Periodic Safety Update Reports (PSURs) | Pepgra.com

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Periodic Safety Update Reports (PSURS) Dr. Nancy
Agens, Head, Technical Operations, Pepgra
Sales.cro_at_pepgra.com
I. INTRODUCTION
evaluation, it is possible to determine whether
any additional investigation for a particular
issue were required, or whether an action was
essential to safeguard the health of the general
public (for instance an update of the
information that has been offered to patients as
well as healthcare professionals.

• PSURs are pharmacovigilance documents that
  provide risk-benefit balance assessment.
• The notion of PSUR is to offer a wide and
  complex evaluation of risk-benefit balance of a
  medicinal product.
• PSUR reporting first came into existence in 1992.

III. PSUR ORIGIN AND RECOGNITION

• Purpose of PSUR is to provide an

• update of global safety experience with a
  specific pharmaceutical.
• It is imperative to consult the guideline on
  good pharmacovigilance practices (GVP) while
  preparing PSUR.
• MAHs are supposed to submit all

The notion of PSUR reporting is said to have
taken root from 1992. It has found recognition
and is noted at diverse platforms. This is also
inclusive of the International Conference of
Harmonization (ICH) and the European Union and
it has been noted that PSUR reporting has not
matched pace with the due developments that have
taken place in pharmacovigilance literature
search like electronic adverse event reporting,
and planning for risk management.During the year
2010, an awareness of such type has led to
alterations in European Legislation laying down
the needs for PSUR reporting. On the basis of a
study conducted in the past, regarding
determinants of safety associated regulatory
actions for bio-pharmaceuticals, it was found
that evaluations through PSUR contributed to
around 38 per cent of
PSURs in EU to the central PSUR repository.
II. PSUR WHAT IS IT?
Periodic Safety Update Reports (PSURs) are
nothing but pharmacovigilance Service documents
that are intended to offer an assessment with
regards to the risk-benefit balance of a
specific medicinal product at
time points that are predetermined,
following its authorization. The key idea of the
PSUR is to offer an extensive and
vital evaluation of the risk-benefit balance
of the product, while taking into
post-authorization regulatory actions
consideration novel or emerging
within a sample of bio-pharmaceuticals.
Furthermore, during the year 2010, it was
information related to safety in the context of
increasing information pertaining to benefits
and risks. The European Medical
found by that around 64 per cent of selection of
adverse drug reactions (ADRs) stemmed through
PSURs. The said two studies scrutinized the
contribution of PSURs to recognized safety
signals, that do not offer any insight into the
manner in which PSURs are responsible for the
purpose of safety monitoring, or the
Agency as well as other national
competent authorities evaluate information
that is contained within PSURs to
understand whether there were any new
risks recognized for a medicine and or / if
there has been a change in its benefit balance.
With the help of a PSUR
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percentage of PSURs that results in regulatory
action.
evaluation procedure for products that are
nationally authorized. However, the issues could
also be applicable to products that have been
authorized in a central manner1.
IV. PSUR PURPOSE
The onus of keeping track of the bio-
pharmaceutical products rests on the shoulders
of Marketing Authorization Holders (MAHs), once
they are in receipt of authorization for
marketing. It is well- known that MAHs are
continuously engaged in dialogue with regulators
to make sure that the appropriate strategies
are deployed to optimize the advantage to risk
ratio of their products. One of the key tools
that are put to use to enable the post-
VI. PSUR SUBMISSION
Legal necessities for PSUR submissions had been
setup through regulation (EU) No 1235/2010.
Directive 2010/84/EU and in commission
implementing regulation (EU) No. 520/2012. The
PSUR format adheres to the structure that has
been outlined in the Implementing Regulation
Article 35 and module VII of the guidelines of
good pharmacovigilance practices (GVP) offers
guidance on the preparation, submission and
evaluation of PSURs. The particular format is
mandated by law for nationally authorized
products (NAPs) and centrally authorized
products (CAPs). Marketing Authorization Holders
are supposed to submit PSURs as per the data
lock points that have been duly published within
the EURD list. The legislation brings in
derogation for routine PSUR reporting for
specific products. Till such time that there is
a particular condition within the authorization,
or it has been mentioned to the contrary in the
EURD list, there is no
authorization communication amongst
MAHs and regulators is the PSUR. The purpose of
PSUR is to offer an update of global safety
experience with a particular
pharmaceutical. This also includes data from
safety data from observational and
interventional studies, spontaneous reports
along with other information pertaining to
safety.The purpose of PSUR is also to
proactively analyse, present and assess novel or
altering safety related data from any source
assessed with regards to estimates of product
exposure, though the overall coverage of data
sources would have restrictions in terms of
practice.
need for routine PSUR reporting,
V. PSUR PREPARATION
particularly for medicinal products that have
been authorized as per the articles of Directive
2001/83/EC. As on 13th June, 2016, it is
necessary for
The preparation of PSUR is an arduous and
intricate procedure and requires much care and
consideration. Keeping in mind the fact that
PSURs are supposed to be prepared by MAHs, it is
imperative that they mandatorily consult the
guideline on good pharmacovigilance practices
(GVP) Module VII PSUR. Further, to
facilitate the proper and appropriate
preparation of the PSUR, the European Medical
Agency has created an explanatory note to GVP
module VII, that all MAHs are expected to
consult at the time of preparing periodic
MAHs for submit all PSURs within the EU to the
central PSUR repository by utilizing the
eSubmission gateway / web client. It is
compulsory for MAHs to utilize the PSUR
repository for centrally as well as nationally
authorized medications, irrespective of whether
it is following the single assessment of the EU
or a purely national process of assessment.
safety update reports. The proper preparation of
the PSUR will tackle particular problems in the
European Union