Future-Forward: 8 Key Trends Transforming Drug Labeling
1. Serialization and product authenticity
Serialization in pharmaceutical packaging and drug labeling is crucial to product safety, regulatory compliance, supply chain efficiency and the fight against counterfeit drugs. Unique information such as that stipulated in the US by the FDA Drug Supply Chain Security Act (DSCSA) laws [1] on serialization, and the Falsified Medicines Directive (Directive 2011/62/EU) [2] in the EU, goes hand-in-hand with technologies such as IIoT, AI and blockchain to enhance data transparency and real-time tracking in the supply chain.
2. Patient-Friendly Labeling
Pharma packaging and labeling is patient-friendly when it is clear, informative and easy for patients to understand. This promotes proper use and adherence. It is estimated that about 100,000 people die in the US alone due to not taking medication as prescribed. [3] However, patient-friendly labeling is also about how labeling is delivered – and here, e-labeling is the industry-changer. A European working group has produced an interesting paper on patient-friendly aspects in terms of content (see here). [4]
E-labeling is more than a trend, it is being mandated by regulatory bodies around the world. Apps allow patients to view digital labeling by scanning a QR code or using near-field communication and a smartphone (NFC; or in some cases a simple URL leading to a website). Information can be better exchanged and personalized to particular patient groups and in multiple language versions, overcoming the space limitations of physical labeling. This is the future everywhere – get ready for it. Start here, by reading our e-labeling book.
3. Enhanced packaging for usability and accessibility
Usability is about the ease of use, while accessibility is about is about having as few barriers as possible. It is inclusive and avoids wastefulness. Braille is voluntary in the US. The EU takes a different approach, making it mandatory. Accessible pharma packaging allows wider, more-independent patient reach, better-informed decision-making, and greater patient satisfaction. Electronic labeling offers many opportunities to make labeling more accessible as it is suitable for text-to-voice applications, or you can produce multilingual versions that would otherwise be impractical due to limited space on pharma labels.
4. Integration of digital technology in labeling
E-labeling is a breakthrough in how we share information. With the advent of Fast Healthcare Interoperability Resources (FHIR) format, information can now be shared more freely and reliably in apps and using QR codes or near-field communication (NFC) on smartphones to take the patient to a labeling platform. This opens up new opportunities to bundle patient labeling resources and information for patients (e.g. labels for all drugs a patient takes, and with a personal health record, along with other health records).
5. Compliance with Sustainability and Environmental Standards
The important discussion around drug residues and chemical production tends to overshadow sustainability and environmental standards in labeling itself. Electronic labeling has the potential to vastly reduce the amount of physical paper labeling required, and that is a boon for the environment. More information can also be provided on environmental aspects (e.g. on the proper disposal of medications).
Other aspects to consider are compliance with the European Union’s Green Deal [5] and the REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) requirements [6], as well as international ISO standards [7] on environmental management systems. Eco-friendly labeling and packaging (e.g. biodegradability, safe disposal instructions) is on the rise.
6. International Harmonization of Labeling Standards
Today’s trend is toward harmonization. European integration has been a key force in harmonization, but the development of other free-trade zones such as Mercosur in Latin America, the North American Free Trade Agreement (NAFTA), and the African Continental Free Trade Area (AfCFTA) are also drivers. In the case of Africa, harmonizing highly fragmented markets offers opportunities for greater local production and intra-Africa trade in medicines. This reduces import dependence. This World Economic Forum report provides interesting reading (see page 14 for pharmaceuticals) on harmonization in Africa. [8] Furthermore, within a World Health Organization framework, the African Medicines Regulatory Harmonization Initiative (AMRHI) is promoting coordination in technical, legislative, and procedural areas. [9] Since 1990, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has actively worked to establish technical standards.
7. Greater post-market surveillance and more-frequent labeling updates
Post-marketing surveillance is a cornerstone of drug regulation as not all possible side-effects of a product can be anticipated prior to authorization. Companies must continuously monitor real-world signals and gather real-world data. A risk management strategy must be in place in order to implement a labeling update on safety and efficacy as quickly as possible. Furthermore, e-labeling means faster updates, but also managing higher volumes of information.
8. New technologies, regulatory change and training
Flowing on from earlier points, FHIR is changing submission formats, e-labeling is increasing product transparency through the availability of more information, patient-centric healthcare is on the rise, and we can expect AI to play a greater role (find out more here in the area of promotional review) [10]. Regulatory change will accompany the technological changes, and also drive them. This requires new skills among professionals in the industry.
How TVT Tackles Drug Labeling Challenges
As pharmaceutical labeling evolves, challenges such as ensuring the accuracy of serialization, managing dual physical and electronic labeling, verifying accessible packaging like Braille, and keeping up with international harmonization and frequent updates continue to pose significant hurdles. Additionally, sustainability standards and the integration of digital technologies require careful navigation to maintain compliance and operational efficiency.
TVT offers an all-in-one solution to address these challenges. By automating proofreading and verification processes, TVT ensures error-free labeling, boosts compliance, and increases productivity. From verifying barcodes and Braille to handling dual labeling formats and integrating with digital platforms, TVT provides the tools necessary to stay ahead of regulatory demands. With TVT, companies can achieve labeling accuracy, reduce recall risks, and maintain confidence in a rapidly changing landscape.
Read more about trends shaping pharma and the medical device industry in The Road Ahead: Exploring Regulatory Trends Shaping Med Device and Pharma in 2025.
1. https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa2. https://health.ec.europa.eu/medicinal-products/falsified-medicines_en
3. https://news.uga.edu/patient-friendly-prescription-labels-boost-medication-adherence/
4. https://aesgp.eu/content/uploads/2024/03/AESGP-EFPIA-MfE_PP_Patient-information-on-medicinal-product-_2024.pdf
5. https://www.consilium.europa.eu/en/policies/green-deal/
6. https://echa.europa.eu/regulations/reach/understanding-reach
7. https://www.iso.org/standard/60857.html
8. https://www3.weforum.org/docs/WEF_Friends_of_the_Africa_Continental_Free_Trade_Area_2023.pdf
9. https://www.who.int/teams/regulation-prequalification/regulation-and-safety/regulatory-convergence-networks/harmonization
10. https://www.schlafenderhase.com/shblog/regulatory-tools-revolutionizing-promo-review
