Navigate Global Regulatory Hurdles
with Expert Translation and Localization

Countries and even regions each have their pre- and post-approval regulations, procedures, ethical requirements, clinical protocols, and required languages, despite harmonization efforts. That makes the process of starting global trials and getting drugs, devices, combination products, supplements, and cosmetics approved for market complicated – to say the least.

Navigating regulatory hurdles starts with an efficient framework that accommodates linguistic, cultural, and regulatory differences for submissions and includes the following considerations:

International Standards

An effective regulatory strategy starts with following key international standards for life sciences and cosmetics companies. These standards set the minimum acceptable levels for quality assurance, safety, efficacy, accuracy, etc. Once your company complies with the standards, you can more easily incorporate the nuances of each country and region’s regulatory requirements, which often build on international standards, and add components that are specific to the needs of that regulatory authority. Having a local representative also helps you to understand the processes, terminology, language, and culture that are important to submitting a regulatory package for approval.

Some of the key standards for life sciences companies include, but are not limited to, the following:

ISO 9001 and ISO 9002:

Most medical device and biotech companies strive for these certifications, partly because doing so facilitates regulatory reviews and helps to ensure that processes are documented and followed.

Good Clinical Practices (FDA, ICH):

Clinical trials have stringent requirements for ethical conduct, data management, scientific quality, and informed consent to protect the rights, safety, and well-being of the patients in the trial and those who access the drug or device after approval. These standards document the key components of good clinical practices.

Good Manufacturing Practices (WHO, ISO):

Drugs, medical devices, cosmetics, and other products must maintain a Batch Manufacturing Record (BMR) or Device History Record (DHR) and track them throughout their lifecycle. Following these standards helps ensure consistent quality, consistent and repeatable processes

CE mark (EU):

This certification indicates that a product complies with safety, health, and environmental protection standards for the EU. Medical devices and other regulated products must have a CE mark in order to be sold in the EU.

ISO 13485:2016/FDA QMSR:

These standards are specific to the quality management of medical devices and related products.

ISO 22716:2007:

Because cosmetics are worn on the skin, they follow similar requirements to drugs and devices in terms of safety. This standard is specific to quality management along the entire supply chain for manufacturing cosmetics.

EU Medical Device Regulation (MDR):

Recent changes to this standard have huge implications for medical device companies globally and fundamentally change the landscape for device approval and market entry in the EU. For example, the current local language requirement means you must translate into 24 EU languages prior to receiving approval.

This is not a comprehensive list, but these standards are fundamental to establishing a consistent framework for managing global regulatory filings in life sciences. Compliance with these standards demonstrates a commitment to quality and facilitates entry into new markets.

In addition, regulatory authorities typically require the submissions to be in the local language(s) and expect the content to meet linguistic, cultural, and compliance requirements. Patient information, in particular, needs to be hyper-localized and account for the appropriate medical terminology and cultural considerations.

Structured Content

Structured content is one of the most effective ways to manage content volume, shifting regulatory requirements, regional differences, and multilingual requirements.

With structured content, you can create modular, reusable components for each type of information in your regulatory filing, then recombine and customize those components to meet the needs of a particular regulatory authority.

By structuring the content as components, you can establish workflows to translate only the components that apply to a particular submission while ensuring consistency and version control in your source documentation. As regulations change, you can more easily manage those changes and only need to update the affected components, which simplifies compliance, maintenance, and traceability.

For localization and translation, teams can work on components as the source content is approved internally and can directly create locale-specific content in the local language while maintaining the relationship to the other source content. Localizing the content in batches, as each component is approved, streamlines the filing process and can speed up time to approval and market.

Data Collection and Reporting

Accurate, comprehensive data help demonstrate compliance with safety and efficacy requirements. With the trend toward digitization, many regulatory authorities have expanded their requirements for electronic data submission. Although regulations around the use of AI and machine learning are in the early stages, organizations must comply with data and patient privacy regulations, such as GPDR in the EU or HIPAA in the US.

This trend toward electronic submissions and record-keeping enables companies to collect and maintain accurate, easily auditable records and to ensure that the documentation meets the specific requirements of the local regulatory authority. With the assistance of AI analytics, companies can more quickly identify patterns, predict risks, and automate some of the review processes while managing larger volumes of data.

