Many tools have failed to keep labeling processes up to date by maintaining regulatory standards. When you are looking for a tool, it needs to meet all labeling expectations starting from labeling life cycle, content changes, safety compliance, tracking history, artwork and packaging managements, quality of labeling document submission, tracking supply chain and even notifying on compliance responses and queries for all marketed drugs in a labeling tool.

Some automated drug labeling tools provide on-demand label creations, annotations, label classifications, conversions, and data extractions by using a set of business rules to turn unstructured label data into structured label data and build corresponding regulatory standards. Often data science techniques like artificial intelligence algorithms, machine learning, etc. are also used. Some software vendors are working on labeling modules by setting up different combinations assigned by user or system so that they can choose who or what is doing the labeling documentation. To qualify for the drug labeling process, the tools need to be managed by an integrated workforce who will ensure labels are accurate and consistent throughout the regulated document. In addition, the end-user should be able to view and use analytics used in monitors the accuracy of labeling life cycle management.

2. Challenges in Drug Safety updates and Use Cases

Every labeling document needs to be quality checked before its submission so that it can face the challenges of critical labeling compliance during the post-marketing surveillance stage. The challenges might be drug-related and on patient’s real-time experience after using a medical product. So, if any safety challenge occurs, manufacturers need to inform regulatory bodies and other stakeholders or distributors about it. Generally, the safety challenges are related to warnings and precautions, drug-drug interactions, drug-food interactions, adverse reactions, contraindications, indications, and other instructions on using drug products.

Below are common safety challenges in US FDA and EMA regions:

• Failure to update generic label from reference listed drug label.
• Failure to implement Artwork instructions, formats, and standards for all marketed drug labels.
• Failures and significant delays to submit safety variations required to update the safety sections of United States Product Insert (USPI), summaries of product characteristics
  (SmPC), and patient information leaflets (PILs) or educational guides.
• Missing data on clinical use, safety information on indication, contraindications, adverse reactions, special warnings, and precautions and use in specific populations for many
  products.

3. Standard Multilingual Labeling Documents:

Pharmaceutical manufacturers are looking to extend existing products in new markets. That requires labeling documents or packaging artwork labels to be accessible to the public and local regulatory bodies in that specific market. For that, all labeling documents and artwork labels must be created in country-specific languages, but it is critical to document content information specifically for more number of emerging markets/countries for drug products. In that case, all labels need to be customized accurately into local languages, making communication and identification of labels easier for end-users.

4. Difficulties in implementing Packaging Artwork Labeling standards:

Packaging Artwork labels are very important in product identification and tracking status of labels during marketing and supply but it needs prior approvals from health authorities. FDA and EU implement and mandate guidance on package label requirements. Manufacturers need to communicate with artwork designers and keep them updated and even respond to the queries of health authorities. Some software vendors/enterprises are using plugins and developing techniques for standard label designing formats, these will be very useful when you create or update artwork packaging labels. But it has its limitations when you create different types of label sizes, and label content to be supervised by artwork teams and technical teams.

Package Labeling faces new challenges in adopting regulatory standards and mock artwork design. Especially, justification is needed for “what content to be added to a product label and how to implement multiple package labels for the same product”. The software vendors/enterprises are trying to manage product labeling and artwork at the same time. They are using technical algorithms to maintain an end-to-end life cycle on artwork labels. Pharmaceutical manufacturing companies are trying to streamline the entire process starting from the creation of the labeling document, artwork labels, and even the review process ending with the approval. There is a rise in the demand for a central repository to derive everything from one end.

5. Keep Your Standard Labeling documents up to date:

To complete safety labeling compliance and challenges, manufacturers must follow their standard operating procedures already in place to consolidate the required clinical, regulatory, and technical functional teams with the required expertise. The teams should be using a communicational process and ready to respond to safety alerts, where interactions with local or global teams are tracked and the global labeling team has informed to handle the on-demand requirements of the local labels and to maintain alignment with the reference core labels and other in-house labels. Pharmaceutical Companies need to have an own complete strategy to identify the roles and responsibilities of different shareholders or distributors and have a clear communication plan that focuses on meaningful and real-time content to advance the safety signal to the labeling documents and beyond.

As per labeling standards, all innovator and generic manufacturers should be maintaining their drug products according to demand standards labeling guidance, and regulations. In the US and EU markets, it is PLR and PLLR. QRD structured labeling documents are necessary to meet product labeling in accurate for final submission. Based on regulatory review decisions and PMS, PSUR reports, the new information can be added into labeling documents and it should be up to date with all stakeholders or distributors in a supply chain as well as health authorities of marketed countries.

ZERO Guidance or Regulations given by any agency for Labeling exceptions. That means whether your regional teams are disrupted because of Covid, teams cannot follow-up labeling changes on time or people doing WFH, or other changes, your labeling obligations remain SAME, if not increased more

Label compliance may not be high priority for your compliance teams or health authorities or some of you as there are other priorities. When dust settles, some of your Labeling gaps might pose major challenges and companies will have to incur extra costs to bring any label non-compliance to order. From studies in the past, for a business, the consequences are costly, with the average label change sitting at $350,000.

In addition, the risk of non-compliance is significant. From the potential regulatory fines and loss of brand reputation, temporary forced shutdown of a full production line and cost of re-mediating, not having a validated system and process in place could have a potentially catastrophic impact on business.

Labeling Digitization to Rescue

Digitization & Automation offers traceability that not only mitigates potential risks but also drastically improving labeling efficiency.

For existing labels, with the help of inbuilt translation engine, reverse translations can be done on existing regional/country labels and compared to either CCDS, USPI or SmPC. This will help identify existing gaps / violations faster without having to execute “special” compliance projects saving cost an reducing pain for the teams (as labeling teams don’t enjoy doing these tasks anyways)

For future labels, technology will help in achieving a comprehensive view of labeling operations and touch points in relation to the rest of the organization minimizing your attempts to resolve any issues in isolation. With Label Content digitization, changes and life cycle can be managed holistically, rather than managing with out-dated process of managing labels/documents following painful processes of maintaining versions, copies, track modes etc.

With the ever changing landscape of labeling technology, there are now solutions on offer fit for every type of organization at all budget ranges giving modular options. Yet, for many who get satisfied with an EDMS, the implementation of these newer tools/technologies is still accompanied with apprehension (for some lack of time and for others control issues). These automated solutions can end the recurring insanity of labeling challenges. Digitization & Automation will help future proofing operations within the overall labeling supply chain.

Below is one of the medical devices type as per new recommendations.

Modifications for Sterilizers, Disinfectant Devices, and Air Purifiers:

FDA has recommended standards (TABLE 1) and labeling modifications (TABLE 2) on sterilized or disinfected conditions to patients and healthcare providers for usage of sterilizers, disinfectant devices, and air purifiers during this public health emergency.

TABLE 1: Modifications/applied standards for Sterilizers, Disinfectant devices, and Air purifiers

Table 2: Labeling Modifications for Sterilizers, Disinfectant Devices, and Air Purifiers: