Age-Friendly Drug Labels: The Real Boundaries of 3 Formats—Large Print, Simplified, and QR Code Electronic Versions: Which Requirement Should Printers Prioritize?

In April 2024, a long-standing client who produces traditional Chinese medicines sent us a stack of documents and said, “Our drug regulator has told us that we need to adapt the package insert for elderly users. Send us a quote.”

We asked, “Which version should we make?” He was taken aback for a moment and replied, “The one with slightly larger text.”

This misunderstanding can be expensive. In October 2023, the National Medical Products Administration released the Working Plan for Aging-Friendly and Accessible Reform of Drug Instructions, which offered three pilot approaches with vastly different workloads. Increasing the font size is the lightest option; another requires restructuring the entire drug instruction leaflet; the third requires adding a QR code and a supporting electronic drug instruction service, involving data platforms, filing, and coordination with printed versions.

We presented three options to this customer, and he ultimately chose the middle one. He later said, “Had I known it was this simple, I should have asked for clarification from the outset.”

Type 1: Large-text Version — Change Only the Font and Formatting, Without Altering Any Content

The large-format format is the easiest of the three options for the printing plant.

The original text of the plan is: Provide a paper drug instructions leaflet (large-print version). The content of the drug instructions leaflet (large-print version) is identical to that of the complete version, with only the font and formatting of certain items enlarged and printed in bold.

The phrase “identical content” gives the printing plant peace of mind—no reapproval, no changes to the layout logic, and no product-level verification required. It only concerns the layout and font size.

However, the issue most likely to cause the printing company to fail is not layout, but binding and dimensions.

A typical case from public reports involves a pharmaceutical company in Jiangsu that produced a large-print version of Xiaochaihu Granules. If the package insert dimensions changed significantly, the company might have needed to re-customize the molds for its automated production line, and the folded package insert might no longer fit inside the medicine box. The company ultimately adopted the following solution: keeping the package insert dimensions unchanged, changing the font size from No. 8 to No. 4, and printing on both sides.

These three sentences are principles every printing company should remember:

ConstraintWhy It OccursWhat the Printer Should Confirm in AdvanceDimensions remain unchangedThe package insert is folded and inserted into the medicine box, so changing its dimensions may mean it no longer fits; any change also requires adjustment to the folding die on the production lineThe maximum unfolded dimensions of the package insert that can fit inside the medicine boxFont size reduced from 8 pt to 4 ptThe amount of information on the page remains unchanged, so increasing the font size necessarily requires reducing the line spacing and white spaceHas the customer already reworked the line spacing in the layout draft?Front and Back PrintingThe number of pages must be doubled to accommodate the enlarged font sizeAvailable space inside the box, fold direction, and whether the instruction manual has a fold-over registration mark

Front-and-back printing also creates a folding task: a single A5 sheet folded in half to A6 as an instruction leaflet must remain readable on both sides, so the fold line must avoid pressing over important information, such as “Dosage and Administration” or “Adverse Reactions.” If the sheet is folded in the wrong direction, the first page the customer sees may not even display the drug name, rendering the entire leaflet useless.

The cost structure of a large-format version is very clear: there is no layout design fee, only the printing cost and a small revision fee.If a customer only needs the large-format version, the printer’s job is basically to “print according to the layout supplied by the customer, paying attention to the fold direction and the box dimensions.”

Type 2: Simplified Version — Original Content Quoted, but the Layout Is Redone

The simplified version is the most demanding on the printer among the three options.

Original proposal: Provide paper-based drug instructions (simplified version) and electronic drug instructions (complete version). The paper drug instructions (simplified version) should quote selected sections of the electronic drug instructions (complete version) verbatim, with only adjustments to the font and formatting, without modifying the content.

The key lies in the four words “verbatim quotation.” This does not mean asking a certified company to rewrite its own manual; instead, select several items from the complete version, copy them word for word, and adjust only the font and formatting.

Public reports include a specific example: etoricoxib tablets used to treat arthritis and primary dysmenorrhea. The simplified redesign removed 17 explanatory sections while retaining 9 key details, including the medicine name, ingredients, properties, specifications, and contraindications.

Note the claim that “17 items were removed”—removed items do not disappear from the complete version; they must still be available in the electronic version. The simplified version and the electronic version form a pair and are not the same thing.

The printer’s role on this journey is:

• Layout rearrangement——When there are fewer items and larger type sizes, the original amount of information no longer fits on one page, so the column widths, line spacing, and margins must be redesigned;
• The project order remains fixed—the order of the items in the simplified version must match that of the full version so that clients and pharmacists can compare them side by side;
• Consistency check against the electronic version——This is where problems most often occur, because the printer uses the paper version while the filed version is electronic. Any discrepancy between the two creates an issue.

Why has this approach become the mainstream option in the pilot program? A set of figures makes the answer clear. The pilot data from Guangdong shows that 258 drugs were included in the pilot, 117 completed filing, and 60 have already entered the market. Among the selected approaches, 148 chose Option 3, which combines the simplified version with the electronic version; 109 chose Option 2, which combines the full version with the electronic version; and only 1 chose Option 1, the large-print version.

Why is the simplified version the most popular? Because it solves two problems at once: it makes the text easier for older adults to read and keeps the paper instruction booklet from becoming too thick. When a pharmaceutical company representative explained why they had selected Option 3, they gave a very practical reason: the simplified medicine instructions are better suited to the packaging equipment, shortening the lead time for accessories while also reducing paper consumption and the frequency with which the printed instruction booklets need to be updated.

