Managing translations for submissions in regulatory affairs – what is best practice?

Managing translations for submissions in regulatory affairs – what is best practice?

Few heads of regulatory affairs would dispute the complexity of compliance and regulation in the life sciences industry. Changing regulations puts greater pressure on regulatory professionals and makes the job of translating content for submissions ever more difficult, while the pressure to decrease time-to-market for life-saving new drug therapies grows all the time.

Regulations change so frequently in countries all the time, that there is an almost constant re-evaluation as to what is needed to be included in dossiers and what parts of the dossier require translation. Given such challenges, whether handling translations for submission dossiers, product information leaflets and more, what constitutes best practice in managing translations in today’s regulatory affairs environment?

The growing challenge of international distribution

Preparing existing and new products for distribution in international markets is a major challenge, with significant differences between regions and countries. This affects product information and clinical documentation translations, a critical component of getting life sciences products approved for licence and distribution in individual markets. Underestimating or cutting corners on this could lead to errors that delay market access, a product recall, or even a threat to patient safety.

As global ambitions grow, companies need a reliable means of managing translations of regulatory materials which is consistent in its quality controls and monitoring whether it be for Europe, Africa, Asia or the Americas. It’s essential that companies have a robust plan for managing this.

Making consistency a priority

Previously it has been common for life sciences firms to devolve responsibility for individual market translations of registration documents to local teams who manage requirements with the help of local translation agencies. This approach brings with it a number of challenges, which in turn risk rising costs and potential delays to market access - not to mention inconsistencies in the quality, look and feel of translated content.

Satellite operations in overseas markets are typically staffed by sales and marketing people, who often lack the capacity, project management or linguistic skills to keep on top of regulatory content translations.

Even in Europe, an established region for understanding and managing regulatory requirements including certified local translations, the demands are so substantial and in such a constant state of flux, that dedicated personnel, experience and skills are needed to maintain compliance.

There are currently 24 languages to provide for, for the EU’s centralised authorisation procedure. Broadening out to include non-EU countries increases Europe’s translation burden to 30-plus languages. Add in Asia, Africa and Latin America, and the translation requirement grows even further.

The tools and skills needed for smart translation

As firms’ global ambitions grow, so their translation requirements multiply, and the case builds for a holistic approach to tracking evolving international regulatory requirements, and for delivering timely and accurate local translations for each market.

This requires a centralised, systematic approach to the coordination and execution of translation projects, offering scope for greater consistency, cost-efficiency and a clear line of sight across workloads and upcoming demands.

Managed regulatory translation service providers who specialise in life sciences content will have pools of resources, skills and experience that companies can count on and become a huge asset as a result. They will have found ways to accelerate delivery – for example by harnessing translation memory technology: which can automatically draw on specialist, agreed phrasing and terminology in the target language, from previous use cases. The longer an organisation continues to use the same provider to manage translations, the faster the output.

In addition to including each firm’s specific terminology and references, translation memories also benefit from regional and country-specific templates and glossaries of standard terms and phrasing - including EMA’s Quality Review of Documents (QRD) human product information templates, for instance.

Although next-generation automation using artificial intelligence (AI) are still evolving, in time such capabilities will add significant value. Increased automation will decrease cost and turnaround times even further.  A good translation partner will have this kind of technology built into its technology automation roadmap, for when tools are deemed mature and robust enough to meet the acutely sensitive need for quality and accuracy in the translation of life sciences/medical content.

The business benefits of smart translation

Firms should try and change how they perceive regulatory translation activities. When done well they can offer many business benefits – access to new revenue streams, keeping unnecessary risks to product supply at bay - and are certainly not an unwelcome cost burden.

Assuming a more strategic position on regulatory translations, and developing a robust, centralised global capability, offers the best chance of keeping control over spiralling costs and requirements. This should include continuous, coordinated access to the right expertise, quality consistency and capacity, plus the ability to harness the benefits of technology-enabled automation as appropriate.

About the author

Nancy Pollini is director of strategic accounts for language services at AMPLEXOR Life Sciences.

