Medicinal Products Registration EMEA/FDA/SWISSMEDIC...Centralised procedure (EMEA) Presubmission...
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Medicinal Products Registration EMEA/FDA/SWISSMEDIC 5 November, 2004 Beat Schmid SWISSMEDIC Erlachstrasse 8 CH-3000 Bern
Transcript of Medicinal Products Registration EMEA/FDA/SWISSMEDIC...Centralised procedure (EMEA) Presubmission...
Medicinal Products Regist rat ion
EMEA/FDA/SWISSMEDIC
5 Novem ber, 2004
Beat Schm idSWISSMEDIC
Erlachst rasse 8CH-3000 Bern
EUJapanUSA
Regulatory World
+ Others: EFTA(CH), Canada, Aust ralia, WHO
Since 1990 = Internat ional Conference on Harm onisat ion (ICH)
Requirem ents since 1990
Regulatory World (2)
Swissm edic im plem ents all ICH Guidelinesthat have reached step 5
Internat ional Conference on Harm onisat ion (2)
Harm onisat ion of the Form at of the Dossier Com m on Technical
Docum ent (CTD)
Internat ional Conference on Harm onisat ion (3)
M odule 1
M odule 3 M odule 4 M odule 5Qualit y Nonclinical
St udyReport s
Clinica lSt udy
Report s
RegionalAdm inist rat ive
Inform at ion
NonclinicalSum m ary
Clinica lSum m ary
NonclinicalOverview
Clinica lOverviewQuali
t yOverallSum m ary
1 .1 ToC of M od 1 oroverall To, incl. M od 1
2 .3 2 .6 2 .7
2 .4 2 .5
CTD ToC (M od 2 ,3 ,4 ,5 )
CTD Int roduct ion
4 .1 ToC for
3 .1 ToC for
M od 3
2 .1
2 .2
M od 4
5 .1 ToC for
M od 5
CTDSum m ary of Product Characterist ics
Overviewsand
Sum m aries
Data
Market ing Authorisat ion Procedures
• EU (EMEA) -Market ing Authorisat ion Applicat ion (MAA)
• CH (Swissm edic) -MAA• US (FDA) -New Drug Applicat ion
(NDA)
Market ing Authorisat ion Process
Opinion
Scient if ic Assessm ent
2 nd Scient if ic Assessm ent
Dossier Validat ion
Not if icat ion of Pr im ary Decison
Not if icat ion of Decison
Market ing Authorisat ion Procedure US/FDA
The New Drug Developm ent Process:Steps from Test Tube to New Drug Application Review
http:/ /www.fda.gov/cder/handbook/
IND Review Process
http:/ /www.fda.gov/cder/handbook/
NDA Review Process
http:/ /www.fda.gov/cder/handbook/
Market ing Authorisat ion Procedure EU/EMEA
- Cent ralised Procedure- Mutual Recognit ion Procedure
Centralised Procedure (EMEA)
Medicinal Products developed by m eans of:- rDNA technology- Expression of genes coding for proteins- Hybridoma and m onoclonal ant ibody m ethods
As of 20 Novem ber 2005:
New Act ive Substances for Specified Therapeut ic Areas:- AIDS- Cancer- Neurodegenerat ive disorders- Diabetes
- Orphan m edicinal products
Centralised procedure (EMEA)Presubm ission phase
Rapport eur/co-rapport eur appoint ed
Cent ra lised procedure st art s
(Day 0 )
Rapport eur and co-rapport eur assessm ent report s circulat ed on Day
70 of procedure
Com m ent s from ot her M em ber
St at es by Day 10 0
CPM P agrees consolidat ed list of quest ions t o applicant by Day 12 0
Applicant responds within 6 m onths
JP Griffin, J O‘Grady, The Regulat ion of Medical Products, BMJ Publishing Group 2003, p.60.
Centralised procedureJoint assessm ent of responses by rapport eur and co-rapport eur w it hin 30 days (Day 1 50
of procedure)
CPM P decides w het her a hearing is required on
out st anding issues(Day 18 0 of procedure)
CPM P final opinion (Day 2 10 )
Com m ission decision aft er 9 0 days
Com m unit y aut horisat ion
JP Griffin, J O‘Grady, The Regulat ion of Medical Products, BMJ Publishing Group 2003, p.60.
