Regulatory Translation of Generic Medication Product Information in the European Union Diana Sánchez, Nova Language Services This presentation will discuss European legislation requirements for generic medication approval and share general considerations on how to proceed when translating product information (SmPC), Patient Information Leaflets (PIL) and labeling. In order to obtain final approval from the European Medicines Agency, translators are required to closely follow previously existing templates, often adapting content with no source text in hand. We will illustrate translation adaptation examples, focusing on the quality control methods applied to ensure compliance, and cover regulatory requirement differences between the United States and Europe.

1. © 2014 Nova Language Services
GENERIC MEDICATION
PRODUCT INFORMATION
REGULATORY TRANSLATION
IN THE EUROPEAN UNION
Diana Sanchez
Language and
Training Consultant
07/11/2014

2. INTRODUCTION
• Multilingual communications and
translation company focused in the life
sciences sector since 1998
• Offices in Europe and the United States
• ISO 9001:2008 and EN 15038:2006
certified
• Over 1,500 in-country medical translators
REGULATORY TRANSLATIONS
© 2014 Nova Language Services

3. © 2014 Nova Language Services
CONTENTS
I. Background
II. European legislation requirements for
generic medication approval
III. General rules and considerations on
how to proceed when translating
generic medication SmPc, PIL and
labeling
IV. QRD templates, language style and
terminology references
V. FAQs
VI. Conclusion
REGULATORY TRANSLATIONS

4. © 2014 Nova Language Services
THE GLOBAL PHARMACEUTICAL INDUSTRY IS
EXPECTED TO BE WORTH MORE THAN $1
TRILLION
• North America (US,
Canada)
• Europe (European
Union, Eastern
Europe)
• Rest of the World (Asia
Pacific minus Japan,
ANZ, GCC, LATAM,
CEE, CIS)
• Japan
One of the MOST
highly regulated
industries
BACKGROUND
REGULATORY TRANSLATIONS

5. © 2014 Nova Language Services
REGULATED MARKETS
United States
European Union
Japan
Australia, New Zealand
(ANZ)
EMERGING MARKETS
Rest of the world
(excluding ANZ)
BACKGROUND
REGULATORY TRANSLATIONS

6. © 2014 Nova Language Services
BACKGROUND
One of the major
markets in the pharma
industry
The FDA regulates the
drug approval system in
United States
NDA, (ANDA) and 505
(b)(2) Applications
Hatch- Waxman Act
(1984), birth of the
generic industry in the
US
USA
REGULATORY TRANSLATIONS

7. © 2014 Nova Language Services
BACKGROUND
A medicinal product may
only be placed on the
market with a marketing
authorization
The marketing
authorization holder
must be established
within the EEA
The EMA regulates
marketing authorizations
through various
committees
EUROPEAN
UNION
REGULATORY TRANSLATIONS

8. © 2014 Nova Language Services
CENTRALIZED
PROCEDURE
A single application, a single evaluation
and a single authorization allowing
direct access to the single market of the
Community of 27 countries.
NATIONAL
AUTHORIZATIONS
Member states are responsible for
granting marketing authorizations for
medicinal products which are placed on
their markets, except for centralized
procedure authorized medicinal
products.
DECENTRALIZED
PROCEDURE
The applicant may make use of a
decentralized procedure and submit an
application to all the Member States
where it intends to obtain a marketing
authorization at the same time, and
choose one of them as reference
Member State (RMS).
MUTUAL RECOGNITION
PROCEDURE (MRP)
If the applicant has marketing
authorization in one member state and
wishes to obtain the same in other
member states, MRP is followed.
MARKETING
AUTHORIZATION
PROCEDURES
European Union
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9. © 2014 Nova Language Services
GENERIC
MEDICATION
APPROVAL
A GENERIC DRUG IS A MEDICINAL PRODUCT WITH THE
FOLLOWING CHARACTERISTICS:
• The patent of the
originator
medicine has
expired.
• It is
bioequivalent to
the originator
medicine.
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10. © 2014 Nova Language Services
• Translations of generic drug
documents should be true to
pre-existing published
translations for the originator
medicine (= reference product).
• Only differences (excipients,
containers, etc.) should be
translated.
GENERIC
MEDICATION
APPROVAL
EMA’S REQUIREMENTS FOR SmPC /PIL/LABELING
OF GENERIC DRUGS:
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11. © 2014 Nova Language Services
Obtain marketing
authorisations for
new medicinal
products
Manage variations to
pre-existing
marketing
authorisations (new
indications, new
pharmaceutical
forms, etc.)
Communicate with
health authorities:
EMA, National Drug
Agencies (AEMPS,
AFSSAPS, etc.)
REGULATORY
AFFAIRS
REGULATORY TRANSLATIONS

