Commission

• Union procedure on the preparation, conduct and
  reporting of EU pharmacovigilance inspections
  Table of contents
  1.
• Record management and archiving ....................................................................... 12

  References ................................................................................................ 12
  Appendix 1 ?Pharmacovigilance inspection report .................................... 13
  Appendix 2- Inspection overview (IO) ...................................................... 14
  Appendix 3- Pharmacovigilance inspection outcome sharing .................... 15
  Appendix 4- Classification of inspection findings....................................... 16

  Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
  inspections
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  1.

• Guidelines on the interpretation of legislative pharmacovigilance
  requirements are published in the adopted good pharmacovigilance practices (GVPs) Module III ?
  pharmacovigilance inspections.
• Preparation of a risk-based programme for pharmacovigilance inspections is presented in the Union
  procedure on the coordination of EU pharmacovigilance inspections.
• Scope
  This procedure constitutes a guideline in preparing, conducting and reporting national competent
  authority (NCA) pharmacovigilance inspections and outlines the steps taken of the Committee for
  Medicinal Products for Human Use (CHMP) requested pharmacovigilance inspections.
• Those are covered under the Union procedure on the
  management of pharmacovigilance inspection findings which may impact the robustness of the benefitrisk profile of the concerned medicinal products.
• Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
  inspections
  EMA/INS/PhV/192230/2014

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  3.

• Preparation
  Preparation encompasses those activities undertaken after the selection of an MAH, or third party, for
  a pharmacovigilance inspection and prior to inspection conduct.
• For the selection of involved
  parties for CHMP requested inspections, refer to the Union procedure on the coordination of EU
  pharmacovigilance inspections.
• Announcement communications could include, for example, the

  Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
  inspections
  EMA/INS/PhV/192230/2014

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  name of the inspector(s), MAH, the objectives and nature of the inspection (i.e.

• Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
  inspections
  EMA/INS/PhV/192230/2014

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  ?

  Feedback from other competent authority functions, in particular pharmacovigilance assessors.

• Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
  inspections
  EMA/INS/PhV/192230/2014

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  ?

  If teleconference(s) are planned during the inspection with experts, assessors, MAH personnel
  located off site etc.

• ?

  Union procedure on the management of pharmacovigilance inspection findings which may impact
  the robustness of the benefit-risk profile of the concerned medicinal products.

• Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
  inspections
  EMA/INS/PhV/192230/2014

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  Appendix 1 ?Pharmacovigilance inspection report
  Click here for the template.

• Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
  inspections
  EMA/INS/PhV/192230/2014

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  Appendix 2- Inspection overview (IO)
  Click here for the template.

• Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
  inspections
  EMA/INS/PhV/192230/2014

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  Appendix 3- Pharmacovigilance inspection outcome sharing
  Click here for the template.

• Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
  inspections
  EMA/INS/PhV/192230/2014