Managing translations for submissions in regulatory affairs – what is best practice?

Few heads of regulatory affairs would dispute the complexity of compliance and regulation in the life sciences industry. Changing regulations puts greater pressure on regulatory professionals and makes the job of translating content for submissions ever more difficult, while the pressure to decrease time-to-market for life-saving new drug therapies grows all the time.

Regulations change so frequently in countries all the time, that there is an almost constant re-evaluation as to what is needed to be included in dossiers and what parts of the dossier require translation. Given such challenges, whether handling translations for submission dossiers, product information leaflets and more, what constitutes best practice in managing translations in today’s regulatory affairs environment?

The growing challenge of international distribution

Preparing existing and new products for distribution in international markets is a major challenge, with significant differences between regions and countries. This affects product information and clinical documentation translations, a critical component of getting life sciences products approved for licence and distribution in individual markets. Underestimating or cutting corners on this could lead to errors that delay market access, a product recall, or even a threat to patient safety.

As global ambitions grow, companies need a reliable means of managing translations of regulatory materials which is consistent in its quality controls and monitoring whether it be for Europe, Africa, Asia or the Americas. It’s essential that companies have a robust plan for managing this.

Making consistency a priority

Previously it has been common for life sciences firms to devolve responsibility for individual market translations of registration documents to local teams who manage requirements with the help of local translation agencies. This approach brings with it a number of challenges, which in turn risk rising costs and potential delays to market access - not to mention inconsistencies in the quality, look and feel of translated content.

Satellite operations in overseas markets are typically staffed by sales and marketing people, who often lack the capacity, project management or linguistic skills to keep on top of regulatory content translations.

Even in Europe, an established region for understanding and managing regulatory requirements including certified local translations, the demands are so substantial and in such a constant state of flux, that dedicated personnel, experience and skills are needed to maintain compliance.

There are currently 24 languages to provide for, for the EU’s centralised authorisation procedure. Broadening out to include non-EU countries increases Europe’s translation burden to 30-plus languages. Add in Asia, Africa and Latin America, and the translation requirement grows even further.

The tools and skills needed for smart translation

As firms’ global ambitions grow, so their translation requirements multiply, and the case builds for a holistic approach to tracking evolving international regulatory requirements, and for delivering timely and accurate local translations for each market.

This requires a centralised, systematic approach to the coordination and execution of translation projects, offering scope for greater consistency, cost-efficiency and a clear line of sight across workloads and upcoming demands.

Managed regulatory translation service providers who specialise in life sciences content will have pools of resources, skills and experience that companies can count on and become a huge asset as a result. They will have found ways to accelerate delivery – for example by harnessing translation memory technology: which can automatically draw on specialist, agreed phrasing and terminology in the target language, from previous use cases. The longer an organisation continues to use the same provider to manage translations, the faster the output.

In addition to including each firm’s specific terminology and references, translation memories also benefit from regional and country-specific templates and glossaries of standard terms and phrasing - including EMA’s Quality Review of Documents (QRD) human product information templates, for instance.

Although next-generation automation using artificial intelligence (AI) are still evolving, in time such capabilities will add significant value. Increased automation will decrease cost and turnaround times even further.  A good translation partner will have this kind of technology built into its technology automation roadmap, for when tools are deemed mature and robust enough to meet the acutely sensitive need for quality and accuracy in the translation of life sciences/medical content.

The business benefits of smart translation

Firms should try and change how they perceive regulatory translation activities. When done well they can offer many business benefits – access to new revenue streams, keeping unnecessary risks to product supply at bay - and are certainly not an unwelcome cost burden.

Assuming a more strategic position on regulatory translations, and developing a robust, centralised global capability, offers the best chance of keeping control over spiralling costs and requirements. This should include continuous, coordinated access to the right expertise, quality consistency and capacity, plus the ability to harness the benefits of technology-enabled automation as appropriate.

About the author

Nancy Pollini is director of strategic accounts for language services at AMPLEXOR Life Sciences.