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Labeling of Pharmaceutical Products: Challenges and Standardization

December 10, 2019
Labeling Automation

Labels of pharmaceutical products act as an “instruction manual” to the end-users hence need to be standardized. This standardization process is often met and overcome multiple obligations like compliance issues, failure to timely update labels, non-compliance risks and so on. Some of the additional label data points may results to highlight several issues that did not come up during drug manufacturing. Hence it is time to re-evaluate the existing label information to meet the regulatory compliance, quality standardization and thus conclude a remedy for the same.

Compliance Issues

Many pharmaceutical companies are facing the compliance issues with the applicable regulatory authorities, and this becomes a ongoing obligation on their top priority list to do effective marketing. The regulatory process is extremely complex when it comes to labeling as it is an integral part of the quality system. This being such an important matter has resulted in several assessments that have highlighted some major compliance issues like:

  • Delay in submitting the newly updated safety norms to be present in the product labels such as USPI, summary of product characteristics (SPC), patient information leaflet (PIL) and other local labels..
  • Marketing authorization holder’s (MAH’s) website getting overly filled by multiple variants of USPI, SPCs and PILs, etc.
  • Failure in providing or updating the safety information (e.g., warnings/ precautions, contraindications, ADRs, etc) for several products that might be clinically significant.
  • Authorized information about the products is being lost as proper variation applications are not finding their ways to the regulatory authority.

Discrepancy in labeling can be in several forms like warning signs present in core datasheets but failure to implement in local labels and vice versa, risk communication, and risk management do fall under this category.

Need to Update Labels

Safety comes first in this industry and hence all pharmaceutical product labels must be up-to-date. Failure to timely update of safety information in drug labels has turned out to be expensive in recent times such as product recall, penalties, partially or complete withdrawal from the market, etc. This failure, in turn, results in losing trust or changing public opinion about the company standards or quality form of labeling.

Communication and organization is the key to have an alignment between the global product information and the regional or local label information and this would immediately have some positive effect on product updates.

Heath authorities are recommending that MAHs should review their labeling information on periodic basis (annually as a minimum) until any priority issues. Moreover, when new information comes to light the previously available labels are considered to be older and misleading and this potentially creates the compliance issue. To avoid such situations each marketing authorized holder thoroughly updates the necessary information in the marketed product labels.

Noncompliance Risks

Pharmaceutical labeling is a highly complex and regulated process, and is an integral part of the quality for any manufacturer or company holder. However, companies are constantly facing the compliance issues mainly while they doing marketing in multiple countries.

The major issue being noted as market withdrawals (partial or complete), huge penalties from the health authorities due to data inconsistency (core safety information) with the reference label data. This would further create aching to the organization’s ongoing processes as scrutiny by the regulatory authorities will also increase. Due to this wounding process companies also may loss the huge amount and time towards the product approvals and renewals.

On the other hand, the labeling updating process poses a different level of challenges. The guidance available for modifying labeling text is not standard and thus leads to marked confusion among the marketing holders for product recalls from the health authorities. There are chances to avoid this situation by resubmitting labeling information provided in a reorganized manner.

Standard Labeling

There are no specific global standards for information provided in prescription drug labeling; there is only an overall trend toward increasingly detailed documentation. When exporting drugs, manufacturers either need to consider many different labeling requirements or decentralize their labeling and packaging as per the region or country requirements to meet the local compliances. CCDS is the core document that is timely updated by the manufacturer based on new information is available related to the product safety and quality. This leads to necessary changes to be done in regional/local labels to meet the regulatory compliance. Labeling requirements are provided in a wide range by stating that drug manufacturers are responsible for ensuring the quality, packaging of the product. However, no specific regulations are provided in any specific note on how to accomplish this information.


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