Electronic data collection and reporting also streamline the localization and translation process and make it easier to update as new information comes in.

Localization and Translation

Medical practices, knowledge, accessibility, and attitudes vary greatly globally. When asking patients to trust a new medical practice or to participate in a trial, you need to have a deep understanding of the local culture, linguistic preferences, and clinical practice so you can communicate effectively with both patients and medical staff.

Ethnographies can help you better understand the local population’s culture and preferences related to medical research and clinical practice. By asking carefully worded questions, you can identify potential barriers, colloquial terms, local customs, healthcare literacy, regional nuances, and other demographics and psychographics.

Local regulatory specialists work with localization experts and your internal teams to ensure that regulatory submissions comply with local regulations, incorporate cultural nuances, and are accessible to the region’s intended audience.

For patient-facing content, you may need to hyper-localize the content to accommodate cultural nuances, regional differences in terminology or practices, and educational levels. By doing so, you can ensure patient safety, comprehension, and compliance with the clinical protocols. In addition, such hyper-localization helps build trust and adoption of the new product or procedure.

Conclusion

Global regulatory teams need efficient frameworks to support the complexities of managing submissions and trials with varying requirements, cultures, and languages. However, the data gathered when working with diverse patient populations provides greater confidence in the safety and efficacy of a drug, medical device, or procedure.

By leveraging international standards, structured content, data analysis tools, and localization expertise, organizations can streamline their compliance with local regulations and speed time to approval and to market while also ensuring that their products and clinical protocols are accessible, safe, and efficacious for their patients wherever they live and work.

Would you like to discuss this with our life sciences experts? Contact us today to find out more.

References

CE Mark. European Commission. Accessed [October 2024]. https://single-market-economy.ec.europa.eu/single-market/ce-marking_en

General Data Protection Regulation (GDPR). GDPR.eu. Accessed [October 2024]. https://gdpr.eu/compliance/

Good Clinical Practices. U.S. Food and Drug Administration. Accessed [October 2024]. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/good-clinical-practice

Good Manufacturing Practices. World Health Organization. Accessed [October 2024]. https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/norms-and-standards/gmp#:~:text=Good%20Manufacturing%20Practices%20(GMP%2C%20also,required%20by%20the%20product%20specification

Hanes, Carrie. “Structured Content.” Sanity. Accessed [October 2024]. https://www.sanity.io/structured-content

Health Insurance Portability and Accountability Act (HIPAA). U.S. Department of Health and Human Services. Accessed [October 2024]. https://www.hhs.gov/hipaa/index.html

ISO 13485:2016. Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes. Accessed [October 2024]. https://www.iso.org/standard/59752.html

ISO 15223-1:2021. Medical Devices — Symbols to Be Used with Information to Be Supplied by the Manufacturer. Accessed [October 2024]. https://www.iso.org/standard/77326.html

ISO 22716:2007. Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices. Last reviewed in 2022. Accessed [October 2024]. https://www.iso.org/standard/36437.html

ISO 9001:2015. Quality Management Systems — Requirements. Accessed [October 2024]. https://www.iso.org/standard/62085.html

ISO 9002:2016. Quality Management Systems — Guidelines for the Application of ISO 9001:2015. Accessed [October 2024]. https://www.iso.org/standard/66204.html

International Good Clinical Practices, International Council of Harmonization E6(R3). Draft Guidelines. Accessed [October 2024]. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf

Life Sciences in Focus, Podcast Episode 5 with Toban Zolman, CEO of Kivo. Vistatec. Accessed [October 2024]. https://vistatec.com/life-sciences-in-focus-podcast-ep-05-toban-zolman-ceo-kivo/

Number of Clinical Trials by Year, Country, WHO Region, and Income Group. World Health Organization. Accessed [October 2024]. https://www.who.int/observatories/global-observatory-on-health-research-and-development/monitoring/number-of-clinical-trials-by-year-country-who-region-and-income-group

Quality Management System Regulation (QMSR). U.S. Food and Drug Administration. Accessed [October 2024]. https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked

The Intricate World of Regulatory Affairs, Life Sciences in Focus, Podcast Episode 3. Vistatec. Accessed [October 2024]. https://vistatec.com/the-intricate-world-of-regulatory-affairs-life-sciences-in-focus-podcast-episode-3/

Navigate Global Regulatory Hurdleswith Expert Translation and Localization