Life science organizations must be truly global in order to build a sustainable business/organization. A strategy focusing on one (or few) market(s) is difficult and inequitable. In order to succeed around the world, it is important to understand the regulatory requirements in localization. The continuously evolving regulations in pharmaceutical, biotech, clinical research and medical device industries require expertise to ensure you are meeting the linguistic requirements for each country/region. New regulations almost always mean a heavier volume of content to handle. While companies are often granted a grace period extending (depending on the directive), they must continuously plan how to address language compliance. As a leading life science translations organization, here’s what we’ve seen so far with the upcoming regulatory compliance changes and where organizations should go from here.
changes to life science translations are coming
Upcoming changes in life science communications and content around the world span several key areas, including:
EU
• Clinical Trial Regulations
• Medical Devices
• In Vitro Diagnostics
• European Medicines Agency (EMA)
• European Unified Patent Court (UPC)
• EudraVigilance
• EU Health Technology Assessments
• EU Identification of Medicinal Products (EU IDMP)
United States
• Electronic Records and Signatures
• FDA Medical Device Quality Management System Regulation
• HIPAA Privacy Rules
• Drug Supply Chain Security Act (DSCSA)
Mexico
• Official Mexican Standard NOM-241-SSA1-2021
Australia
• Therapeutic Goods Legislation Amendment
• Therapeutic Goods (Medical Devices)
Japan
• Revision of Japanese Medical Device QMS Requirements
India
• Medical Devices (Amendment) Rules, 2020
• Indian Personal Data Protection Bill 2019
China
• Medical Device Regulations Order No. 739
• China’s Medical Device Approval Process
In addition, a number of new legislations are still in their early stages of development. These range from life science-specific applications as well as applications that may have an impact on companies operating within the industry. For example, the EU Data Act will focus on data generated by devices connected to the Internet of Things, which may affect some medical devices.
As these new changes trickle into practice, companies must adapt the language in their content to reflect new standards and be prepared to translate their content in a way that’s also culturally relevant.
the challenges of achieving full language compliance
Life science organizations face no shortage of challenges when it comes to full language compliance. First and foremost, there’s the sheer number of new or exotic languages that must be included in the process. Word-for-word translations rarely do the job, as they don’t take into account any cultural differences in how we communicate.
There’s also the matter of unclear deadlines, which can often be more of a pain point than tight deadlines. The lack of visibility into what a piece of legislation means and when it will be enforced, coupled with an organization’s stringent internal affairs, can lead to additional complexities in rolling out new, compliant content.
Many companies are eager to get to market quickly, letting translations fall to the wayside. They’re a necessary component, but one that doesn’t get enough attention or forethought, particularly in going beyond word-for-word translations.
There’s also the fact that regulatory agencies don’t often share the ins and outs of the language requirements. Localization managers instead must rely on their peers or vendors and adapt their content in the best manner. And when regulations do take effect, the work doesn’t end there. For example, some of our partners are still grappling with certain provisions of Medical Device Regulation (MDR) even though it’s been officially enacted for over a year. Some of the above regulations will continue to have an effect well beyond their entry date.
how to prepare for new language compliance for life sciences
Non-compliance isn’t an option when new regulations evolve. Companies should start preparing as early as possible, even when entry dates and compliance enforcement are years away.
First and foremost, be informed about the coming legislation in each of the countries or regions in which you do business. For many life sciences organizations, business is increasingly being conducted across borders. For example, more clinical trials are happening remotely rather than have participants travel to clinical trial sites. This decentralization of clinical trials expands who can participate in programs and increases diversity – which may require language services that weren’t needed in a traditional setting.
Also, treating culturally accurate and relevant content as a priority instead of an afterthought will help organizations get ahead of the curve. Rather than scrambling to achieve minimal compliance before going to market, companies can instead make translations a thoughtful process that adds value and impact to a global audience.
At CQ fluency, we’re helping to shape better, stronger conversations between life sciences companies and the populations they serve. We provide culturally relevant translations that achieve all nuances of compliance while optimizing the end-user experience. Track changes in regulations with confidence, achieve tight deadlines for compliance, and create content that does the most good for the populations you serve.
Achieve confidence in language compliance for life sciences with CQ fluency – contact us today!