ecent decades have seen global trade borders open up to an unprecedented degree, which has made it more straightforward than ever for pharmaceutical and medical device companies to take their products to markets all over the world. But how can they do this efficiently and at speed while still adhering to strict regulatory requirements that vary from country to country, when registration dossiers requiring translation for each local authority could exceed two million words?

Expanding into and engaging with emerging markets means handling a more complex set of languages as target regions diversify to include Africa, Asia and Latin America. That’s in addition to the changing nature and scope of the EU. What specific challenges does this present for heads of regulatory affairs? What are the risks, and what does an end-to-end translation program look like for an international life sciences firm in 2019?

As the world continues to feel smaller and more accessible from an international trade perspective, major multinational life sciences companies are seizing the opportunity to expand their markets and spread their competitive risk by taking their products to new territories. From Brazil and other Latin American markets to Africa and Asia, emerging market opportunities present a wealth of business growth potential — as long as organizations can enter each country cost-efficiently, with speed and at low risk. This in turn means ensuring that registrations and other local documentation, including patient-facing materials, are precisely, consistently and accurately translated for each new market in line with the latest local requirements.

This is a considerable undertaking. 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 content included in product registration dossiers is translated into standard Simplified Chinese. The translation workloads involved for China alone are immense — our company has already processed dossiers running over two 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 these dossiers within as short a timeframe as two to three months. So it’s essential that companies have a robust plan for managing all of this.

Local language support isn’t always best

It has been common in the past for life sciences firms to devolve responsibility for individual market translations of registration documents, as well as patient-facing labels and information leaflets, to local teams, to manage with the help of local translation agencies. Yet this approach has brought with it a host of challenges, and with them a risk of soaring expense and delay — not to mention variances in the quality, look and feel of translated content, which are inevitable when different organizations are doing translation work from one country to the next.

“Ultimately, regulatory translation activities can be seen either as a cost and necessary evil, or as a gateway to new global market opportunities.”

The first critical issue to arise when translation is pushed out to in-country teams is that these satellite operations primarily comprise sales and marketing staff. Although tasked with expanding the business, these people ordinarily will not have the capacity or project management skills to organize and keep on top of regulatory content translations. The second is that, with other pressing commercial demands consuming their time, they are unlikely to be monitoring evolving regulatory requirements and their bearing on translated content and information formatting for the local market. So making in-country teams, including local affiliates, accountable for managing translations is likely to prove a risk as well as a false economy.

Growing complexity

Even in Europe, traditionally a more 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 set in stone. It hasn’t been long since Croatia joined, and now the UK is leaving, of course, which in time could have implications for the dominance of the English language in regulatory administration, once the European Medicines Agency (EMA) has reoriented itself on the mainland.

As it is, there are 24 languages to cover for the EU’s centralized authorization procedure. Broadening out to Europe as a whole, including Eastern Europe, increases the regional translation burden to 30 or more different languages. Add in Asia, Africa and Latin America, and the number of required translations swells further, whether that’s a country’s particular take on French or Portuguese, or the local dialect which needs to be reflected in patient-facing materials. When the translation workload also includes clinical activities, additional considerations will need to be applied to where studies are taking place.

Certainly, nothing is static. The life sciences industry is currently very volatile, characterized by high levels of mergers, acquisitions and spin-off startup activity as companies strive to get innovative new therapies out to market quickly and establish themselves ahead of the competition. With so much at stake, no company can afford to see its products languishing in limbo because local registration and marketing authorization have been put on hold.

The case for centralized translation

With companies’ growing global appetites, and a rapidly multiplying translation requirement, an organization’s best hope of keeping its growth strategy on track is to have a holistic, end-to-end approach and system for tracking evolving international regulatory requirements, and for delivering timely and accurate local translations for each target market.

All of this points to the merits of a centralized, systematic approach to the coordination and execution of translation projects. On the one hand, this will enable greater consistency, cost-efficiency and a clear line of sight across workloads and upcoming demands. On the other, it paves the way for additional efficiencies such as those enabled through the strategic application of technology for helping to process translations.

Managed regulatory translation service providers that specialize in life sciences content will have pools of resources, skills and experience that companies can count on and draw on as needed. Moreover, they will also have found ways to accelerate delivery, for example by harnessing translation memory (TM) technology. If you’re new to the industry, this is software that can automatically draw on specialist, agreed phrasing and terminology in the target language from previous use cases. In theory, the longer an organization continues to use the same provider to manage translations, and continues to build its own TMs for the service provider to draw from, the faster the output. Over a period of five years, one major life sciences brand saw the rate of leverage (acceleration of output using repeated terms and phrasing) grow from 20% to 60% on translations for Chinese submissions. Apply this kind of efficiency to dossiers running to two million words, and it’s easy to see how local registration time-scales and translation costs could be reduced so that tight deadlines of two or three months can be met with a small, dedicated expert team.

TMs 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 (such as excerpts from previous translations for the company), they benefit from regional and country-specific templates and glossaries of standard terms and phrasing, including EMA’s templates for the quality review of documents for human product information, for instance. Specialist tools are becoming more and more sophisticated all the time, too — now even including automated formatting checks to meet authorities’ respective standards for international submissions. All of this can help expedite the delivery of high-quality output to ensure prompt, smooth authorization.

Widespread, next-generation automation using artificial intelligence and machine learning for medical content is still some way off given the sensitivity of the content and the life-or-death requirement for accuracy. However, such capabilities are advancing all the time and, in due course, are likely to add significant value to automated translation opportunities for life sciences. Many translation partners have this kind of technology built into their technology automation roadmap, for use when tools are deemed mature and robust enough to meet the acutely sensitive needs of life sciences. Any company wishing to maximize the efficiencies of translation services should be open to using these kinds of techniques in future. Partnering with a translation company whose advice and services can be based on technology choice, rather than dictated by a proprietary software system, can help to maximize the options.

Treating translation as an enabler of global growth

Ultimately, regulatory translation activities can be seen either as a cost and necessary evil, or as a gateway to new global market opportunities. With so much at stake — timely access to new revenue streams vs. the risk of costly delays or worse (risk to patients) caused by registration hold-ups — it is well worth taking time to develop a strategic position on regulatory translations, and developing a robust, centralized global capability. In reality, quality assurance depends on having ready, uninterrupted access to the right expertise, consistency and capacity; reliable, technology-enabled automation; and confidence-inspiring certification. And without an end-to-end plan, this isn’t easy to achieve.

As the current decade matures, and as companies’ global ambitions expand to encompass substantial emerging markets, life sciences firms are likely to find that they already have too much on their plates to contemplate tracking, project-managing and quality-assuring international regulatory translations and submissions, despite their criticality. The business case for seeking qualified, coordinated worldwide help has never been more compelling.