Sw iss Agency for Therapeut ic Product sSince January 2 0 0 2
Market ing Authorisat ion Procedure
Responsibilit ies of Responsibilit ies of Swissm edicSwissm edic
• Swissmedic is responsible for the evaluat ion of the benefit /r isk relat ionship
- NOT Price (l‘OFAS)- NOT Reimbursem ent (l‘OFAS)
• No t reat ies with other Agencies (FDA, EMEA) about m utual recognit ion of the evaluat ion and MA:Swissmedic has to evaluate the dossier on its own
The law on Therapeut ic Products Art . 13 on m edicinal products and procedures authorized in foreign count ries states:“ If a m edicinal product or procedure is already authorized in a country having equivalent m edicinal product cont rol, the results of tests (of the other Agency) carried out for this purpose shall be taken into account .”
Many countries take into considerat ion Swissm edic Many count ries take into considerat ion Swissm edic decisionsdecisions
Responsibilit ies of Swissm edic Responsibilit ies of Swissm edic (2)(2)
Com plem ent ary andHerbal M edicines
Non-prescript ion M edicines
Non-prescript ion M edicines,M edical Devices and Est ablishm ent s
Vaccines and Blood Product s
Biot echnology M edicines
Biological M edicinesand Laborat ories
Prescript ionM edicines ATC I
Prescript ionM edicines ATC II
Vet erinary M edicines
Prescript ion M edicines, Vet erinaryM edicines and Pharm acovigilance
Divisions w it h M A process
TOXICOLOGY
Review Process
Building ofcase t eam
Individualreview
Divisionm eet ing
Peerreview
M edicines Expert
Com m it t ee m eet ing (Division
m eet ing)
Final opinionand
Decision le t t e r
RegulatoryQualityPreclinicalPreclinicalClinical
Review Tim elines
Adm inist rat ive check
Building ofcase t eam
Individual and Peer Review
M edicines Expert Com m it t ee m eet ing
Division m eet ing
2 w eeks
2 w eeks
9 w eeks
9 w eeks
5 w eeks Approval/deficiency let t er
(~ 2 00 days)
Deficiency le t t er
Appeal New M AA
Response
Reject ion
YesNo
W it hdraw al of t he M AA
Addit ional Dat a /Response t o
Deficiencies
M AA closed
30 Days
30 Days 120
Days
Negat ive opinion
Subm ission of Dossier for
„ Second loop“
anyt ime
Review
Opinion
Negat ive: Deficiency le t t er
Posit ive: Approval le t t er
200 Days
Reject ion (Reasons as
described in t he def iciency le t t e r)
W it hdraw al of t he M AA
Yes
No Adm inist rat ive check
O.K.120 Days
Appeal
30 Days
30 Days
„ Second loop“
Centralised procedure (EMEA)Presubm ission phase
Rapport eur/co-rapport eur appoint ed
Cent ra lised procedure st art s
(Day 0 )
Rapport eur and co-rapport eur assessm ent report s circulat ed on Day
7 0 of procedure
Com m ent s from ot her M em ber
St at es by Day 1 00
CPM P agrees consolidated list of quest ions t o applicant by Day 1 20
Applicant responds within 6
m onths
JP Griff in, J O‘Grady, The Regulat ion of Medical Products
Adm inist rat ive check
Building ofcase t eam
Individual and Peer Review
M edicines Expert Com m it t ee m eet ing
Division m eet ing
2 w eeks
2 w eeks
9 w eeks
9 w eeks
5 w eeks Approval/deficiency le t t er
(~ 2 00 days)
Switzerland
Centralised procedure(EMEA)Joint assessm ent of responses by rapport eur and co-rapport eur w it hin 3 0 days (Day 15 0
of procedure)
CPM P decides w het her a hearing is required on
out st anding issues(Day 18 0 of procedure)
CPM P final opinion (Day 2 10 )
Com m ission decision aft er 9 0 days
Com m unit y aut horisat ion
JP Griffin, J O‘Grady, The Regulat ion of Medical Products.
Posit ive: Approval
le t t er
M arket ing Aut horisat ion
Appeal
No Appeal
Resolut ion of m inor def iciencies (e .g.
Qualit y) ,Sm PC m odificat ions,
Condit ions
90 Days(Applicant)
90 Days(Swissm edic)
Switzerland
Average Annual Average Annual Applicat ionsApplicat ions
2 6 FDA
2 4 Sw issm edic
2 5 EM EA
Per year for New Act ive Subst ancesPer year for New Act ive Subst ancesTim e Period: 1997 – 2001Tim e Period: 1997 – 2001
USAUSA CHCH
Differences between Swissm edic Differences between Swissm edic FDAFDA
Differences Between Swissm edic Differences Between Swissm edic EMEA/FDAEMEA/FDA
• Decision based on the subm it ted dossier. No „ consolidated list of quest ions“ before prim ary opinion. No „ rolling review“
Short review t im es for applicat ions of high quality
Inconvenience for incom plete or prem ature dossiers
• Only m inor deficiencies can be dealt with during the review process
