esubmissions - topra · swissmedic • swiss agency for therapeutic products • hallerstrasse 7...

Swissmedic • Swiss Agency for Therapeutic Products • Hallerstrasse 7 • CH-3000 Bern • www.swissmedic.ch

eSubmissions

Janine Weix

Scientific Collaborator

Department Submissions

Swissmedic

2013/09/26

2

Overview

• Submissions – Our Tasks

• The future is digital

• IT Roadmap

Prime

DMS

eGov

• eCTD

• eDok

Swissmedic

3

Submissions – Our Tasks

4

System support

Automation of work processes

Harmonisation and standardisation of the activities

Process improvements, batch handling, economies of scale

Grouping tasks together within a separate organisational unit

Creating the basis for the next steps

Submissions – Our Tasks

5

6

Overview



• IT Roadmap

Prime

DMS

eGov

• eCTD

• eDok

The future is digital! Aim: In the future Swissmedic wants to digitalise all internal processes

Pro

ce

ss

ing

Business processes

with digital

• Business case data

• Technical data

• Documentation

Incoming Outgoing

Case Manager

Reviewer

Referee

8

The future is digital!

+ Digital

Data Management

• Business case

data

• Administrative data

• Technical data

• Documentation

eCTD

eForms /

Web-Portal

eCTD

eDok

Scanning

9

Overview



• IT Roadmap

Prime

DMS

eGov

• eCTD

• eDok

Programm Jahr

Quartal

2012 2013 2014 2015 2016 2017 ….

1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4

Qu

ers

ch

nit

tan

wen

du

ng

en

Sw

issm

ed

ic

Betriebswirtschaftliche Anwendung

Geschäftsfallverwaltung / Fachdach

/ Planung

Dokumentenbewirtschaftung

eGovernment

Business Intelligence

Langzeitarchivierung

Fach

sp

ezif

isch

e

An

wen

du

ng

en

Marktüberwachung

Bewilligungen

Zulassungen

Infr

a-

tru

ktu

r Erneuerung Büroautomation

IT Roadmap 2012 – 2016

ERP Neue

Releases

Frozenzone

für System-

Updates

Studie CMS

NDS-WEB

MESA-DB

ISCS

TAM

Stand: Oktober 2012

Office

AIPS

Initialisierung 10

PRIME

DLS

FPE-I FPE-II FPE-III

Vigilanz Ausbau 1

AIPS Studie

W7+

SAP HCM

CRM/ERP Ausbau 3

DMS Ausbau 2

eGov Ausbau 2

Collaboration

Langzeitarchiv

MIS

Webauftritt

eGov Portal

Hämovigilanz MUVP Studie

DMS

Geplante Vorhaben Laufende Vorhaben

Als Projektende sind die jeweiligen

Einführungstermine (Go Live)

abgebildet.

Die Abschlussphasen sind zur

besseren Übersichtlichkeit nicht

dargestellt.

El. Signatur

SIMES 4

DMS Ausbau 1

eCTD Validierung

BAB

FI/PI

CRM/ERP Ausbau 1 CRM/ERP Ausbau 2

eGov Ausbau 1

2-Faktor Authentisierung

Vigilanz Ausbau 2

Studie

HCM Ausbau

Change Request mit

Abhängigkeit div. Vorhaben Abgeschlossene Vorhaben

Programm Jahr

Quartal

2012 2013 2014 2015 2016 2017 ….

1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4

Qu

ers

ch

nit

tan

wen

du

ng

en

Sw

issm

ed

ic



/ Planung


eGovernment



Fach

sp

ezif

isch

e

An

wen

du

ng

en

Marktüberwachung

Bewilligungen

Zulassungen

Infr

a-

tru

ktu



ERP Neue

Releases

Frozenzone

für System-

Updates

Studie CMS

NDS-WEB

MESA-DB

ISCS

TAM

Stand: Oktober 2012

Office

AIPS

Initialisierung 11

PRIME

DLS


Vigilanz Ausbau 1

AIPS Studie

W7+

SAP HCM

CRM/ERP Ausbau 3

DMS Ausbau 2

eGov Ausbau 2

Collaboration

Langzeitarchiv

MIS

Webauftritt

eGov Portal


DMS




abgebildet.



dargestellt.

El. Signatur

SIMES 4

DMS Ausbau 1

eCTD Validierung

BAB

FI/PI


eGov Ausbau 1


Vigilanz Ausbau 2

Studie

HCM Ausbau

Change Request mit


Objectives:

Enhanced efficiency through: 100% paperless business processing within Swissmedic

and elimination of physical dossiers

Fewer media transitions (electronic – paper - electronic)

Automation of partial steps using IT

(intelligent forms, portal, data gateway, technical

validation)

Accelerated interaction (Traditional mail -> Portal)

Programm Jahr

Quartal

2012 2013 2014 2015 2016 2017 ….