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• Abstract
  We examine rating behaviour after the introduction of new regulations regarding Credit Rating
  Agencies (CRAs) in the European securitisation market.
• There is empirical evidence of rating catering in the securitisation market in the pre-GFC period (He et al.,
  2012; Efing and Hau, 2015).
• Competition among
  CRAs could diminish ratings quality (Golan, Parlour, and Rajan, 2011) and promotes rating shopping by
  issuers resulting in rating inflation (Bolton et al., 2012).
• This paper investigates the impact of the post-GFC regulatory changes in the European
  securitisation market.
• In 2011, in addition to the creation of
  European Securities and Markets Authority (ESMA), a regulatory and supervisory body for CRAs was
  introduced.
• We examine how rating behaviours have changed in the European securitisation market after the
  introduction of these new regulations.
• We utilise the existence of multiple ratings and rating agreements between
  CRAs to identify the existence of rating shopping and rating catering, respectively (Griffin et al., 2013; He
  et al., 2012; 2016).
• We find that the regulatory changes have been effective in tackling conflicts of interest between issuers
  and CRAs in the structured finance market.
• Rating catering, which is a direct consequence of issuer and
  CRA collusion, seems to have disappeared after the introduction of these regulations.
• There is empirical evidence of rating catering in the securitisation market in
  the pre-GFC period (He et al., 2012; Efing and Hau, 2015).
• Competition among CRAs could diminish ratings quality (Golan, Parlour,
  and Rajan, 2011) and promotes rating shopping by issuers resulting in rating inflation (Bolton et
  al., 2012).
• This paper investigates the impact of the post-GFC regulatory changes in the European
  securitisation market.
• In 2011, in addition
  to the creation of European Securities and Markets Authority (ESMA), a regulatory and
  supervisory body for CRAs was introduced.
• We find that the regulatory changes have been effective in tackling conflicts of interest
  between issuers and CRAs in the structured finance market.
• Rating catering, which is a direct
  consequence of issuer and CRA collusion, seems to have disappeared after the introduction of
  these regulations.
• Investors who previously demanded higher spreads for rating agreements for a
  multiple rated tranche, did not consider the effect of rating harmony as a risk in the post-GFC
  period.
• Regarding rating shopping, we find that the effectiveness of the changes has been limited,
  potentially for two reasons.
• Additionally, we also find that rating over-reliance might still be an issue, especially
  Rating catering is a broad term and it can involve rating shopping.
• They re-examine the rating shopping and rating
  catering phenomena in the US market by looking at the post-crisis period between 2009 and 2013.
• Using 622 CDO tranches, they also observe the existence of rating shopping and the diminishing
  of the rating catering.
• Firstly, our main focus is the EU?s CRA Regulation and its effectiveness in reducing
  rating inflation and rating over-reliance.
• To the best of our knowledge, this paper is the first to
  examine the effectiveness of the EU?s CRA regulatory changes on the investors? perception of
  rating inflation in the European ABS market.
• Hence, the coverage and quality of our dataset constitutes significant addition
  to the literature and allows us to test the rating shopping and rating catering more authoritatively.
• The following section reviews the literature
  on securitisation concerning CRAs and conflicts of interest, and outlines the regulatory changes
  introduced in the post-GFC period.
• Firstly, ratings became ever more important as the Securities and
  Exchange Commission (SEC) 5 began heavily relying on CRA assessments for regulatory purposes
  (i.e.
• the investment mandates that highlight rating agencies as the main benchmark for investment
  eligibility) (SEC, 2008; Kisgen and Strahan, 2010; Bolton et al., 2012).
• issuers) as one of the main explanations for the rating inflation (He et al., 2011; 2012; Bolton
  et al., 2012; Efing and Hau, 2015).
• Bolton et al., (2012) demonstrate that competition
  promotes rating shopping by issuers, leading to rating inflation.
• The last phase, CRA III, was implemented in mid-2013 and involves an additional
  set of measures on reducing transparency and rating over-reliance.
• As mentioned above, rating inflation can be caused by rating shopping
  In order to be eligible to use the STS classification, main parties (i.e.
• The higher the difference in the number of ratings for a
  given ABS tranche, the greater the risk of rating shopping.
• Alternatively, the impact of the new
  regulations could be limited when it comes to reducing rating shopping.
• This is because, firstly,
  the conflict of interest between securitisation parties is not necessarily the sole cause for the
  occurrence of rating shopping.
• L is a set of variables (Multiple ratings, CRA reported, Rating agreement) that
  we utilise interchangeably to capture the rating shopping and rating catering behaviour.
• Hence, issuers are incentivised to report the highest possible rating and
  ensure each additional rating matches the desired level.
• All in all, our results suggest that
  the new stricter regulatory measures have been effective in tackling conflicts of interest and
  reducing rating inflation caused by rating catering.
• Self-selection might be a concern in analysing the impact of the
  new measures and investors? response with regard to the rating inflation.
• This
  result is in line with the earlier findings suggesting that regulatory changes have reduced investors?
  suspicion of rating inflation and increased trust of CRAs.
• Conclusion
  Several regulatory changes were introduced in Europe following the GFC aimed at tackling
  conflicts of interest between issuers and CRAs in the ABS market.
• Utilising a sample of 12,469
  ABS issued between 1998 and 2018 in the European market, this paper examined whether these
  changes have had any impact on rating inflations caused by rating shopping and rating catering
  phenomena.
• We find that the
  effectiveness of the changes has been more limited on rating shopping potentially for two reasons.
• Tranche Credit Rating is the rating reported for a tranche at launch.

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