Three Real Printing Boundaries for Drug Packaging Materials in Joint Review and Registration: Registration Number / Status Identifiers A and I / Batch Traceability — What Should a Printing House Check First Upon Receiving a Pharmaceutical Packaging Order?

In March 2026, a customer who produces oral solid dosage form bottling lines sent us a batch of bottle label designs. Their first words were: “Just print that number at the top as it is.”

There is a string on the design artwork consisting of a series of digits in a format similar to F20250000000. The client said this is the "Pharmaceutical Packaging Material Registration Number."

We didn’t dare start the machine directly, because another number was printed on the same artwork and on the same line—the medicine’s own approval number, in the “National Drug Approval No. H…” format. The two sets of numbers were very close together and looked similar, but they referred to entirely different things.

More importantly, in the screenshot of the registration platform sent by the customer, the status indicator following the registration number is marked as I.

This article focuses on this issue. For pharmaceutical packaging materials, the printer's real job is not simply to “print the numbers,” but to verify the correspondence of all three points before starting the press.

First category of boundaries: the registration number is not the approval number, and the two numbers must not be printed together

First, clarify the regulatory background, because many printing plants confuse these two systems.

Before 2017, pharmaceutical excipients and packaging materials in direct contact with pharmaceuticals (collectively referred to as “pharmaceutical packaging materials”) were subject to separate approval: pharmaceutical packaging material manufacturers had to apply on their own and obtain an approval number before they could sell to pharmaceutical manufacturers. Notice No. 155 of 2016 and the relevant State Council document of 2017 changed this system—separate approval was abolished and replaced with a registration system, followed by “associated review” with pharmaceutical registration applications.

After the changes, the relationship between the two sets of numbers is as follows:

NumberOwnerHolderMeaning When Printed on PackagingDrug Approval NumberDrugDrug Marketing Authorization HolderThis drug has been approved for marketingDrug Packaging Material Registration NumberPackaging materials and containersDrug packaging material registrantThis packaging material has completed registration and is undergoing or has participated in an associated review

The key is that the registration number is issued by the registration platform to the packaging materials enterprise, which then uses it to negotiate with pharmaceutical companies; on the pharmaceutical side, to use this packaging material, the registration number must be entered in the application.

Therefore, the most common mistake printers make here is to print the registration number on the drug instructions or the front of the medicine box, alongside the drug approval number. It looks neat from a layout perspective, but the meaning is confusing—consumers looking at the box may mistake it for the drug’s approval number.

Our factory’s practice is as follows: the drug approval number and registration certificate number are printed in the designated areas of the drug packaging in accordance with applicable regulations; the pharmaceutical packaging material registration number is printed on the packaging material itself or in the signature area of the package insert inside the medicine box, labeled “Packaging Material Registration Number”, and verified against the customer-provided registration form to ensure that the registration number, product name, specifications, and registration status all correspond to the same row.

The second type of boundary: Status identifiers A and I, with the difference being whether they are “usable”

The registration platform has a status indicator for each registration number, which is clearly stated in the public information:

A —— Has passed technical review, or has completed review together with the associated formulation.

I —— The technical review was not approved, or no association has yet been established.

The practical meanings of these two letters differ substantially. The I status means that the registration action itself has been completed (the completeness review of the information has been passed), but the association between this packaging component and a specific pharmaceutical formulation has not yet been established, or the technical review was not passed.

In practice, printing companies typically encounter two situations:

Scenario 1: The customer has a registration number for status A on hand.This is a normal production number; the printing plant simply prints using the number provided by the customer, but the number, product name, and specifications must be checked to ensure they match. In some cases, customers inadvertently carry over the number from the previous product when copying and pasting from the registration form.

Scenario 2: The customer has a registration number in status I in hand. At this point, it is not enough to look at the number alone; you must ask: “Which formulation is this registration number associated with?” If the customer is promoting multiple specifications and packaging formats simultaneously, a number in status I may be a transitional status used while the registration has been completed but the associated records are still being established. This is not uncommon in the industry, but the responsibility must be clearly specified.

Our factory’s practice is to include a sentence in the quotation and email:

“The packaging material registration number and its associated status shall be determined based on the registration platform information provided by Party A. We assume no responsibility for the association between the registration number and the formulation or for the review results.”

This statement may look like blame-shifting, but it actually distinguishes two things: the printer's responsibility is to “accurately print the number you provide, in the correct position, without making it illegible,” not to “determine whether that number can be used.” The latter is the legal obligation of the drug marketing authorization holder.

