7 Common Artwork Compliance Hurdles in Pharma

Packaging artwork might seem secondary to the medicine inside the pack. But clear, accurate and compliant artwork is central to patient safety and regulatory approval, and getting it right takes meticulous attention to detail and strict quality control.

The volume alone makes this hard. In 2025, generics made up 89% of all US prescriptions filled, which works out to roughly 4 billion generic prescriptions in a single year. Every one of those products carries labeling that has to match its approved content, in every market, on every pack size.

The rules are also shifting. The EU has just adopted its biggest overhaul of medicines law in two decades, and electronic product information (ePI) is moving from pilot to rollout.

This blog walks through the seven artwork compliance hurdles pharma teams face, and what it takes to clear each one.

Challenge 1: Navigating the Pre-Market Approval Hurdles

Pharmaceutical products need pre-market approval from regulators such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). That review covers the product labeling too, so manufacturers must submit their labeling and packaging artwork and get it approved before launch.

Pharma labels and patient information leaflets (PILs) are complex because they need to:

Carry the medicine's use, dosage, warnings, storage conditions, composition, side effects and adverse reactions.

Be formatted so that information is clear, legible and easy to understand.

Use visual aids such as diagrams or icons where they help, especially for patients with limited language proficiency.

On top of that, the artwork has to meet the local and international rules of every target market. Each market adds its own layer of mandatory text, symbols and layout conventions.

This is where checks need to happen before submission, not after.

Challenge 2: Managing the Cyle of Changes and Approvals

Artwork approval in pharma is iterative by nature. A single product may come in several dosage forms, strengths and pack sizes, and be sold in many countries with different language requirements. Without version control and a structured artwork process, the wrong version can reach the press.

Regulators also keep the labeling moving. The FDA regularly notifies sponsors of required safety labeling changes, and some arrive for an entire drug class at once. In 2025, for example, the FDA required updated warnings across GLP-1 medicines and asked for a more uniform presentation of risk information on all of their labels. Gabapentinoid sponsors received similar notification letters with new withdrawal-risk wording. Each of those changes ripples into the PIL, the carton and every other component that carries the text.

Minor changes that do not affect a product's safety or effectiveness can be made without prior approval, but they still have to be documented and reported in the annual report.

The cycle of change and re-approval causes the biggest delays when the first submission is not accurate or complete.

Challenge 3: Reducing the Cost of Delays and Inaccuracies

Delays caused by non-compliant artwork translate directly into lost revenue. Errors or inconsistencies that reach the market carry legal exposure, regulatory action and reputational damage, and missed regulatory deadlines can bring penalties on top.

A recent case shows how small the error can be. In October 2026, Prodose recalled 100,134 bottles of ValuHealth Extra Strength Pain Relief Acetaminophen. The outer carton was correct, but the inner bottle label identified the product as the PM formula. The FDA classed it as low risk, yet the entire lot still had to come off shelves. The failure was not in the content. It was a mismatch between two components that were each, on their own, "approved."

The stakes grow as pharma companies expand into more markets, including emerging ones. Each new market means translations and local adaptations, and each adaptation is another place for a mismatch to slip in.

Catching this kind of error means checking what was actually printed, not only what was approved.  

Challenge 4: Getting it Right First Time

Most major and moderate changes need re-submission, and every re-submission risks a delay. That makes accuracy in the first submission critical. It takes close attention to detail and a clear understanding of the requirements for each target market.

Regulators update labeling requirements often to reflect new scientific evidence or safety concerns. Keeping every artwork file aligned with those changes is an ongoing job, not a one-time check.

The most reliable way to avoid delays and penalties is to get the artwork right from the start. That needs a review process that covers regulatory, content, language, formatting and design requirements together, rather than in separate hand-offs where one team's fix undoes another's.

Right-first-time is a process outcome, not a reviewer outcome.  

Challenge 5: Managing Multiple SKUs

Pharma companies often carry many Stock Keeping Units (SKUs) for a single drug. The same medicine can come in different dosage forms, pack sizes, strengths or formulations. Each SKU's artwork has to reflect its own specific details while staying compliant.

Managing those variations is a logistical nightmare on paper-based processes or disconnected standalone tools. One safety update can touch dozens of SKUs, and each needs the same change made the same way.

Companies need cross-functional, end-to-end labeling and artwork processes that are time-efficient and traceable. That keeps on-time completion high however many SKUs are in play.

The practical fix is to manage shared content once and reuse it everywhere.  

Challenge 6: The Multilingual Maze

The European market is uniquely demanding on language. Under Article 63 of Directive 2001/83/EC, the labeling particulars and the package leaflet must appear in the official language or languages of each Member State where the medicine is sold. Multilingual packs are allowed, but only if the same information appears in every language used.

Separately, the Falsified Medicines Directive (FMD) requires safety features such as a unique identifier and an anti-tampering device on prescription packs. Both sets of rules land on the same carton, which leaves less space for more text.

Keeping every language version consistent needs careful planning and a robust artwork process.  

Challenge 7: Leaflet Content Accuracy

Most pharma packs include a patient information leaflet (PIL) with detailed information on the medicine, dosage, side effects and drug interactions. PILs come in different languages depending on the market, and keeping every version accurate is a demanding proofing job. Manually proofreading multilingual leaflets is slow and leaves room for error, however careful the reviewer.

Leaflets are also going digital. The EU pharma package lets each Member State decide whether the leaflet is provided on paper, electronically or both, with a printed copy available on request.

That shifts the accuracy problem rather than removing it. The printed leaflet, the carton and the ePI all have to say the same thing, and they will be updated on different schedules.

The answer is a single approved source for leaflet content.  

How ManageArtworks Clears Them

The seven hurdles share a few root causes: content that lives in too many places, checks that happen too late, and no link between what was approved and what was printed. ManageArtworks addresses them as one connected process.

Compliance before submission: ComplAI checks artwork against the regulatory requirements of each target market while the file is still in design. Gaps surface early rather than in a regulator's response, which is what pre-market approval and right-first-time submissions depend on.

One source for approved content: Copy Manager holds approved text as reusable content, so a change made once flows to every SKU and leaflet that uses it. The Digital Asset Library does the same for logos, symbols and imagery. That keeps multi-SKU portfolios and leaflet text consistent, on paper and in ePI.

Faster, targeted review: Proofing & Compare shows reviewers exactly what changed between versions and checks each translation against its approved source. A class-wide safety update is reviewed against the last approved artwork, and a dropped warning in one language is caught before it reaches a market.

Verification at print: Print Inspection compares printed components against the approved artwork, so a mismatch like the ValuHealth inner label is flagged before the lot ships.

A connected platform gives regulatory, labeling, design and quality teams one end-to-end view of each artwork job. It makes the process more transparent and collaborative, uses resources better, and makes edits faster and more accurate.

With that in place, pharma teams can respond to regulators with less effort, get approvals faster, avoid costly delays, and protect revenue in every market they serve.