Speed to market is king in the fast-moving world of consumer goods. Yet, countless hours are spent reviewing packaging artwork before going to market. Traditional review methods are time-consuming and prone to human error. A single mistake in an ingredient list or a barcode could result in lost sales or shelf space, a recall and damage to the brand reputation.
Pharmaceutical packaging plays a critical role in ensuring the safety, efficacy, and quality of medications. The US Food and Drug Administration (FDA) closely regulates packaging and labeling, as well as manufacturing processes in pharmaceutical packaging. Ultimately, these regulations and guidelines safeguard patient health.
Food labeling plays a crucial role in protecting consumer health by providing information relating to food sources, nutrition and safety. Accurate and informative food labeling allows consumers to make informed dietary choices. Compliance with food labeling regulations is not only a legal requirement but also impacts brand reputation.
The way patients access critical medication information is evolving. In this expert discussion, Philipp Thomas from Schlafender Hase speaks with Manuela Wiegand, pharmacist at Rote Liste® Service GmbH, about Gebrauchsinformation 4.0 (GI 4.0®)—Germany’s move toward digital patient information leaflets.
In mid-2024, new US Food and Drug Administration (FDA) rules came into force for prescription drug advertising on television and radio. These rules are designed to promote more clarity, [1] and we can also expect future changes affecting social media influencers, especially when promoting weight loss drugs.
As cosmetic regulations evolve, maintaining labeling standards is becoming increasingly complex. Here we explore some key changes in cosmetic labeling regulations and highlight how to ensure your products meet all requirements.
Health Canada has announced changes to the filing requirements for Extensible Markup Language (XML) Product Monographs (PMs), signaling a shift toward enhanced digital documentation standards. The first phase of these requirements come into effect on July 18, 2025. These updates will impact regulatory teams, requiring adjustments in their processes to meet the new expectations.
Despite stakeholders’ efforts to harmonize the medical device industry across regulatory jurisdictions, manufacturers face significant challenges in achieving global regulatory compliance. Gradually, however, we are seeing greater recognition globally of quality standards. In regions beyond Europe and North America, harmonization initiatives are well underway.
Think back to the early days of labeling – when medicines were sold by salespeople at events resembling circuses more than genuine health events. Consumers often had little to no knowledge of what was inside the medication bottle. In fact, the first US regulation on labeling, introduced in 1906, merely required that any listed contents were truthful.
Serialization in pharmaceutical packaging and drug labeling is crucial to product safety, regulatory compliance, supply chain efficiency and the fight against counterfeit drugs.
