animal health industry - pharmacovigilance requirements

Animal Health Industry - Pharmacovigilance Requirements

Declan O’ Brien,

Managing Director, IFAH-Europe

TAIEX, Istanbul, April 19th, 2011 1

Content

IFAH-Europe

References: legal basis, Volume 9B and Guidelines

Main industry obligations

Role of Qualified Person for PharmacoVigilance

PharmacoVigilance System & Inspections

Industry Experience with Inspections

Adverse event reporting

Conclusions

TAIEX, Istanbul, April 19th, 2011 2

IFAH-Europe

International Federation for Animal Health-Europe:

– The federation representing manufacturers of veterinary medicines, vaccines and other animal health products in Europe

14 corporate and 20 national association members

Membership covers 90% of the European market for veterinary products

For more information: http://www.ifaheurope.org/

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References

Legal basis:– Directive 2004/28/EC of the European Parliament and of the

Council of 31 March 2004 amending Dir. 2001/82/EC on the Community code relating to veterinary medicinal products (Official Journal L 136, 30.04.2004 p. 58)

– Regulation 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Official Journal L 136, 30.04.2004, p. 1)

– Commission Eudralex Volume 9B - Note: Vol. 9B remains pending; in the meantime, Vol. 9 (June 2004) remains valid for VMPs

EMA/CVMP guidelines

VICH guidelinesTAIEX, Istanbul, April 19th, 2011 5

GL # and title VICH step Status in the EU

GL 24: PhV: Management of adverse event reports (AERs)

Step 7Oct. 2007

Implementation pending final GL 35

GL 29: PhV: Management of PSURsStep 7May 2006

Implementation: June 2007

GL 30: PhV: controlled list of terms Step 7 Implementation pending final GL 35

GL 35: PhV: Electronic Standards for the Transfer of Regulatory information

Step 5

Consultation in the 3 regions closed (15/03/2011)Aim: to provide general framework for implementation of HL7

GL42: PhV: Data Elements for Submission of Adverse Event Reports

Step 7Oct. 2007

Implementation pending final GL 35

Status of VICH Guidelines in the EU

http://www.vichsec.org/en/topics.htm#6 TAIEX, Istanbul, April 19th, 2011 6

Main industry obligations - 1

Obligations introduced in 2004– Detailed Description of the PV system (DDPS) in the

Marketing Authorisation (MA) dossier

– Risk Management system

– Electronic reporting

Existing obligations that received greater emphasis– Increased frequency of submission of periodic safety

update reports (PSURs)

– Additional channels for the collection of PV data, e.g.: Reporting suspected transmission of infectious agents via VMPs Animal owners/breeders encouraged to report via healthcare

professionals

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Main industry obligations - 2

Others

– Reporting following suspension or withdrawal of

the Marketing Authorisation

– Company sponsored post-authorisation safety

studies

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Role of the company Qualified Person for PharmacoVigilance (QPPV)

Establishment and maintenance of the company PV system (that can be inspected)– QPPV = contact point for inspection

Reporting: adverse events / PSURs

Company sponsored post-authorisation studies

Continuous overall PV evaluation

Answer additional request from CAs

Delegation of QPPV responsibilities is possible:– Internal delegation / must be well documented and

overseen by the QPPV

– Contractual arrangements with external organisation

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PharmacoVigilance (PV) system and Inspection

Described in the Commission GL on ‘Monitoring of compliance with PV regulatory obligations and PV inspections for Veterinary Medicinal Products (VMP)’ (March 2007)http://ec.europa.eu/health/documents/eudralex/vol-9/index_en.htm

GL provides information on:

–Content of the Detailed Description of the PV system (Standard Operating Procedures (SOP), training, database, Quality Assurance (QA) auditing...)

–Monitoring of compliance by Competent Authorities (CA’s)

–Inspection: routine (MS) or targeted (MS or CVMP)

–Regulatory action, e.g. education, warning, MA to be amended (variation) or suspended...

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Industry Experience with inspections

Several MSs have now carried out routine inspections since 2006

Attention brought to archiving and training

IFAH-Europe promotes:– Data exchange between CAs to avoid duplications (role of

EMA Inspection sector)

– Proportionate approach based on size of the inspected site (human/veterinary and mother company/subsidiary)

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Adverse event reporting - 1

Industry obligations for expedited (15 day) cases

– Report EU cases to the country where the case occurred

– Report non-EU (3rd country) cases to EV Vet only

– National reporting requirements still apply: Having to comply with several databases (national

and EU) is very challenging for industry

EV Vet (EudraVigilance Vet): central database set-up by EMA:– Contains adverse events reports to all veterinary

medicines authorised in the EU, i.e. national, MRP/DCP and CP

– Reports received from CAs and industryTAIEX, Istanbul, April 19th, 2011 12

Adverse event reporting - 2

Industry obligations for Periodic Safety Update Reports (PSUR):

– PSUR content: Focus on scientific evaluation of benefit/risk balance Line listing containing all cases

– Presented in a searchable and sortable format, e.g. pdf or Excel

– PSUR format: electronic format encouraged for submission to national Competent Authorities and EMA (pdf sent via Eudralink)

– Purely national MAs: English language must be accepted by all Competent Authorities

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Adverse event reporting - 3

PSURs calendar:

– Every 6 months till product on the market

– Once on the market: Every 6 months for first 2 years Every 12 months for the next 2 years Every 3 years

Content & timing needs careful consideration when the legislation is reviewed, e.g. only start clock from when product is placed on the market!

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Conclusions

IFAH-Europe is committed to PV

– Industry Good Veterinary PhV Best Practice Guide – GVPPG

- 2nd edition expected off the press shortly!

Industry has obligations including appointment of a

QPPV & a well developed PV system

Adverse event reporting obligations also exist

– Content & timing should be reviewed as part of legislative

review

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