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Managing Local Language Regulatory Submissions


The call to reduce market entry times for life-saving new drug therapies is becoming more urgent. What constitutes best practice in managing translations in today’s regulatory affairs environment? Nancy Pollini reports.

Few regulatory affairs heads would dispute the rising complexity of compliance and regulation in life sciences. Despite efforts to encourage consistency in international submissions, evolving priorities and variances in individual market demands are heaping the pressure on regulatory professionals. This also renders the job of translating regulatory content difficult and costly, because what works for one country or region cannot be assumed to apply in another. Requirements about which parts of a registration dossier require translation are often the subject of review.

Yet none of this must slow down the process of getting products to market. The call to reduce market entry times for life-saving new drug therapies is becoming louder and more urgent. Given such challenges, what constitutes best practice in managing translations in today’s regulatory affairs environment? 

Preparing existing and new products for distribution in international markets is far from straightforward, especially in industries as stringently regulated as life sciences. Despite global efforts to harmonize standards and controls, by aligning regulatory requirements, terminology and processes, significant differences remain from one region and one country to another. This is as true in established western markets as in emerging economies.

All of 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 have serious ramifications – ranging from omissions or errors that delay market access, to more discrete but critical mistakes that could lead to product recall, or worse, 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.

Plans for expansion into lucrative new markets can add up to a considerable undertaking from a regulatory translation perspective. China, which has become a major source of strategic focus for any overseas exporter of goods because of its vast and fast-growing market potential, currently requires that all product information and clinical data included in drug registration dossiers are translated into Chinese. This adds up to a considerable volume of words to translate which leads to spiralling costs and strain on inherently aggressive submission timelines.

The translation workloads involved for China alone are immense – AMPLEXOR, for example, has processed registration dossiers running to more than 2 million words for clients keen to gain access to mainland China. And once products are on the international conveyor belt, the clock ticks quickly. It is not unusual to be expected to turn around certified translations for such volumes within as short a timeframe as two to three months. So it’s essential that companies have a robust plan for managing this.

Consistency is critical

Before now, it has been common for life sciences firms to devolve responsibility for individual market translations of registration documents, as well as patient-facing labels and product information leaflets, to local teams who are expected to manage requirements with the help of local translation agencies. Yet this approach has brought with it a number of challenges, and with them a risk of soaring expense and potential delay to market access - not to mention variances in the quality, look and feel of translated content, inevitable when a range of different organizations are doing the translation work.

For one thing, satellite operations in overseas markets are typically staffed by sales and marketing people. Although tasked with growing the business, they are unlikely to have the capacity, project management or linguistic skills to keep on top of regulatory content translations. And, with other pressing commercial demands consuming their time, they may not be able to continuously monitor evolving regulatory requirements and their bearing on translated content and  for the local market.

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. EU membership isn’t necessarily set in stone; it isn’t all that long since Croatia joined; and now the UK is leaving, which in time could have implications for the dominance of the English language in regulatory administration, once the European Medicines Agency has reoriented itself on the mainland.  

As it is, there are 24 languages to provide for, for the EU’s centralized authorization procedure. Broadening out to include non-EU countries increases the region’s translation burden to 30-plus languages. Add in Asia, Africa and Latin America, and the translation requirement swells further – whether it’s accounting for a country’s particular take on French or Portuguese, or the local dialect which needs to be reflected in patient-facing materials. Where the workload also includes clinical activities, additional considerations for translations will need to be applied to where studies are taking place.

The life sciences industry is very volatile too, characterized by high levels of mergers, acquisitions, spin-offs and start-up activity as companies strive to get innovative new therapies out to market quickly and get a jump on the competition. With so much at stake, no company can afford to see its products languishing in limbo because the local registration process has stalled.

Keeping control of quality & workloads

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

A centralized, systematic approach to the coordination and execution of translation projects offers scope for greater consistency, cost-efficiency and a clear line of sight across workloads and upcoming demands. It also paves the way for additional efficiencies – such as those enabled through the strategic application of technology for helping to process translations.

Tools of the trade

Managed regulatory translation service providers who specialize in life sciences content will have pools of resources, skills and experience that companies can count on and draw on as needed.

They will also 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 organization continues to use the same provider to manage translations, the faster the output. Over five years, one major life sciences brand saw the rate of leverage (acceleration of output using repeated content) grow from 20 to 60 per cent on Chinese submission translations. Apply this kind of efficiency to dossiers running to 2 million words, and it’s easy to see how local registration timescales and translation costs can be reduced so that tight deadlines of 2-3 months can be met with a small, dedicated expert team.

Translation memories belong to the client and are specific to each company, to ensure complete data security and privacy. But, as well as including each firm’s specific terminology and references (eg content from previous translations), they 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. Specialist translation tools are becoming more and more sophisticated all the time, now even including automated format compliance checks to ensure authorities’ respective standards are met for international submissions. All of which helps to expedite the delivery of high-quality output to ensure prompt, smooth authorisation.

Although next-generation automation using artificial intelligence and machine learning are still evolving, in due course 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. Any company wishing to maximise the efficiencies of translation services should be open to using these kinds of techniques in future.

Prioritizing translation as a contributor to growth

Rather than viewing regulatory translation activities as a necessary evil and unwelcome cost burden, it is worth considering that, managed effectively, these activities support timely access to new revenue streams - while keeping at bay unnecessary risks to product supply.

Assuming a more strategic position on regulatory translations, and developing a robust, centralized 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. Certainly, with soaring ambitions and mounting operational challenges, there is a broader decision to be made about where a company’s own resources are best concentrated.

About the author

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


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