What does this mean for pharmaceutical companies?

1. W W W . I V O W E N . C O M
Clinical Trial Regulation EU No. 536/2014
What this Means for Pharmaceutical Companies?

2. Clinical Trial Regulation (No. 536/2014) will come into effect in 2018 and
presents some major changes to how clinical trial applications are
submitted and how clinical trials are conducted in the EU.
Clinical Trial Regulation EU No. 536/2014

3. The goal of the new Regulation is to create
an environment that is favourable to
conducting clinical trials in the EU, with the
highest standards of safety for participants
and increased transparency of trial
information.

4. Directive 2001/20/EC
(Current)
Multiple submission for one trial
(1 submission per each MS)
Double submission with a MSC: to NCA
and EC
Individual assessment by Each MSC with
no IT collaboration tool available
No Single MSC decision (NCA and ECs)
Limited EudraCT data availability to the
public

5. Regulation 536/2014
(New)
Single e-submission to all MSCs
Harmonised dossier for one trial
and e-submission of structured data and
documents by MSCs
Specific timeline
Joint assessment for PART I
facilitated by collaboration tool
Single MSC decisions
Single web-based EU portal
Distribution of the burden among users
View all CT relation information

6. 3 Years Transition Period
Directive 2001/20/EC (current)
to Regulation 573/2014
Starts when Regulation becomes applicable (~Oct 2018)
1st Year: Clinical Trials can be submitted under old/current (Directive) or new
(Regulation) system
2nd & 3rd Year: Trials authorised under old system can remain under that
system, New/initial Clinical Trials should comply with the Regulation System
All Clinical Trials to switch to the Regulation 3 years after implementation
(~Oct 2021)

7. Typical Documents to
be submitted
Part I: Cover letter (very important), EU AF, Protocol, IB, GMP
compliance documents, IMPD, Auxiliary Medicinal Product Dossier,
Scientific Advice, PIPs, and labelling, proof of payment, etc.
Part II: Recruitment arrangements, SI/ICF/ICF procedure, suitability
of the investigator, suitability of the facilities, proof of insurance
cover or indemnification, financial and other arrangement, proof of
payment, etc.

8. Part I Timetable Coordinated assessment
(also applies to Mono-national Clinical Trials)
Day 0: Validation
Day 26: Draft Part I Assessment Report made available by the RMS
(reporting MS) to the CMS
Day 38: All CMS share considerations
Day 45: RMS finalises the Part Assessment Report
Day 57: Sponsor submits response (w/n 12days)
Day 69: Co-ordinated assessment between MSs (12 days)
Day 76: RMS files conclusion (7days)

9. Part II Timetable National evaluation
D0: Validation
D45: Final assessment report from each MSC submitted
D57: Sponsor submits response
D76: Final assessment by the MSC shall be performed (w/n 19 days)

10. Part I and II can be submitted in parallel
(recommended)
or
You can submit Part I followed by Part II
(not less than 2 years after Part I)

11. Important
Notes
New MSs can only be added
after the notification date of
the initial authorisation
decision
Withdrawal of MS: the
whole application has to be
withdrawn and resubmitted

12. Transparency
EU Database will be
publically accessible
by default, with
exceptions justified
on any of the
following grounds:
Protection of personal data
Protection of commercially confidential
information in particular, taking into
account the MA status of the medicinal
product, unless there is an overriding
public interest in disclosure
Protecting confidential communication
between Member State in relation to the
preparation of the assessment report
Ensuing effective supervision of the
conduct trial Member States

13. Where can I find more information?
Information on Clinical trials – Regulation EU No 536/2014, General
information, Guideline EU Clinical Trial Portal and Database, Transparency,
Safety reporting, Clinical trials conducted outside the EU
https://ec.europa.eu/health/human-
use/clinical-trials/regulation_en

14. thankyou!

15. contact us
Ivowen Limited are fully equipped to submit for Clinical Trials
Applications on your behalf. Please contact us for more information
and for support of your dossier compilation or updates
W W W . I V O W E N . C O M
Tel. +353 (0) 52 6180664
Fax. + 353 (0) 52 6180665
Email: info@ivowen.com