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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/
TAIEX, Istanbul, April 19th, 2011 3
TAIEX, Istanbul, April 19th, 2011 4
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
TAIEX, Istanbul, April 19th, 2011 7
Main industry obligations - 2
Others
– Reporting following suspension or withdrawal of
the Marketing Authorisation
– Company sponsored post-authorisation safety
studies
TAIEX, Istanbul, April 19th, 2011 8
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
TAIEX, Istanbul, April 19th, 2011 9
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...
TAIEX, Istanbul, April 19th, 2011 10
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)
TAIEX, Istanbul, April 19th, 2011 11
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
TAIEX, Istanbul, April 19th, 2011 13
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!
TAIEX, Istanbul, April 19th, 2011 14
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
TAIEX, Istanbul, April 19th, 2011 15