For printing companies, these three benefits mean the following: the boxes fit inside the bags more easily, production scheduling runs more smoothly, and the business is less affected by fluctuations in paper prices. The advantage of reducing paper usage is particularly valuable in years when paper prices and specifications fluctuate frequently, as it provides licensed companies with a tangible cost benefit.

Type 3: QR Code Digital Version—Printing Is the Printer’s Responsibility, While Data Management Is Someone Else’s

The third option may appear to be the most technical, but in reality it requires the least work from the printing plant.

The original proposal: Provide a complete paper package insert and a complete electronic package insert.The proposal also encourages holders to provide audio narration of package inserts and labels, as well as information in Braille.

The user-facing format is now highly mature: scan a QR code to open the electronic instructions, with adjustable font size, audio narration, and downloads. One report documented a 66-year-old diabetes patient scanning the QR code on a medicine box with a mobile phone under a pharmacist’s guidance. After selecting the “font size” button, the largest text was as large as a peanut, and tapping the small speaker icon on the right played an audio narration of the dosage and directions for use.

The printing plant has a very clear responsibility at this stage:

What the printer handlesWhat the printer does not handlePrint a QR code on the medicine box, following scanning specifications for size, quiet zone, and error correction levelWebpage, font, and voice features of the electronic instructionsEnsure that the QR code is printed on the medicine box in a position that avoids creases and interference from reflective materialsData storage and version management behind the QR codeConfirm with the customer that the instruction manual version in the QR code matches the printed versionRegistration process

The drug regulatory authorities of each province have established dedicated service platforms for this purpose. Shaanxi developed a “Digital Drug Instructions Service Platform” that companies can use free of charge. It enables them to simplify, organize, and supplement package insert content as required, then generate QR codes for filing and printing on packaging and paper package inserts. Hunan upgraded its drug registration supervision system by adding functions for uploading electronic package inserts and generating QR codes, while also providing companies with a free data storage platform.

Therefore, the most important thing for the printing plant to focus on is this: The QR code printed on the medicine box must not be trapped beneath a crease, obscured by an overly contrasting varnish, or placed in an area that may come into contact with the liquid medicine.

The printing parameters for the QR code itself have clear specifications: module size, error correction level, and quiet zone must all comply with the standards for scanning devices. We covered these in detail in another article, so we will not repeat them here.

Comparison of Three Options: Where the Printer’s Work and Costs Lie

When a customer says, “We are making our packaging senior-friendly,” the printer should respond with these three statements:

MethodPrinter’s WorkCost LevelMain Risks1 · Large-Type VersionPrinted according to the layout artwork; pay attention to the folding direction and internal box dimensions.Low; mainly printing costsChanging the dimensions requires modifying the tooling, while the fold may interfere with key information.II · Simplified Version + Electronic VersionLayout reformatting, multi-page printing, QR code printing, and consistency verification with the electronic versionMedium, including layout fees and QR code productionThe printed version and electronic version are inconsistent, or the box cannot accommodate the contents3 · Full version + digital versionPrint the full version of the manual + print a QR codeLow–medium, one less page-layout rearrangement than Method 2The QR code placement and paper manual still result in a thick document

There is a counterintuitive point in comparing Method 2 and Method 3: from the printer’s perspective, the “simplified version + electronic version” (Method 2) involves more work than the “complete version + electronic version” (Method 3), because the simplified version must be reformatted and aligned item by item with the electronic version. However, when considering the overall costs of certified companies, the simplified version is actually more economical because it saves both paper and space inside the box.

This is why a printing company should not choose the solution on the customer's behalf; it should only clearly report the workload required on the printing side for each of the three options. The printer does not have the drug regulator's guidance, the customer's packaging box format constraints, or the platform solution for the electronic instructions leaflet.

Three Questions Every Printer Should Be Asked on the Spot

Our factory always asks three questions when taking on this type of work:

1. Which of the three options have you selected?—If you cannot ask, have the client consult the drug regulatory authority or check the pilot list. In 2026, the National Medical Products Administration had already published the eighth batch of the pilot list, and the client’s product is most likely included.
2. “How many pages of instructions can fit inside the medicine box? Will the leaflet be folded along the long edge or the short edge?”—Answering this question can prevent an entire round of rework.
3. “When will the version of the electronic manual linked to the QR code be frozen, and who will be responsible for aligning the printed and electronic versions?”—Version inconsistency is the most common implementation failure in this type of project.

Looking back at that client, they ultimately chose the simplified version for a simple reason: their medicine boxes could not accommodate a thick package insert, so they used to fold the insert into thirds and tuck it inside; however, it came apart as soon as older users unfolded it. After switching to the simplified version, the insert was folded into halves, the text was larger, and there was enough space inside the box.

This issue ultimately does not appear in the instructions; it is expressed through the box format—at the printing stage, age-friendly modification often becomes a question of internal box space and the direction of the folding panels.

Further Reading

These articles belong to the same series as this article:

• Five Types of Nonconforming Barcode EAN-13 Printing Data—QR codes and barcodes on pharmaceutical boxes follow the same parameter specifications
• Printing the Drug Packaging Material Joint Review Registration Number: The Real Boundaries of 3 Types—Another type of number that must be printed correctly on pharmaceutical packaging materials
• Cosmetic Packaging NMPA Registration Number / Filing Number Printing: 4-Type Layout Boundaries—How to Determine Font Size and Contrast According to Industry Consensus
• Four Categories of Mandatory National Standards for Pharmaceutical Packaging—package inserts are the most complex category among them
• 5 Essential Sampling Contract Clauses to Review Before Placing a Gift Box Order—How to Define Acceptance Requirements for Revised Packaging Projects