Pharma Bridge: Your best gateway to the European
Bridge is a strategic alliance between leader service providers to facilitate
European Market Access to pharmaceutical companies.
will be providing all the regulatory support to obtain the European marketing
authorisation, with other partners offering valuable services ranging from
market analysis to logistic and distribution.
and provided services are:
at email@example.com for further information on Euro Pharma Bridge.
final version of Biosimilar guideline
October 2014, EMA presented the final version of their guideline on
biosimilars. This document replaces the previous guidance document of 2005,
provides several clarifications and introduces one important change intended to
ease global development of biosimilars.
Undoubtedly, the biggest news of this guideline is
that for certain studies EMA will permit the use of foreign comparator
products. The guideline states that “it may be possible for an Applicant to
compare the biosimilar in certain clinical studies and in in vivo non-clinical
studies (where needed) with a non-EEA authorised comparator“, a move that
is aimed to reduce the duplication of unneeded clinical studies, thus “facilitating
global development of biosimilars“, as claimed by EMA on their website.
Principles of establishing biosimilarity
EMA has included a complete section on the topic of
biosimilarity principles, offering several clarifying statements.
Key principles and general guidance
The new guideline also provides refined general guidance
and several clarifications, such as: posology and route of administration of
biosimilar must be the same as the reference product. Deviations in strengths,
pharmaceutical form, formulation may be acceptable, but require justification.
Intended changes to improve efficacy are not acceptable, yet potential
improvements relevant for safety should be addressed.
effective date of this guideline is 30 April 2015, however applicants can
already apply some or all provisions of the guideline as of 29 October 2014.
updates guidance on European Union periodic-safety-update-report single
assessment for nationally authorised medicines
The European Medicines Agency (EMA) has updated its procedural guidance to ensure that marketing-authorisation
holders are prepared for the submission of periodic safety update reports (PSURs)
for nationally authorised medicines subject to European Union (EU) single
The single assessment of nationally authorised medicines is a
deliverable of the 2010 pharmacovigilancelegislation. It aims to harmonise and strengthen the review of the benefits and
risks of all medicines across the EU. PSUR single-assessment procedures
involving a combination of centrally authorised medicines and nationally
authorised medicines have been in place since April 2013.
The main changes are:
- All active substances or combinations of active substances in the EURD
list follow the single PSUR assessment procedure, including substances
registered through National procedure / MRP / DCP with DLP after after
September 1, 2014.
- For products registered by National procedure/ MRP / DCP included in
the EURD list it will also be required to send the PSUR to the EMA (Nees or
Gateway in eCTD format), CHMP, PRAC members (Member States where the product is
authorized) + PRAC Rapporteur (defined in EURD list).
- Regarding submission, the name of the zip to send via Gateway to the
EMA has changed (depending if it’s a centralized or national product) and the
submission envelope description of the eCTD sequence.
details click here:
offers a very competitive service for the creation and submission of PSUR´s.
Feel free to contact us for a proposal of our services.
First pharmaceutical submissions in eCTD format
registered at Medicines Control Council of South Africa
The Medicines Control Council (MCC) of South Africa has successfully used our partner’s EXTEDO’s reviewing and validation
tool for registering pharmaceutical submissions prepared in eCTD format for the
first time ever.
The successful registrations of an NCE (new chemical
entity) and a generic drug mark an important milestone in MCC’s efforts to
introduce the eCTD standard to South Africa.Currently the medicines approval process in African countries can take
as long as three years and the delays deny timely access of essential medicines
to the sick. South Africa is committed
to dramatically reduce registration times and in 2013 MCC launched its
reviewing and validation project. Hence,
South Africa is the first African country to start a time-effective reviewing
process and accept electronic submissions instead of paper-based
To enable the processing of electronic submissions MCC
selected an EXTEDO solution based on EURS (EXTEDO Universal Reviewing System) to validate,
import, and review electronic submission information sent by pharmaceutical
companies on electronic media. EURS is
in use at the European Medicines Agency and many other European regulatory
authorities. For implementation in South
Africa, regional requirements of MCC have been jointly worked out and have been
adopted within the solution.
EURS (EXTEDO Universal Review System, formerly
called EURS is Yours) is a multifunctional software solution that serves as an
overall eCTD validation and reviewing software tool. It reports whether a
submitted eCTD- or NeeS-based application conforms to the official eCTD format.
It is especially designed for the validation, acceptance, import, review and
maintenance requirements of the EMA (European Medicines Agency), the associated
national competent authorities (NCAs), and also of authorities outside of the
European Union, e.g. the Saudi FDA or the Swissmedic.
Contact us at eCTD@asphalion.comfor further information on EURS and other Extedo’s software
on the format and content of PIPs
The European Commission has published a revised guideline on applications for paediatric investigation plans , or PIPs, in the Official
Journal of the European Union. The new guideline is expected to facilitate the application process. It is intended for all
Since the European Paediatric Regulation came into force in 2007, pharmaceutical
companies have had a legal obligation to develop plans to evaluate medicines in
children (known as paediatric investigation plans) as part of the development
of all new medicines, unless they obtain an exemption (known as a waiver). In
some cases, a similar obligation also applies to medicines that are already
authorised in the European Union (EU).
The first guideline describing the format and content of applications for paediatric investigation
plans was released in September 2008.The Commission has conducted a review of
this guideline to take into account experience
gained as well as feedback received from medicines developers.
other elements, the new guideline:
- establishes key
elements that should be included in paediatric investigation plans,
increased flexibility into the application process,
- incorporates new
study concepts, such as extrapolation of results and modelling,
requirements for the compliance check.
For further details click here:
Asphalion has prepared and reviewed multiple PIP. If
you are interested in a free evaluation and estimation of the requirements,
please contact us at firstname.lastname@example.org