Regulatory Approval - Labeling

Labeling

For most Life Sciences organizations, the multilingual labeling process is
experienced as painful, slow and error-prone. In Europe, global labeling
becomes a multilingual labeling issue considering the English to non-English
ratio of source to target language for labeling submissions.

SDLの連絡先

医薬品業界向け多言語XML要件に対処するベストプラクティス
Global Regulatory Challenges Drive Multilingual Regional Solutions

English to Non-English ratio in % for global labeling by region

Since January 2007, the European Medicines Agency (EMEA) requires labeling Documents to be completed in 23 languages for the centralized procedure (CP). As a result, for any new chemical entity (NCE) following the CP, 96% of all content is created in a language other than English. The same multilingual volume is handled in the decentralized (DCP) and mutual recognition procedure (MRP).

But new applications only represent half of the multilingual workload though. There are many reasons- besides the growing complexity of today’s drugs - why post marketization efforts are increasingly triggering additional multilingual work for variations, renewals and line extensions.

Especially in the CP, where deadlines are determined by the monthly EMEA CHMP meetings, unpredictable multilingual workload is a high risk. If 1 out of 23 language deliveries is late then the submission is delayed by at least one month. That’s why leading pharmaceutical companies implemented the SDL Global Information Management solutions to protect substantial revenue streams.

PIM – XML based Labeling

The imminent introduction of PIM further increases the risk of missing the CHMP deadlines as PIM imposes substantial process changes on how affiliates will work tomorrow. This is in terms of how PIM is coordinated, translated, reviewed, discussed with member states and passed between labeling systems and the translation process.

SDL has pioneered PIM submissions together with the early adopters of the upcoming standard. It is proven that SDL allows you to mitigate the risk for PIM introductions, providing the migration path from QRD templates to PIM submission.

Efficient Multilingual Labeling

The SDL solutions cure multiple labeling problems allowing for:

Twice as fast translations compared to traditional methods
More consistent translations
Better translation quality with built-in quality reflecting the current approval process
Significantly reduction of agency comments as proven by SDL clients
Successful discussions with the local authorities
Streamlining the internal and external translation review process
Improved translation outsourcing processes
A smooth transition and migration to the PIM process

SDL enables a new professional multilingual process which equips organizations for future growth combined with cost controls.

Webex

医薬品業界向け多言語XML要件に対処するベストプラクティス

規制当局によって、現地語での情報がますます求められるようになってきています。業界リーダーには、欧州・中東・アフリカ地域のCentral Procedure（PIM）のマイルストーンを達成することが要求されます。それでも、多言語でのPIM申請を成功させるには、多数の課題が待ち受けています。

ホワイトペーパー

Global Regulatory Challenges Drive Multilingual Regional Solutions

Best Practices for Addressing Labeling Language Requirements