Another detail that printing plants should be aware of is that the registration number follows the packaging material specifications. For the same packaging material, changes to the material, thickness, or production address may all require updates to the registration information. Therefore, the “number from last month” provided to the printing plant may not necessarily be the number that can be used for this batch. Verify the registration number for each order; do not reuse the number from the previous batch.

The third type of boundary: where the registration number is printed determines where the traceability chain breaks

The third boundary is pure printing, which is also the part truly within the printer's control.

The markings on pharmaceutical packaging actually serve a traceability function—ensuring that, if something goes wrong, the affected batch can be recalled from the market. The registration number is an anchor point in this traceability chain.

We received an order for an oral solid drug packaged in bottles, with the registration number and batch number printed on the bottle labels. However, the shipment was rejected during inspection because the customer had applied the labels themselves, and the batch number on the bottle caps did not match the batch number on the labels—the two labels came from separate production lines, with no synchronization between them.

This issue is not directly related to the printing plant, but the customer will come to us because “you printed the labels.” Therefore, our approach is to clarify three matters in advance:

1. Which carrier should the registration number be printed on? Bottle labels, package inserts, boxes, and outer cartons have very different requirements for abrasion resistance, water resistance, and legibility. Bottle labels are repeatedly handled and rubbed by patients, whereas outer cartons must withstand transportation and stacking in warehouses. Using the same paper for all four carriers is a common shortcut and also a common source of accidents.

2. How should the font size and contrast be determined? Pharmaceutical packaging is subject to statutory requirements for font size. Although the registration number is generally not included in the mandatory font-size list, it is traceability information and must be clear enough to be read reliably by a barcode scanner. Our approach is to use the smallest legible font size in bold for the registration number and batch number, while ensuring sufficient contrast between the paper surface and the ink, and avoiding placement on dark backgrounds or solid color blocks.

3. Printed on the bottle or on the label? Printing directly on the bottle means the traceability information stays with the container and cannot be separated by relabeling; however, this places requirements on surface treatment and adhesion. Printing on the label allows batches to be managed independently, but once the label and bottle are mismatched, they can never be correctly matched.

We will add a line to the process validation form: “Traceability information carrier method: direct printing / labeling; batch number printing location and responsible person: to be designated by Party A.”

Incidentally, drug packaging registration documentation must include stability studies and safety compatibility studies. This means that any change to the packaging material, composition, or supplier must theoretically undergo a change assessment—which directly affects the printer’s printing suitability judgment. For example, if a customer switches from conventional bottle material to a new material, the surface energy may change, and ink adhesion may change accordingly. Such changes must not be discovered only after a trial print has failed; the question “Has the material changed?” should be asked in advance.

Three Pre-Print Questions for Pharmaceutical Packaging Orders

Condense the three boundaries above into three sentences and use them to ask the following when receiving pharmaceutical packaging orders:

What to AskWhy1. What is the registration number, and is the status A or IConfirm whether this number can currently be used for this shipment, and also verify the variety name and specifications2. Which layout is used for the drug approval number, and on which medium is the registration number printedThe two numbers must not be placed together; since they are printed on different media, paper and printing processes must be selected separately3. Has the bottle material changed, and who is responsible for printing the traceability information?Material changes may affect printability; the person responsible for printing the batch number and registration number must be clearly identified

Once these three questions have been answered, what remains are the tasks we are truly familiar with: color, font size, paper stock, abrasion resistance, and resistance to alcohol wipes—pharmaceutical packaging has alcohol- and abrasion-resistance requirements that are an order of magnitude higher than ordinary food packaging, because patients may have alcohol or sweat on their hands, and the labels must withstand these conditions.

Further Reading

Read these articles together to understand the compliance boundaries for pharmaceutical and specialty-industry packaging:

ISO 15378 Quality Management System for Pharmaceutical Packaging Materials — Which documents do pharmaceutical companies review when auditing suppliers?

Three Types of Requirements for Sterile Medical Device Packaging—another compliance pathway for medical packaging.

Mandatory Requirements for Printing Medical Device Registration Numbers (3 Types) — How to handle the layout for the “other number” on medical products.

Real-Life Durability Tests for 3 Types of Digital Printing Post-Print Processes—Friction, tape, and alcohol rubbing: three essential tests for pharmaceutical labels.