Third Stakeholders forum on the I m plem entation of the new pharm acovigilance legislation URGENT UNION PROCEDURE (including concept of public hearings) Presented by: Anthony Humphreys London, 20 October 2011 An agency of the European Union
2 ’S TOOLKIT S TOOLKIT 0 2 e l c i t r A TODAY’ TODAY Article 3 6 SAFETY REFERRALS SAFETY REFERRALS 7 0 1 e l c 1 i t r A 3 e l c i t r A
TOMORROW’S TOOLKIT 3 0 2 e l c i t r A Article 3 6 SAFETY REFERRALS SAFETY REFERRALS ) i ( 7 0 1 e l c 1 i t r A 3 e l c i t r A
The Future: 1 0 7 ( i) NAP’s + ( MRP/ DCP’s) + CAP’s 1 / 2 MS/ EC I nitiated by when urgent action is considered necessary + criteria Tim e Lim it 60 days (PRAC) 30 days (CHMP / CG) HCP’s Consultation Public MAHs Written + / - public hearing 4
The Future: 1 0 7 ( i) NAP’s + ( MRP/ DCP’s) + CAP’s 2 / 2 PRAC recom m endation Outcom e CHMP Opinion OR CG agreem ent Com m ission Decision (CHMP - All) (CG – no agreement) + / - Tem porary m easures Final m easures Urgent Action Until definitive decision to protect may suspend marketing + public health use product 5 NO RE-EXAMI NATI ON
Article 1 0 7 ( i) I nitiation Pharm acovigilance activities – Data driven Pharm acovigilance activities + Urgency – W ho decides? Urgency Criteria : consideration of consideration of : suspension/ revocation of MA, prohibition of supply, refusal of renew al of MA; new CI , reduction in the dose, restriction to the indications. based on safety safety concerns, from MAH: interruption of the placing on the m arket, MA w ithdraw n; EC CAN initiate for NAP’s MS CAN initiate for CAP’s 6
W EB PORTAL ANNOUNCEMENT Stake Holders (not just industry) Questions + MS AR w ill be public Time limit to submit < 30 days Triage data subm itted Announcem ent intention to have a public hearing: data gathering 7
TI ME LI MI T Post PRAC data collection 3 0 days CHMP / CG 6 0 days w ritten + / - oral No clock stop No clock stop Legislation does not foresee clock stop “URGENT” UNION PROCEDURE Challenge to the assessment teams Robustness of opinion quality process 8
PUBLI C HEARI NGS ( “MAY” PROVI SI ON) 1 / 2 PUBLI C HEARI NGS Information gathering position pre-assessment by PRAC Or During assessment Contribution to opinion making Or Transparency at end of procedure to explain recommendation 9
PUBLI C HEARI NGS ( “MAY” PROVI SI ON) 2 / 2 PUBLI C HEARI NGS Interactions with MAHs “request” for confidential discussions at PRAC “right of defence” during procedure transparency during procedure: release of assessment reports need for additional information gathering 10
RAPPORTEUR APPOI NTMENT Rapp/ Co-Rapp appointed by PRAC taking into account existing expertise in the MS Close collaboration with CHMP Rapp / RMS Process influenced by origin? CAP / NAP / Safety Concern Requirem ent for independence from prim ary evaluation 11
PRAC POSSI BLE OUTCOME Variation Suspension Revocation Non-renew al PASS studies Risk Minim isation Measures 12
Announcem ent Prelim inary Subm ission of Notification Com m ents Updated start of procedure Assessm ent Assessm ent relevant data + MS AR in w riting Assessm ent in W RI TI NG PRAC PRAC PRAC PRAC Meeting Meeting Meeting Meeting 1 5 days Day 1 Day 2 0 Day 3 5 Day 4 5 Day 0 Day 6 0 • Consideration of the • Public Hearing? • Public hearings held; matter; • Non-Public hearing; • Temporary • Tem porary measures; m easures needed? • Discussion; • Preliminary • Public Hearing ? discussion; PRAC • W hich data to ask? PRAC RECOMMENDATION • W hen & how to Recom m endation submit? 13
PRAC recom m endations PRAC recom m endations At least one Non CAPs CAPs CG CHMP 3 0 days 3 0 days ( or shorter) ( or shorter) Opinion by Opinion by Adoption of Opinion ( variation, suspension, revocation, consensus Majority refusal of renew al) Adoption of Opinion ( variation, suspension, revocation, refusal of renew al) + Tim etable for MS I m plem entation EC Commission Decision 14
Tem porary m easures at any tim e Tem porary m easures im plem ented im m ediately Overall procedure 6 m onths ( MAX) Recall from : Am endm ent( s) to - w holesaler the PI - retail ( restriction of ( including pharm acy and use( s) ) general sale) - hospitals Exam ples: - patients Suspension of: Prohibition - MA of - Marketing use/ supply 15
Quo Vadis Article 3 1 and Article 2 0 Pharmacovigilance + urgency 107(i) Pharmacovigilance without urgency PRAC + Public hearing + Art.32 procedure 16
Mapping of existing product cases Mapping of existing product cases CURRENT NEW PRODUCT I SSUE/ ACTI ON PRAC? CHMP? LEGI SLATI ON LEGI SLATI ON CLOPI DOGREL Quality issue related to Art 20 ( x8) Art 2 0 No Yes PRODUCTS inspections SOMATROPI N I ncrease in m ortality and Art 2 0 ( x3 ) + Art Art 3 1 Yes Yes risk of cancer in children 1 0 7 PANDEMRI X - Narcolepsy in paediatric population Art 2 0 Art 1 0 7 i Yes Yes - Prohibition of use in SE and FI BI PHOSPHONATE Class review ( stress Art 2 0 ( x9 ) + Art Art 3 1 Yes Yes fractures) 3 1 MODAFI NI L - Several safety issues - Changes to PI at national level Art 3 1 Art 3 1 Yes No - Benefit/ Risk review OCTAGAM - I ncrease num bers of TEEs Art 1 0 7 Art 1 0 7 i Yes No - Suspension of MA in DE and SE NI MESULI DE Suspension of the MA in I E due to cases of fulm inant Art 1 0 7 Art 1 0 7 i Yes No hepatic failure SI BUTRAMI NE - Prelim inary results of the SCOUT study - I ncreased cardiovascular Art 1 0 7 Art 1 0 7 i Yes No risk - Consideration of suspension from DE 17
18 Questions
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