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 [email protected]