12. © 2014 Nova Language Services
EUROPEAN
MEDICINES
AGENCY
(EMA)
• Provides scientific advice to the
Community Institutions on all
matters relating to medicinal
products for human and
veterinary use.
• Coordinates the scientific
evaluation of the safety, efficacy
and quality of medicinal products.
• Organizes speedy, transparent
and efficient procedures for the
authorization, surveillance and
where appropriate, withdrawal of
medicinal products in the EU.
• Creates databases and electronic
communication facilities as
necessary to promote the rational
use of medicines.
Source: European Food Safety Authority
http://www.ema.europa.eu/ema
REGULATORY TRANSLATIONS

13. © 2014 Nova Language Services
© 2014 Nova Language ServicesSmPC AND PIL
SUMMARY OF PRODUCT
CHARACTERISTICS (SmPC)
US : Prescribing Information
PHYSICIANS: Specialized,
high register
PATIENT INFORMATION
LEAFLET (PIL)
US English: Package Insert
PATIENTS: Simple writing,
free from technical jargon
Same information. Different structure. Different wording.
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14. © 2014 Nova Language Services
QRD
TEMPLATES
The QRD templates on the EMA website
provide official wording for the summary of
product characteristics (SmPC), patient
information leaflet (PIL) and labeling (L).
The EMA and the national regulatory
agencies only accept documents written
or translated according to the Quality
Review Documents (QRD) and relevant
appendixes published by EMA.
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15. © 2014 Nova Language Services
QRD
TEMPLATES
Human
medicines
• QRD templates are constantly updated by the
EMA.
• To avoid the use of outdated templates, they
should always be downloaded from the EMA
website:
DIFFERENT QRD
templates for:
 Centralized
procedures
 Decentralized
and mutual
recognition
procedures
Go to: http://goo.gl/thV3q3
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16. © 2014 Nova Language Services
SMPC SECTION 5.1
Common text to
all SmPCs
{Information to
be filled in}
<To be selected
or deleted as
appropriate>
[Explanatory
note/guidance. To
be deleted]
QRD
TEMPLATES
Human
medicines
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17. © 2014 Nova Language Services
EDQM
STANDARD
TERMS
Names of dosage forms, containers and
routes of administration are standardised in
European languages:
http://www.edqm.eu/StandardTerms/
Subscription
required
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18. © 2014 Nova Language Services
MEDRA
MedDRA = Medical Dictionary for
Regulatory Activities: Adverse reaction
dictionary organized by System Organ Class
Subscription
required
Go to: http://goo.gl/bwUFex
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19. © 2014 Nova Language Services
QRD
TEMPLATES
Veterinary
medicines
• There is only one common QRD template
for all authorisation procedures
• The wording of the SPC and the package
leaflet is similar
Go to: http://goo.gl/Q7Mg6T
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20. © 2014 Nova Language Services
FAQs
• Reference product translations are in
PDF, but tracking the differences
between the originator SmPC and
the new original is required. What
should I do?
• Can I use CAT tools?
• The reference product follows an
older QRD template while the
generic SmPC follows the last
version. How should I proceed?
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21. © 2014 Nova Language Services
• Source document, only target reference
document, but no matching original to
target source document.
• Source file and translated document with
highlighted updates, comments, etc.
Translator is to match target to source.
• Source and target files, translator is to
review and make sure both match, but
refrain from making content or style
changes.
COMMON
CASE
SCENARIOS
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22. © 2014 Nova Language Services
• Detailed review of comments written by
several parties, insert to make sure target
file complies with regulatory requirements.
• Absolute consistency with the reference
product translations is required, but at the
same time, it must be completely true to
the original English file.
• Deliverables with track changes and clean
format.
COMMON
CASE
SCENARIOS
REGULATORY TRANSLATIONS

23. © 2014 Nova Language Services
REFERENCES
• http://www.fda.gov/
• http://www.ema.europa.eu
• http://www.ich.org
• http://www.edqm.eu/StandardTerms
• http://eutct.ema.europa.eu/
REGULATORY TRANSLATIONS

24. Thank you
www.nova-transnet.com
e-mail:
diana@nova-transnet.com
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© 2014 Nova Language Services