Best Practices Review – Labeling of Investigational Medicinal Products in International Clinical Trials

Regulatory Challenges and Multilingual Solutions
May 31, 2016

As clinical trials become increasingly international in nature, pharmaceutical companies must anticipate multicultural and multilingual contingencies in all aspects of clinical study planning. This is especially the case for the labeling of Investigational Medicinal Products (IMPs) because of complex linguistic and regulatory issues associated with them.

This Best Practices Review from LUZ explains the difficulties and potential missteps faced by trial sponsors who must create IMP labeling for regulatory approval in foreign countries. Simple translation of label content is not enough. In order to avoid rejections by regulatory authorities, sponsors must consider regional and national differences in IMP-specific labeling requirements that affect content as well as format of the labels.

Partnering with a Language Services Provider (LSP) that has expertise in conducting reviews of the regulatory landscape in foreign countries is a key success factor. The Review concludes by highlighting the fundamental steps that an LSP must take to conduct effective reviews of regulatory requirements in each trial country.

Read this Review to:

  • Understand how requirements for IMP label content and format may differ in different countries
  • Gain insights into the approval process for IMP labeling used in international clinical trials
  • Identify what experience and value-added services to look for when selecting an LSP to translate IMP labels

About LUZ, Inc.

Founded in 1994, LUZ is the world’s leading language translation company for life sciences. With a special focus on medical device, pharmaceutical, biotechnology, and clinical research organizations, we simplify and expedite entry into global markets by delivering accurate and compliant translations of product and regulatory documentation. LUZ is a certified women- and minority-owned business and maintains quality certifications to ISO 9001, ISO 13485, and EN 15038 standards.

Press Contact

Waldemar Frank
VP, Product Management & Marketing
415.981.5890 ext. 138
waldemar.frank@luz.com