Among the myriad steps involved in pharmaceutical product development, clinical labeling and packaging stand out as critical components that need special attention. Clinical trials are typically the most expensive part of the already costly and years long pharmaceutical development process so the importance of well-designed clinical labeling and packaging cannot be understated. Mislabeled or improperly packaged clinical trial materials could lead to disastrous consequences, not only for the individuals involved in the trial but also for the credibility of the entire study.
Precise and robust packaging and labeling done in accordance with the clinical trial protocol is essential for accurate dosing, storage, stability and administration of the trial materials. This is especially important in double-blind studies where neither the participants nor the investigators know who is receiving the active treatment. Moreover, clear and informative packaging and labeling can enhance trial participant compliance and facilitate the monitoring of adverse reactions, ultimately contributing to the reliability of the trial results.
Clinical trial materials often require refrigeration or freezing. Special care must be taken to ensure the packaging and labeling can withstand these types of environments. Labels need to remain well affixed and integrous; the label printing must remain unaffected by cold or contact with moist conditions. Labels made with high tack adhesive and an overlaminate are good options in this instance. As clinical trial materials may be shipped to sites throughout the world, the packaging must be sufficiently sturdy to withstand the rigors of shipping.
Beyond the immediate impact on trial participants, effective clinical trial packaging and labeling are vital for regulatory compliance and market approval. Regulatory agencies such as the FDA, EMA and Health Canada have stringent requirements1,2,3 for the packaging and labeling of investigational drugs, ensuring that they meet necessary quality and safety standards. Failure to adhere to these regulations can result in delays in the approval process or even the rejection of a new drug application. Therefore, investing in high quality clinical packaging and labeling processes not only safeguards the well-being of trial participants but also paves the way for successful regulatory submissions and the eventual commercialization of the drug.
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20221205
- https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/annex-13-good-manufacturing-practices-guidelines-drugs-clinical-trials-0036.html