary (QOS)
 Overview
of Module 3
 Emphasize
critical key parameters of the product
 Key
issues that integrates information from
sections in the Quality Module and supporting
information from other Modules (e.g.
qualification of impurities via toxicological
studies).
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Module 3:
Main data on quality of API and FPP
 API
data submission
Options 1: EAC-Active pharmaceutical ingredient
master file (EAC-APIMF) or
Option 2: Full details in the Marketing Application
Dossier (MAD).
 FPP
– full documentation
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3 . Requirements for stability studies
Active pharmaceutical ingredient
 Finished pharmaceutical ingredient
 Address new and existing APIs/FPP
 Not applicable for biologicals – vaccines
 Stress stability
 Regulatory stability – accelerated and long term
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Long-term
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30 °C ± 2 °C/75% RH ± 5% RH
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Accelerated
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40 °C ± 2 °C/75% RH ± 5% RH 6 months
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 Storage
conditions requirements for FMPs
intended for storage in a refrigerator
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Long-term
5 °C ± 3 °C 12 months
Accelerated
25 °C ± 2 °C/60% RH ± 5% RH or
• 30 °C ± 2 °C/65% RH ± 5% RH or
• 30 °C ± 2 °C/75% RH ± 5% RH
 FMPs intended for storage in a freezer
• 5 °C± 3 °C or 25 °C ± 2 °C or 30 °C ± 2
°C)
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 Specify
the requirements for the design, conduct,
and evaluation of bioequivalence studies
 Immediate release and modified release dosage
forms with systemic action
 Stipulates exemptions for carrying out in vivo
bioequivalence (BE)
 In vitro dissolution tests as a surrogate for in vivo
BE studies
 Other studies
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Comparative pharmacodynamics studies
Comparative clinical studies
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 Outline
procedures from submission of a dossier
to the final outcome, timeframe and procedure
for competent authorities to amend, where
necessary the conditions of marketing
authorization of a particular product.
 Provide
guidelines on general requirements –
language, font size etc
 Outline
procedures for different types of
applications; new, renewal & variation
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EAC guidelines on submission of application for
registration of human medicinal products (main
guideline).
EAC guidelines on therapeutic equivalence
requirements.
EAC guidelines on registration of fixed-dose
combinations (FDCs
EAC guidelines on biowaiver
EAC list of standard terms for pharmaceutical
dosage forms and routes of administration.
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EAC guidelines on procedural aspects of
application for registration of human
medicinal products.
EAC guidelines on stability requirements.
EAC guidelines on labeling requirements.
EAC common glossary of terms used in
medicines registration.
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10.
Annexes to the EAC guidelines on
submission of application for registration of
human medicinal products (main guideline):Annex I – Covering letter.
Annex II – EAC application form for marketing
authorization of medicinal product.
Annex III – Expert report.
Annex IV – Letter of access for DMF/CEP.
Annex V – Quality Overall Summary – Product
dossier.
Annex VI – Quality review requirements.
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To consider and approve the developed draft
documents as listed above, and which have already
been approved by the project’s regional steering
committee, for further approval processes
Also
-To continue supporting the national and regional
initiatives and efforts that are towards the
improvement of peoples lives
-To continue participating in the approval
processes that will follow at the regional level
Build more consensus and advocacy for
strengthening the existing national Medicines
Regulatory Agencies
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EAC guidelines on selection of comparator
products
EAC guidelines on application for variation of a
registered medicinal product.
EAC common assessment procedure.
Training modules on evaluation
EAC Active Pharmaceutical Ingredient (API)
procedure
Guidelines on requirements for registration of
biological/biotechnological products
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procedures for internationalization of the
approved guidelines in Partner States regulatory
systems is not yet in place
Few face to face meetings versus workload
(development of documents)
All the 6 NMRAs involved in the project activitie
are not at the same level and more funds than
budgeted will be required to build capicities in
Rwanda, Burundi and United Republic of
Tanzania (ZFDB)
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Capacity building activities planned/underway
a) Twining programme (2nd quarter - 2013/14)
b) Training on dossier assessment (3rd quarter )
c) Joint assessments (4th quarter)
d) WHO/EAC joint assessment sessions (July and
Sept 2013.....continuing)
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Appointment of TWG members for replacement
More interactive sessions – face to face meetings
at least 3 for this financial year
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