ata 55 chicago 2014 - regulatory translation of generic medication product information in the...

© 2014 Nova Language Services

GENERIC MEDICATION PRODUCT INFORMATION

REGULATORY TRANSLATION IN THE EUROPEAN UNION

Diana SanchezLanguage and Training Consultant07/11/2014

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



CONTENTS

I. BackgroundII. European legislation requirements for

generic medication approvalIII. 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. FAQsVI. Conclusion



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



REGULATED MARKETS

United StatesEuropean Union Japan Australia, New Zealand (ANZ)

EMERGING MARKETS

Rest of the world(excluding ANZ)

BACKGROUND



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



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



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



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.



• 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:



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



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



© 2014 Nova Language ServicesSmPC AND PIL

SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)

US : Prescribing InformationPHYSICIANS: Specialized, high register

PATIENT INFORMATION LEAFLET (PIL)

US English: Package InsertPATIENTS: Simple writing, free from technical jargon

Same information. Different structure. Different wording.



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.



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



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



EDQM STANDARD

TERMS

Names of dosage forms, containers and routes of administration are standardised in European languages:

http://www.edqm.eu/StandardTerms/

Subscription required



MEDRA

MedDRA = Medical Dictionary for Regulatory Activities: Adverse reaction dictionary organized by System Organ Class

Subscription required

Go to: http://goo.gl/bwUFex



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



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?



• 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



• 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



REFERENCES

• http://www.fda.gov/

• http://www.ema.europa.eu

• http://www.ich.org

• http://www.edqm.eu/StandardTerms

• http://eutct.ema.europa.eu/


Thank youwww.nova-transnet.com

e-mail: [email protected]

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ata 55 chicago 2014 - regulatory translation of generic medication product information in the...

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