e-taotlused Triin Mäesalu Müügiloa hoidjate infopäev 26.05.2017

Sisukord

• e-taotluste tegevuskava (eSubmission Roadmap) versioon 2.0 – ülevaade

• Tsentraalse andmehoidla (Common Repository) arengud

• Euroopa ühisportaali arengud – veebipõhine „vorm“ Common European Single Submission Portal (CESSP)

• eCTD ja VNeeS formaatide tähtaegadest

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CESSP application

dataset for variations

and renewals (H & V)*

eSubmission Roadmap - timelines (reflecting final adopted version 2.0 dated 24-02-17) , EMA eSubmission

2017 2018 2019 2020

Single Submission Portal

with full integration

of eAF and SPOR*

for all submissions

(human and vet)

All submissions (human) in CP, DCP, MRP and NP in eCTD

Ongoing or optional

Mandatory

CESP (human and vet)

eGateway

(CP, human and vet)

NCA use of Common Repository for all CP submissions

(human and vet)

All submissions (vet) in CP, DCP, MRP and NP in VNeeS

All other MRP and all NP***

submissions in eCTD (human)

eAF in all procedures (human and vet)*

All submissions in CP and new MAA in DCP and MRP (human) in eCTD

Use of eCTD v.4

CP (human)**

All MRP submissions (human) in eCTD

NCA use of Common Repository for CP

submissions - human

NCA use of CR

for CP -vet

eAF variations and renewals

eGateway CESP

eAF *

CESSP *

eCTD v.4

CESSP application dataset for all new MAA (human and vet)*

*) The SPOR project will stepwise (see specific Roadmap) deliver master data services (RMS, OMS, SMS, PMS) to be

integrated with the eAF and CESSP during the roadmap period. **) Timelines subject to planning ***) National Procedures

All submissions in CP, DCP, MRP (vet) in VNeeS

All NP submissions (vet) in VNeeS

eCTD v.3.2

VNeeS

CR

One integrated

portal with Single

user registration

Planning and preparation for

the implementation of eCTD v.4

Use of eCTD v.4

MRP, DCP (human)**

All new MAA in NP (human) in eCTD

All other NP submissions in eCTD (human)

All NP submissions in eCTD (human)

All other NP submissions in VNeeS (vet)

All new MAA in NP (vet) in VNeeS

Tsentraalne andmehoidla – Common Repository (CR)

• 2014 – Tsentraalse müügiloaga (CP) inimestel

kasutatavate (HUM) ravimite eCTD formaadis taotlused • 2016 – Lisandusid Working documents kaustad (enne

saadeti meile e-kirja teel) • 2017 II pa (täpne kuupäev selgumisel) lisanduvad:

1. etapp – HUM referral protseduurid (eCTD, NeeS, „muu formaat“) 2. etapp – tsentraalse müügiloaga VET ravimite dokumentatsioon 3. etapp – kõik EMA juhitavad protseduurid (sh WS taotlused)

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2017 2018 2019 2020

NCA use of Common Repository for all CP submissions

(human and vet)

NCA use of Common Repository for CP

submissions - human

NCA use of CR

for CP -vet

http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html

Euroopa ühisportaali arengud

• EMA portaal (eSubmission Gateway) ja CESP (Common European Submission Portal) ühendatakse

• Praegused e-taotluse vormid muudetakse veebivormiks - taotluse andmed sisestatakse CESSP (Common European Single Submission Portal) kasutajaliidese kaudu

• Lõppeesmärk - üks ühine portaal Euroopas kõikide taotluste loomiseks ja ravimiametitele esitamiseks

http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html 5

2017 2018 2019 2020

Single Submission Portal

with full integration

of eAF and SPOR*

for all submissions

(human and vet)

CESP (human and vet)

eGateway

(CP, human and vet)

eAF in all procedures (human and vet)*

eAF variations and renewals

One integrated

portal with Single

user registration

CESSP application

dataset for variations

and renewals (H & V)*

CESSP application dataset for all new MAA (human and vet)*

• Veebivorm - praeguse CESPi edasiarendus • Esimene faas - HUM/VET müügiloa taotlus Valmib 03/2018 (kohustuslik alates 09/2018)

• Teine faas – muutuse, uuendamise taotlus • eAF vorm kaotatakse pärast

üleminekuperioodi

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CESSP – Common European Single Submission Portal

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CESSP - Process flow

“application dataset”

CESSP phase 1 will use data from OMS and RMS (O and R in SPOR) in a way that organisations and referentials can be selected during the authoring process.

manual data entry /update

IT supported data upload

applicant level

integrates

CESSP Online-Tool

SPOR

creates

EMA, http://esubmission.ema.europa.eu/cessp.htm

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CESSP – Concept of the application dataset

“application dataset” (= eAF and even MORE) contains information used in the application form and can also be reused for other purposes

Human readable application data

CESP delivery file

Electronic data format for automated data import

Draft cover letter, Draft EMA formatted table template

EMA, http://esubmission.ema.europa.eu/cessp.htm

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Future process after implementation of CESSP Phase 1

Import file for IT systems

Draft Cover Letter,

Dossier

Finalise dossier submission

CESP

EMA Gateway

Submit Process

submission

EMA/ NCA

CESSP

Start and Finalise Application Dataset

SPOR Draft a business and technical scenario how PMS could consume and utilise application data

EMA, http://esubmission.ema.europa.eu/cessp.htm

eCTD kohustuslikuks - tähtajad

• eCTD v3.2 (praegune põhiversioon) 1.01.2018 kõik MRP taotlused (ka ASMF, PSUR jne) 1.07.2018 riiklikud esmase müügiloa taotlused 1.01.2019 kõik taotlused (ka ASMF, PSUR jne)

• Eelmiselt formaadilt üleminekul soovitus (aga mitte kohustus) esitada eCTD baseline 0000

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All submissions (human) in CP, DCP, MRP and NP in eCTD All other MRP and all NP***

submissions in eCTD (human)

All submissions in CP and new MAA in DCP and MRP (human) in eCTD

All MRP submissions (human) in eCTD

All new MAA in NP (human) in eCTD

All other NP submissions in eCTD (human)

All NP submissions in eCTD (human)

2017 2018 2019 2020

http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html

VNeeS kohustuslikuks - tähtajad

1.01.2017 – kõik CP, DCP, MRP taotlused (ka ASMF, PSUR jne)

1.07.2018 – riiklikud esmase müügiloa taotlused 1.01.2019 – kõik taotlused (ka ASMF, PSUR jne)

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All submissions (vet) in CP, DCP, MRP and NP in VNeeS

All submissions in CP, DCP, MRP (vet) in VNeeS

All NP submissions (vet) in VNeeS All other NP

submissions in VNeeS (vet)

All new MAA in NP (vet) in VNeeS

2017 2018 2019 2020

http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html

Aitäh! Triin Mäesalu triin.maesalu@ravimiamet.ee