The Transition To E-Labeling Is More Than Uploading PDFs

A conversation with Afrah Mujeeb, Northeastern University

E-labeling for pharmaceuticals isn’t as simple as uploading a PDF to a website. Unlike most consumer products, where digital manuals have replaced paper-based ones almost entirely, pharmaceutical labeling is tightly regulated and deeply tied to patient safety, accessibility, and compliance.

But the transition is complex. It involves regulatory hurdles, usability testing, and hybrid systems that must accommodate both digital and paper formats.

Afrah Mujeeb, a graduate student at Northeastern University and part-time consultant with FDA Blueprint, has studied these challenges firsthand. At the RAPS Convergence conference in October, she shared insights from a national pilot program in Singapore aimed at reducing paper waste and improving label accessibility.

As combination products make it easier for patients to administer advanced therapies at home, the need for clear, accessible, and multilingual instructions becomes increasingly urgent.

E-labeling offers a promising solution. It can assist patients by providing instructions in their native languages, incorporating visual aids like demonstration videos, and offering alternatives for patients with impaired vision.

On the manufacturer side, digital labels offer ultimate flexibility to deliver approved changes instantaneously rather than redistributing pamphlets. They also minimize the wastepaper footprint and logistics that go along with making sure each bottle, vial, or auto-injector has paper instructions to go with it.

In Singapore, the Health Sciences Authority (HSA) ran a voluntary pilot program for drug companies approved to market therapeutic products within the island nation. The program, which was launched officially in 2021, allows companies to distribute e-labels with or without printed copies.

In the conversation that follows, Mujeeb discusses the practical and regulatory realities of making the shift to e-labeling. The transcript has been edited for clarity.

Can you start with a quick overview of the pain points in transitioning to or implementing an e-labeling program for pharmaceutical products?

For drugs, pharma, or medical devices, the industry is very regulated, not like a consumer product. Every change, every minute detail, has to be reviewed and approved by authorities. Even for changes as simple as adjusting the font, we must make sure that they’re meeting the requirements of the authorities, be it FDA, EMA, or, as I mentioned in my talk, HSA for Singapore.

It's not easy to switch from paper to e-labeling overnight. We have to make sure that our systems are validated and our teams are ready for electronic change.

Speaking specifically about the digitalization process — taking documents and making them interactive and readable online — can you talk about some of the specific challenges of that? In my simple mind, I'm just imagining hiring an intern to upload a bunch of PDFs to a server somewhere.

One of the biggest challenges is usability testing. EMA and FDA both require usability testing for e-labeling. To start, we have to do a risk assessment. For us to move into digitalization, we have to make sure that the content is readable, the font is good. We have to ask questions like, “What if the patient can’t access the QR code?”

We have to establish the risks and potential impacts on the patient and on their health and then ask, “How are we going to mitigate these risks?” So, it's as simple as uploading and digitalizing, although that step is important and complex on its own. The PDFs should be readable and accessible with a good archival system to trace each document. Every minor change, every document, and every label has to be traceable.

You described a hybrid system with e-labels and paper. From a complexity standpoint, it seems more complex, not simpler, because you’re providing the digital version on top of the paper label. How does the hybrid system make it simpler?

Of course, the start is always more difficult. FDA and EMA both require paper; if a patient requests a paper-based label, IFU (instructions for use), or package insert, then we have to provide them. It's a requirement.

But it's not easy to abruptly switch from paper to digital. This approach bridges the practical gap and regulatory gap. So, that's how we can first start with both and then later switch to e-labeling completely.

Also, the regulatory authorities are open to these things, and that's why they are implementing pilot programs. And then, yes, once we see that it's going to work out, I think in the future labels are going to be digitalized completely.

Are regulatory bodies getting together on this and harmonizing, or is it still a patchwork?

It's still a patchwork, and it's not fully harmonized. FDA last year published guidance on e-labeling. They are taking small steps. The EMA has electronic IFU documents. For both, we still need to have paper-based labels as well. If someone requests it, then we have to provide it, and we need a compliant website.

Singapore has been a leader in adoption. They already did a pilot program for prescription-based products and they have done a good job. They have saved 20 tons of paper, which equals 350 trees annually.

About The Expert:

Afrah Mujeeb is a research assistant studying drug, biologics, and medical device regulatory frameworks at Northeastern University. She’s also a consultant with FDA Blueprint. She sits on the committee for the Regulatory Affairs Professionals Society (RAPS) and serves as a regulatory affairs project manager for the Parenteral Drug Association. Connect with her on LinkedIn.