1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4

Qu

ers

ch

nit

tan

wen

du

ng

en

Sw

issm

ed

ic



/ Planung


eGovernment



Fach

sp

ezif

isch

e

An

wen

du

ng

en

Marktüberwachung

Bewilligungen

Zulassungen

Infr

a-

tru

ktu



ERP Neue

Releases

Frozenzone

für System-

Updates

Studie CMS

NDS-WEB

MESA-DB

ISCS

TAM

Stand: Oktober 2012

Office

AIPS

Initialisierung 12

PRIME

DLS


Vigilanz Ausbau 1

AIPS Studie

W7+

SAP HCM

CRM/ERP Ausbau 3

DMS Ausbau 2

eGov Ausbau 2

Collaboration

Langzeitarchiv

MIS

Webauftritt

eGov Portal


DMS




abgebildet.



dargestellt.

El. Signatur

SIMES 4

DMS Ausbau 1

eCTD Validierung

BAB

FI/PI


eGov Ausbau 1


Vigilanz Ausbau 2

Studie

HCM Ausbau

Change Request mit


Prime - New business case management system

- Provision of the core systems for the new IT architecture

- New structure for the technical database

- Discontinuation of the existing JDE platform

- Gradual implementation: First, Submissions and Licensing, then

other sectors with Authorisation as the main focus

- Extension to other technical processes and areas, rollout of other

functions

- System integration towards eGov and DMS

Programm Jahr

Quartal

2012 2013 2014 2015 2016 2017 ….

1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4

Qu

ers

ch

nit

tan

wen

du

ng

en

Sw

issm

ed

ic



/ Planung


eGovernment



Fach

sp

ezif

isch

e

An

wen

du

ng

en

Marktüberwachung

Bewilligungen

Zulassungen

Infr

a-

tru

ktu



ERP Neue

Releases

Frozenzone

für System-

Updates

Studie CMS

NDS-WEB

MESA-DB

ISCS

TAM

Stand: Oktober 2012

Office

AIPS

Initialisierung 13

PRIME

DLS


Vigilanz Ausbau 1

AIPS Studie

W7+

SAP HCM

CRM/ERP Ausbau 3

DMS Ausbau 2

eGov Ausbau 2

Collaboration

Langzeitarchiv

MIS

Webauftritt

eGov Portal


DMS




abgebildet.



dargestellt.

El. Signatur

SIMES 4

DMS Ausbau 1

eCTD Validierung

BAB

FI/PI


eGov Ausbau 1


Vigilanz Ausbau 2

Studie

HCM Ausbau

Change Request mit


DMS

- The internal transition to a mainly paperless approach to

processes and tasks – which has already started – will continue

- New functions for secure, clear and guided document

management

- Paper documentation digitised and made available electronically

- Solution components: Microsoft Sharepoint

- Three-step implementation:

- Basic DMS functions (scanning, creating first processes)

- Expansion steps 1 and 2: application to additional

processes

Programm Jahr

Quartal

2012 2013 2014 2015 2016 2017 ….

1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4

Qu

ers

ch

nit

tan

wen

du

ng

en

Sw

issm

ed

ic



/ Planung


eGovernment



Fach

sp

ezif

isch

e

An

wen

du

ng

en

Marktüberwachung

Bewilligungen

Zulassungen

Infr

a-

tru

ktu



ERP Neue

Releases

Frozenzone

für System-

Updates

Studie CMS

NDS-WEB

MESA-DB

ISCS

TAM

Stand: Oktober 2012

Office

AIPS

Initialisierung 14

PRIME

DLS


Vigilanz Ausbau 1

AIPS Studie

W7+

SAP HCM

CRM/ERP Ausbau 3

DMS Ausbau 2

eGov Ausbau 2

Collaboration

Langzeitarchiv

MIS

Webauftritt

eGov Portal


DMS




abgebildet.



dargestellt.

El. Signatur

SIMES 4

DMS Ausbau 1

eCTD Validierung

BAB

FI/PI


eGov Ausbau 1


Vigilanz Ausbau 2

Studie

HCM Ausbau

Change Request mit


eGov Portal - Basic introduction of a Swissmedic portal with integrated identity

management

- Objective: Creation of a basic structure and provision of the first portal-based

government service for the stakeholders

- Prerequisite for integration / opening of new eGov services

- Basis for operating all eGov services via central identity management

- Basic introduction:

- Evaluation of an external partner to create the portal

- Building up a basic operational infrastructure

- Provision of basic services (central identity management)

- First key areas of use:

- Track & trace for applications

- Secure mail for information exchange

- Mass upload for eSubmissions

15

Overview



• IT Roadmap

Prime

DMS

eGov

• eCTD

• eDok

eCTD

eCTD proportion of new NASs (new active substances): ~ 80%

eCTD proportion of applications for first time authorisations: ~ 30%

eCTD proportion of all eCTD-enabled applications: ~ 6%

Proportion of firms that submit applications in eCTD format: ~ 19%

16

eCTD: New validation criteria

Swiss validation criteria (A,B,C Errors) adapted to the EU validation criteria

version 4.1 (Pass/Fail and Best Practice Criteria)

Close alignment to the EU, i.e. less Swiss specific criteria

Module 1 specification updated (new nodes)

