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Biopharma Labeling Wish list 2021

December 17, 2020
Labeling Automation

1. Solutions to Inaccurate Labeling Automation Tools:

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.


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