DEPARTMENT OF HEALTH

Medicines Regulatory Affairs

(Pharmaceutical & Related Product

Regulation & Management)

EDMS Workflow Specification and Software Configuration Project

Update

E Taute SAPRAA 21 Nov 2008

Slide 2

1 2 3 4

5

6

7

Software LicensesWorkflow Specifications

and Configutarion

Internal Testing

Pilot Testing

Deployment

Formal Windchill Training

(1-8)

Informal Windchill Training

(1-8)

Recruit & Train Dataprocessors

(1-8)

Document Storage(Paper)

(1-5)Document Scanning & Printing

(1-3)

Recruit Technical Experts

(1-8)

Server Network

(electronic storage)

(1-5)

Data Integration & Maintenance

(1-8)

8Help Desk & Stabilisation Support

Project ManagementScoping Workshop

Slide 3

EDMS Workflow Specification and Software Configuration Timeline

Project Phases (Deliverable) Date

Phase 1 – Assessment May 2008

Phase 2 – Design To-Be Environment July 2008

Phase 3 – Configuration November 2008

Phase 4 – Testing February 2009

Phase 5 – Implement/Operate May 2009

EDMS Workflow & Configuration Project

Slide 4

It is expected that the EDMS Project will provide the following within the scope of the configuration contract :

• Conformance to local regulatory requirements

• Ability to perform search and retrieval operations on the information stored in the system

• Ability to perform workflow management in-house

• Provide web-enabled centralised control

• Conform to international regulatory standards

• Conform to Government IT standards

• Provide necessary tools to perform publication of updated information on website

• Provide ability to maintain security/control via digital signatures

• Ability to deliver version and iteration control

• Provide a clear archiving strategy; and

• Accommodate paper-based submissions

EDMS Workflow & Configuration Project

Slide 5

• Workflow Configuration

• Document Configuration

• Scanning Capacity

• Training

• Information Management

• Data Management

• Change Management

• Human Resource Capacity Building

Current and Future Commitments

EDMS Workflow & Configuration Project

Slide 6

• International agency implementation & harmonization

• Local Industry acceptance with provisos

- security, compatibility, capacity

• Electronic process will satisfy environmental & archiving concerns

• Data integration

• Business Process Management (Standardisation and time-line control)

• Knowledge Management (Management reporting, supervision and efficiency)

• Format cross indexing (MBR1 MRF1 eCTD)

• Capacity building

EDMS Workflow & Configuration Project

Major IndicatorsMajor Indicators

Slide 8

Information Information DatabaseDatabase

& Licensing& Licensing

Evaluators (150)Evaluators (150)Evaluators (150)Evaluators (150)

MCC Chairpersons (24)MCC Chairpersons (24)MCC Chairpersons (24)MCC Chairpersons (24)

Manufacturers (300)Manufacturers (300)Manufacturers (300)Manufacturers (300)

SSEECCUURREE

FFIIRREEWWAALLLL

SSEECCUURREE

FFIIRREEWWAALLLL

Internet

WWW

InternetInternet

WWWWWW

Secure InformationSecure InformationAdaptersAdapters

PVPVMedunsaMedunsa

General PublicGeneral PublicGeneral PublicGeneral Public

PharmacistsPharmacists

MedicalMedicalDoctorsDoctors

Other HealthcareOther HealthcareProvidersProviders

EDMS

LaboratoryLaboratoryBloemfonteinBloemfontein

Software Software VendorsVendors

ADRADRCape TownCape Town

ExternalExternalNRA AgenciesNRA Agencies

SiamedZizoCam

Clinical Trials & PV

CIS

CO

netw

ork &

Ca

blin

g

192Kb Diginet Line

& ISDN Backup

High Security & Climate Control

& backup power

Registry

Gr Fl (3)

Registry

Gr Fl (3)

Cluster Mgmt

2nd Fl (5)

Cluster Mgmt

2nd Fl (5)

Ops & Admin

2nd Fl (7)

Ops & Admin

2nd Fl (7)

MER

11th Fl (6)

MER

11th Fl (6)

CT & E

12th Fl (8)

CT & E

12th Fl (8)

I & LE

13th Fl (8)

I & LE

13th Fl (8)

Enquiries

2nd Fl (1)

Enquiries

2nd Fl (1)

Scanning

2nd Fl (1)

Scanning

2nd Fl (1)

Security Control & Encryption

Video Conferencing

3 x ISDN

Video Conferencing

3 x ISDN

PVPVBloemfonteinBloemfontein

LaboratoryLaboratoryPotchefstroomPotchefstroom

MCC Board

12th Fl (1)

MCC Board

12th Fl (1)

MRA Network Topology

Slide 9

Delays and Problems• EU Funding

• Delay in award of contract and eventual sign-off

• Software funded by DoH

• Specialists for testing (implementation support) – Appointment not approved

• Data capturers not yet optimally utilised

• Server security

• Amendment Bill

EDMS Workflow & Configuration Project

Successes and Milestones• Windchill in Licensing up and running

• Hardware Audit Completed

• As-Is Process Maps completed

• To-be Process Maps completed

• Commenced with configuration

EDMS Workflow & Configuration Project

Why?