Update of the Swissmedic review tool EiY, the validators, as well as the

publishing tools of the industry

Adjustment of the other guidance documents: „Guidance for Industry“ and

„Q&A“

Implementation published on 01 July 2013 (six-month transition period until 31

Dec 2013)

17

eCTD: New validation criteria

Swiss validation criteria (A,B,C Errors) adapted to the EU validation criteria

version 4.1 (Pass/Fail and Best Practice Criteria)

Close alignment to the EU, i.e. less Swiss specific criteria

Module 1 specification updated (new nodes)

Update of the Swissmedic review tool EiY, the validators, as well as the

publishing tools of the industry

Adjustment of the other guidance documents: „Guidance for Industry“ and

„Q&A“

Implementation published on 01 July 2013 (six-month transition period until 31

Dec 2013)

18

Advantage for Applicants:

Only minor adjustments of EU submissions required

Advantage for Swissmedic:

Higher percentage of correct submissions „at first go“

19

Overview



• IT Roadmap

Prime

DMS

eGov

• eCTD

• eDok

20

Paper

eCTD

eDok

Original Copy

eDok

Digital data Signed

documents

Guidelines – general

21

Basic principle

“Once eDok, always eDok” (as for

eCTD) is not planned.

A change between paper and eDok

will be possible at all times.

Confirmation by the company

The company confirms the identity of

the electronic copy and the paper

application, and authorises that the

review can be carried out on the

electronic documents alone.

Scope

eDok is accepted for authorisation

applications for human and veterinary

medicines (CTD and NTA).

It can be used for synthetics as well as

complementary and herbal medicines.

The format will not be available for

medicinal products submitted by

HOMANT.

Currently excluded application types :

Variations requiring notification

Variations requiring approval without

scientific assessment

Guidelines – content

22

TOC

References by means of TOC and / or

stating module / page nos., etc.

References must be designed in such

a way that they can be found in the

eDok, e.g. see Module 3.2.P.6,

document name, page 25

Hyperlinks

Hyperlinks within the documents are

recommended but not compulsory

Bookmarks

Bookmarks within the documents are

recommended but not compulsory

Guidelines – data

23

Fixed / variable file names

File names have both fixed and

variable parts.

Fixed parts may be predefined by

Swissmedic, e.g. YYYYMMDD.

The rest can be defined by the

company.

Maximum path length

180 characters

File size

max. 100MB per PDF

Guidelines – directory structure

24

Fixed / variable naming

The directories in the templates have

fixed names that must not be

changed.

The naming of the directory for trials is

variable but should nevertheless follow

certain guidelines.

Templates with predefined structure

Are the parts of the directory

structure in CTD and NTA format that

cannot be changed

Are provided by Swissmedic.

Parts to be submitted

- Only folders containing data should

be submitted.

CTD – module 1

m1

10-coverletter

12-forms

121-foapplvar

1221-fofulldecl

1222-fomanufacturer

1223-fovarnotif

1224-fovarauthor

1225-fostatusma

1226-forenewal

1227-fohumanblood

1228-foanimalhuman

1229-fopharminfo

12210-focomarketing

12211-foparagraph14

12213-fochangemah

12214-clcontentval

12215-clparagraph13

12216-fopsur

12217-foradio

12218-fogmo

12219-fodmf

12220-foparagraph13

12221-fodist

12222-forecogorphan

12223-recogfasttrack

12224-foother

12299-fonosample

123-doc-prod-quality

124-manuf

13-product-info-and-pack-mat Fi/PI

Packmaterial

14-Information-about-the-experts

15-data-of-bioavail-stud

16-ERA

17-doc-foreign-authorities

18-Pharmacovigilance

110-PIP

111-add-info

Responses-to-Swissmedic-LoQ

working-documents

25

CTD - module 4

m4

41-TOC

42-Study-Reports

421-pharmacol

4211-prim-pd Ein Ordner Pro Studie

4212-sec-pd Ein Ordner Pro Studie

4213-safety-pharmacol Ein Ordner Pro Studie

4214-pd-drug-interact Ein Ordner Pro Studie

422-pk

4221-analyt-met-val Ein Ordner Pro Studie

4222-absorp Ein Ordner Pro Studie

4223-distrib Ein Ordner Pro Studie

4224-metab Ein Ordner Pro Studie

4225-excr Ein Ordner Pro Studie

4226-pk-drug-interact Ein Ordner Pro Studie

4227-other-pk-stud Ein Ordner Pro Studie

423-tox

4231-single-dose-tox Ein Ordner Pro Studie

4232-repeat-dose-tox Ein Ordner Pro Studie

4233-genotox Ein Ordner Pro Studie

4234-carcigen Ein Ordner Pro Studie

4235-repro-dev-tox Ein Ordner Pro Studie

4236-loc-tol Ein Ordner Pro Studie

4237-other-tox-stud Ein Ordner Pro Studie

43-lit-ref

26

Thank you!

27

esubmissions - topra · swissmedic • swiss agency for therapeutic products • hallerstrasse 7...

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