Asphanews November 2014

Read about the most recent changes in the dynamic fields of PhV, Regulatory Affairs, and Drug Development.

Read about the most recent changes in the dynamic fields of PhV, Regulatory Affairs, and Drug Development.
November 11, 2014

Pharma Bridge:
Your best gateway to the European

is a proud member of Euro Pharma Bridge.

Euro Pharma
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.

The partners
and provided services are:



Contact us
at for further information on Euro Pharma Bridge.


EMA publishes
final version of Biosimilar guideline

On 29
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.

Use of
foreign comparators

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.

For further details click here or contact


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
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.

     For further
    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.

      About EURS

      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

      EMA has published a new guideline
      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
      medicines developers.

      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,
      • introduces
        increased flexibility into the application process,
      • incorporates new
        study concepts, such as extrapolation of results and modelling,
      • clarifies
        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

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