Harmonisation

To provide for a common format/template for the submission of information to the regulatory authorities in the 3 ICH regions + South Africa

• “Common Technical Document” signed-off by ICH in November 2000

Advantages / Objectives:• Resource saving for industry• Facilitate simultaneous submission in all the regions• Facilitate exchange of regulatory information• Harmonised format to be further supported by the eCTD• More efficient assessment, e.g. use of hyperlinks• Faster availability of new medicines

CTD / eCTDCTD / eCTD

EDMS Workflow & Configuration Project

However, CTD is only a FORMAT !

It’s not a “single” dossier, with a “single” content since

• Legal requirements differ in the regions

• ICH guidelines have not yet harmonised all requirements

• SA guidelines not all harmonised

• Pharmacopoeiae are not harmonised

CTD / eCTDCTD / eCTD

QualityOverall

Summary2.3

Non-clinicalOverview

2.4

ClinicalOverview

2.5

Non-clinicalSummaries

2.6

ClinicalSummary

2.7

Module 3

Quality3.0

Module 4Non-clinical

Study Reports4.0

Module 5Clinical

Study Reports5.0

Module 2

CTD Table of Contents2.1

CTD Introduction2.2

Module 1Regional

Information1.0

Module 2-5 CTD

Module 1:Not Part of the CTD Content to be determined by authorities

12

Module 2

EDMS Workflow & Configuration Project

Module 2Module 2

Modules 3 - 5

Modules 3 - 5

Heart of Dossier

MRF1

PART 2 Basis for Registration and Overview of Application

PART 2A Pharmaceutical and biological availabilityPART 2B SBRA

PART 2C Pharmaceutical Expert Report

PART2D Pre-Clinical Expert Report

PART 2E Clinical Expert Report

CTD

Module 2

Section 2.3 Quality Overall Summary

Section 2.4 Nonclincial Overview

Section 2.6 Nonclinical Written and Tabulated Summaries

Section 2.5 Clinical Overview

Section 2.7 Clinical Summary

Technical “part” of Dossier

MRF1PART 3 Pharmaceutical & Analytical

PART 3A: Active Pharmaceutical Ingredient (API)

PART 3B: Formulation

PART 3C: Specifications & Control Procedures for Pharmaceutical Ingredients

PART 3D: Container & Packaging Materials

PART 3E: Manufacturing Procedure

PART 3F: Final product Specifications & Control

PART 3G: Stability Data of the Finished Pharmaceutical Product (FPP)

PART 3H: Pharmaceutical Development

PART 3I: Expertise and premises used for the Manufacture of a Biological Medicine

CTDModule 3

3.2.S Drug substance

3.2.P Drug Product

3.2.P.1 Description and composition of the drug

3.2.S.4 Control of Drug Substance

3.2.P.4 Control of Excipients

3.2.P.7 Container Closure System

3.2.P.3 Manufacture

3.2.P.5 Control of Drug Product

3.2.P.8 Stability

3.2.P.2 Pharmaceutical Development

MRF1

PART 3 Pharmaceutical & Analytical

PART 3A: Active Pharmaceutical Ingredient (API)

PART 3B: Formulation

PART 3C: Specifications & Control Procedures for Pharmaceutical Ingredients

PART 3D: Container & Packaging Materials

PART 3E: Manufacturing Procedure

PART 3F: Final product Specifications & Control

PART 3G: Stability Data of the Finished Pharmaceutical Product (FPP)

PART 3H: Pharmaceutical Development

PART 3I: Expertise and premises used for the Manufacture of a Biological Medicine

CTD

Module 3

3.2.S Drug substance

3.2.S.4 Control of Drug Substance

3.2.P Drug Product

3.2.P.1 Description and composition of the drug

3.2.P.2 Pharmaceutical Development

3.2.P.3 Manufacture

3.2.P.4 Control of Excipients

3.2.P.5 Control of Drug Product

3.2.P.6 Reference Standards or Materials

3.2.P.7 Container Closure System

3.2.P.8 Stability

3.3 References

Technical “part” of Dossier

• EU eCTD vs MRF1 vs SA eCTD

• Module 1 PART1

• Screening

• BE data + dissolution data

• Reference products

• Module 3 “Body of Data”

• On-line submission / CD / DVD

• Paper submissions

• Paradigm shift

EDMS Workflow & Configuration Project

CTD/eCTD ChallengesCTD/eCTD Challenges