Third Stakeholders forum on the I m plem entation of the new pharm - - PowerPoint PPT Presentation

An agency of the European Union

Presented by: Anthony Humphreys London, 20 October 2011

Third Stakeholders forum

• n the

I m plem entation of the new pharm acovigilance legislation

URGENT UNION PROCEDURE (including concept of public hearings)

2

SAFETY REFERRALS SAFETY REFERRALS

A r t i c l e 3 1

A r t i c l e 1 7

A r t i c l e 2 Article 3 6

TODAY TODAY’ ’S TOOLKIT S TOOLKIT

3

SAFETY REFERRALS SAFETY REFERRALS

A r t i c l e 2

TOMORROW’S TOOLKIT

Article 3 6 A r t i c l e 3 1

A r t i c l e 1 7 ( i )

4

The Future: 1 0 7 ( i) NAP’s + ( MRP/ DCP’s) + CAP’s

1 / 2

MS/ EC

when urgent action is considered necessary + criteria

HCP’s Public MAHs Written + / - public hearing 60 days (PRAC) 30 days (CHMP / CG) I nitiated by Tim e Lim it Consultation

5

PRAC recom m endation CHMP Opinion OR CG agreem ent Com m ission Decision

(CHMP - All) (CG – no agreement)

 + / - Tem porary m easures  Final m easures

Until definitive decision may suspend marketing + use product

The Future: 1 0 7 ( i) NAP’s + ( MRP/ DCP’s) + CAP’s

2 / 2

Outcom e Urgent Action to protect public health NO RE-EXAMI NATI ON

6

Article 1 0 7 ( i)

Pharm acovigilance activities Pharm acovigilance activities – Data driven Urgency Urgency – W ho decides? 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

I nitiation +

7

W EB PORTAL ANNOUNCEMENT

Stake Holders (not just industry)

Questions + MS AR w ill be public Triage data subm itted Time limit to submit < 30 days Announcem ent intention to have a public hearing: data gathering

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TI ME LI MI T

Post data collection w ritten + / - oral PRAC 6 0 days No clock stop

Legislation does not foresee clock stop “URGENT” UNION PROCEDURE Challenge to the assessment teams Robustness of opinion quality process

3 0 days CHMP / CG No clock stop

9

PUBLI C HEARI NGS PUBLI C HEARI NGS ( “MAY” PROVI SI ON) 1 / 2

 position pre-assessment by PRAC  During assessment Contribution to opinion making Or Or  Transparency at end of procedure to explain recommendation

 Information gathering

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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

PUBLI C HEARI NGS PUBLI C HEARI NGS ( “MAY” PROVI SI ON) 2 / 2

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RAPPORTEUR APPOI NTMENT

 Rapp/ Co-Rapp appointed by PRAC taking into account existing expertise in the MS  Close collaboration with CHMP Rapp / RMS Requirem ent for independence from prim ary evaluation Process influenced by origin? CAP / NAP / Safety Concern

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 Variation  Suspension  Revocation  Non-renew al  PASS studies  Risk Minim isation Measures

PRAC POSSI BLE OUTCOME

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Notification + MS AR

• Consideration of the

matter;

• Tem porary

m easures needed?

• Public Hearing?
• W hich data to ask?
• W hen & how to

submit? Announcem ent

start of procedure

Subm ission of relevant data in W RI TI NG

• Public Hearing?
• Temporary

measures;

• Preliminary

discussion;

• Public hearings held;
• Non-Public hearing;
• Discussion;

Prelim inary Assessm ent Updated Assessm ent

PRAC Recom m endation

PRAC RECOMMENDATION

Assessm ent

PRAC Meeting PRAC Meeting PRAC Meeting PRAC Meeting

Com m ents in w riting

Day 0 Day 1 Day 3 5 Day 4 5 Day 6 0

1 5 days

Day 2 0

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Adoption of Opinion ( variation, suspension, revocation, refusal of renew al) + Tim etable for MS I m plem entation Adoption of Opinion ( variation, suspension, revocation, refusal of renew al) 3 0 days ( or shorter)

PRAC recom m endations PRAC recom m endations

Non CAPs

Opinion by consensus Opinion by Majority

EC

Commission Decision

At least one CAPs

CG CHMP

3 0 days ( or shorter)

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Tem porary m easures im plem ented im m ediately Overall procedure 6 m onths ( MAX)

Tem porary m easures at any tim e

Suspension of:

• MA
• Marketing

Prohibition

• f

use/ supply

Recall from :

• w holesaler
• retail

( including pharm acy and general sale)

• hospitals
• patients

Am endm ent( s) to the PI ( restriction of use( s) )

Exam ples:

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 Pharmacovigilance + urgency  107(i)  Pharmacovigilance without urgency  PRAC

+

Public hearing

+

Art.32 procedure

Quo Vadis Article 3 1 and Article 2 0

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No Yes Art 1 0 7 i Art 1 0 7

• Prelim inary results of the

SCOUT study

• I ncreased cardiovascular

risk

• Consideration of

suspension from DE SI BUTRAMI NE No Yes Art 1 0 7 i Art 1 0 7 Suspension of the MA in I E due to cases of fulm inant hepatic failure NI MESULI DE No Yes Art 1 0 7 i Art 1 0 7

• I ncrease num bers of

TEEs

• Suspension of MA in DE

and SE OCTAGAM No Yes Art 3 1 Art 3 1

• Several safety issues
• Changes to PI at national

level

• Benefit/ Risk review

MODAFI NI L Yes Yes Art 3 1 Art 2 0 ( x9 ) + Art 3 1 Class review ( stress fractures) BI PHOSPHONATE Yes Yes Art 1 0 7 i Art 2 0

• Narcolepsy in paediatric

population

• Prohibition of use in SE

and FI PANDEMRI X Yes Yes Art 3 1 Art 2 0 ( x3 ) + Art 1 0 7 I ncrease in m ortality and risk of cancer in children SOMATROPI N Yes No Art 2 0 Art 20 ( x8) Quality issue related to inspections CLOPI DOGREL PRODUCTS CHMP? PRAC? NEW LEGI SLATI ON CURRENT LEGI SLATI ON I SSUE/ ACTI ON PRODUCT

Mapping of existing product cases Mapping of existing product cases

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Questions