How to Create Compliant Clinical Trial Labels for Multi-Country Clinical Trials

Clinical trials come with tremendous responsibility to meet the demands of the regulatory bodies, sponsors, and end-users. As the number of clinical trials keeps rising, the pressure to succeed amidst an increasing cost, new regulations, and cut-throat competition makes clinical trial labels a priority area in your product development.

Notably, clinical trials are becoming multilingual by the day, involving several study centers and several different countries. Consequently, for you to meet both international and local standards, your medical products must have multilingual labels. This guide provides tips on how to label your clinical trial packages for global testing centers and markets.

Key Statistics on Clinical Trials to Ponder

• Statistics from the US National Library of Medicine reveal there were a total of 362,524 clinical trials in 2020
• A new study from the MIT Sloan School of Management reveals about 14 percent of drugs in clinical trials are ultimately approved by the FDA
• More than 18,000 clinical trials are actively recruiting patients in the US.
• The FDA approved 309 new drugs between 2011 and in 2018, translating to 38 per year on average.

Tips for Multilingual Clinical Trial Labels

Multilingual labeling is crucial if you are looking to test and later sell your products in other countries. When performing clinical trials for drug-related treatments in foreign countries, all product labels must be translated with strict adherence to local regulations.

The following are some of the tips for translating product labels for international use:

Create a Region-Specific Drug Label

Research the labeling requirements of a specific region and develop region-specific trial labels with matching regulatory requirements using a dominant language for those regions. For example, you can develop a source label that incorporates regulations of all NAFTA countries. Afterward, localize and translate them into the dominant languages of each region, including Spanish, French, English, depending on the member countries.

Leverage Expanded-Content Label To Meet Multilingual Labeling Requirements

If you are developing medical products to be tested and marketed in several different countries, you can meet multiple language labeling requirements with the help of the Expanded-Content Label (ECL) system. With ECL, you won't need to make different labels for each country, but only one multilingual label for all of them.

Leverage Multilingual Booklet Labels

Another great option is to integrate several languages into a single product. You can achieve these using booklet labels, which are now available up to 113 pages. This offers an all-purpose solution for all countries to use where your product has a presence. Booklet labels can encompass both seal adhesive labels and leaflets. Due to their large volumes, these booklets can comfortably accommodate all languages in a clear structure and readable font size.

Pro tip: In 2013, the International Society for Pharmaceutical Engineering published a new guide for standardizing the use of booklet labels in global clinical trials. The primary goal of this standardization was to establish a uniform design and an international structure for booklet labels across all markets.

Overview of the Different Types of Standards for Clinical Trial Labels in Different Countries

There are various regulatory requirements to meet when creating compliant clinical trial labels depending on the region and specific country. Some of the major international regulatory standards for clinical trial labels by country/ region include:

The European Union (EU)

For EU member countries, the labeling requirements should be in accordance with EU requirements. Label content requirements are specified in Annex 13 of the European Commission, whereas structure and other elements such as layout, font size, and symbols are defined in the Guideline on Readability.

Notably, before a drug or medical device is sold within the EU, it is mandatory that all accompanying documents be translated into at least one of its 24 official languages. You should also keep in mind that individual countries within the EU have additional regulations that drug and medical device manufacturers must adhere to.

Requirements for EU Clinical Trial Labels

Some of the labeling requirements needed by EC include:

• All contact details of the sponsor, investigator, or contract research centers, such as name, address, and telephone number, must be provided.
• If you are testing a drug, you must provide relevant details. For example, pharmaceutical dosage form, the number of dosage units, route of administration, the number of dosage units. If you are using open trials, you must provide the name/identifier and strength/potency
• Provide relevant batch and/or code number that helps to identify the contents and packaging operation
• You should also provide the trial reference code that allows identification of the site, trial, sponsor, or investigator and sponsor
• Include the visit number and trial subject identification or treatment number
• Provide directions for use and a reference such as a leaflet that guides the person administering the product.
• You should also include the "For clinical trial use only" slogan or wording;
• Provide the storage conditions on the labels
• Indicate the period of use, including the use-by date, expiry date, or re-test date as applicable. This information should be in month/year format to avoid any ambiguity.
• Indicate the "keep out of reach of children" wording. However, this is unless the product will be used by subjects in a non-home environment.

US Food and Drug Administration Requirements

Clinical trials in the US have to meet the Code of Federal Regulations requirements, commonly referred to as Title 21 of the CFR. Part 312 section 312.6 of the code of regulations deals with labeling an investigational new drug.

Requirements for US Clinical Trial Labels

The following are some of its primary requirements:

• The package of a new drug under trial intended for a human must come with a label that bears the statement "Caution: New Drug - Limited by Federal (or the United States) law to investigational use".
• The labeling of a drug or medical device under trial must not provide false or misleading statements. It should not convey any messaging that could imply the investigational new drug is safe or effective for use.
• Label the immediate container with the following elements: protocol/clinical trial number, name of the product, dosage/ concentration and strength, formulation, quantity per container, lot/batch number, expiration/ retest date, storage requirements, a CFR statement(New Drug—Limited by Federal (or US) law to investigational use), name and address of the sponsor.
• The following are other optional information to include on the label if the space will allow: investigator name, patient number, special warning
• For label text on product containers, the FDA requires that you use font size 8 or larger. Ideally, you should also make the drug name and strength as prominent as possible.
• Label the outer cartons of the investigational drugs with the following elements: product name, dosage strength/concentration, lot/batch number, formulation, storage requirements, quantity, protocol number
• Display the primary label such as peel-off labels in English only if you are conducting the studies in the USA.
• Translate the peel-off labels appropriately if you are conducting trials in non-English-speaking countries. You should also standardize the format and content of labels provided in international languages.
• Incorporate a barcode on all investigational drug containers to help identify the product if scanned.
• Label investigational drugs are to be used by a single patient to differentiate them from the main study supplies.

Get Professional Help With Clinical Trial Labels

Labeling is an essential and integral part of the approval of a medicinal product. Notably, clinical trial labels are increasingly becoming multifunctional tools that help convey crucial information in different languages in diverse locations where trials are being conducted. Each country/ region typically provides regulatory guidance for investigational drug labeling, packaging, and nomenclature. You must comply with each requirement to avoid delays and achieve regulatory approval. We develop innovative label solutions for your products. Contact us today to learn more.