The European Medicines Regulatory Network (EMRN) has adopted a common electronic Product Information (ePI) standard for human medicines. The common ePI standard was one of the major projects undertaken by the European Medicines Agency (EMA), the National Competent Authorities (NCA), and the European Commission (EC). The EU Network Data Board adopted the EU ePI common standard in September 2021, and the announcement was made on February 22, 2022.
As you may know, every country has its own set of regulations when it comes to labeling food products. Food labeling is a legal requirement and provides a wide range of information to help consumers make informed food choices. It protects public health and safety by displaying ingredients, use-by dates, allergens, advisory/warning statements, instructions for storage and preparation, etc.
A pharmaceutical label is a monologue between the drug manufacturer and the patients. Miscommunication of any kind can affect the end-user. To protect the interest of the patient population, global Health Authorities (HAs) closely monitor pharmaceutical labels and indications of pre-approval. There are various components to a label and with each additional component, the chances of errors increase gradually.
Drug labeling and package leaflets play an important role for both patients and healthcare professionals in the safe and efficient use of the medication. Hence, the approval of the labeling content, Patient Information Leaflet (PIL), and Summary of Product Characteristics (SPC) are integral components of the marketing authorization process.
Any food product or ingredient, such as nuts, seafood, peanuts, gluten-containing cereal, latex, penicillin, etc., can pose allergies when ingested into a human body. According to research, generally, food allergies affect 2.5% of the general population.
Recently, Per the revised Manual of Policies and Procedures (MAPP) of the United States Food and Drug Administration (USFDA) has proposed new labeling rules under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act (FD & C Act). This Section covers the FDA’s approval of an Abbreviated New Drug application (ANDA) even after a few changes in the labeling for the Reference Listed Drug (RLD). When the FDA’s approvals of labeling changes for the RLD and the ANDA are scheduled simultaneously, the revised process needs to be followed.
While creating compliant packaging, controlling the labeling flow and its implementation through artwork, supply chain and printing involves several internal and external stakeholders. Following up with all the teams to meet the time-critical mandates and deadlines can be challenging. Therefore, it is crucial to have a dedicated platform to handle the lifecycle changes of product labeling.
The global pharmaceutical industry faces a plethora of challenges when it comes to drug labeling. Ever-changing Regulatory requirements, products that are no longer patentable, and market pricing pressures force the industry to aim for the competitive advantage through increased efficiency.
This article focuses on potential roadblocks in streamlining the labeling processes in the current situation as well as solutions to help companies better comprehend labeling considering these issues.
Here are four key labeling challenges that a company may face:
As the use of pharmaceuticals can have a substantial impact on a patient's health and well-being, the information on the label must be clear and correct. It is particularly true when it comes to usage directions, expiration dates and component lists. Thus, an audit of pharmaceutical labeling operations is required.
As a significant aspect of Regulatory compliance, data accuracy stands as one of the most critical criteria in medicine labeling. According to the FDA and MHRA studies, roughly 51 percent of auditing issues are associated with labeling-related documents.
Communication effectiveness across the marketing platforms is evaluated primarily based on how well the content engages the audience or, in the case of brands, the consumer. In healthcare, the information available on these platforms is diverse. There are many variations to multiple content types therefore, such boundless volume of content and technical terms may overwhelm the audience with information.