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Supporting Labelling Compliance with Searchable Databases

Blogs, Labeling /

Biopharmaceutical product labelling is a multifaceted undertaking that spans various products and markets, encompassing diverse formulations and dosages.  The challenge lies in consistently upholding pharmaceutical labelling compliance throughout this intricate process. Ensuring pharmaceutical labelling compliance involves following regulatory requirements and guidelines when developing and updating product labels, such as Summary of Product Characteristics (SPC), Patient […]

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Swissmedic: The Importance of Real-World Evidence in Regulatory Decision Making

Blogs, Regulatory /

Real-World Evidence (RWE) refers to clinical evidence derived from real-world data (RWD) collected outside of traditional clinical trial settings. The significance of RWE in regulatory decision making has been growing worldwide due to its potential to provide valuable insights into the safety, efficacy, and effectiveness of therapeutic products. While traditional clinical trials remain the gold

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Modernization of Cosmetics Regulation Act

Blogs, Regulatory /

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a significant milestone in the regulation of cosmetic products in the United States. This comprehensive legislation, enacted to enhance consumer safety, imposes a series of requirements and obligations on cosmetic companies, facilities, and responsible persons within the industry. MoCRA not only expands the authority of

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Ensuring Safe Use of Medical Devices in Healthcare Facilities

Blogs, Medical Device, Pharmacovigilance /

The safe and effective use of medical devices in healthcare facilities is not merely a matter of convenience; it is a moral obligation. The welfare of patients and the quality of healthcare services depend on the responsible use of these devices. Accidents involving medical devices can have dire consequences for patients. These accidents may result

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Evaluating the need for comparative clinical efficacy studies in biosimilar development

Blogs, Regulatory /

Introduction Long-term safety, efficacy, and immunogenicity data of licensed biosimilars do not raise concerns. State-of-the-art analytical and functional testing, as well as robust pharmacokinetic (PK) and pharmacodynamic (PD) studies are sufficient to demonstrate biosimilarity. In in-vivo animal studies and large confirmatory efficacy and safety studies are generally not needed. This blog provides and overview on

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Prescription-Drug-Use-Related Software

Blogs, Labeling, Regulatory /

Introduction With the advancement in digital technology, the development of prescription drug use-related software has surged, offering innovative solutions to enhance patient care, monitor drug adherence, and improve healthcare outcomes. The U.S. Food and Drug Administration (FDA) recognized the need to address software outputs related to prescription drugs and combination products. Prescription drug-use-related software is associated

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UK MHRA International Recognition Procedure

Blogs, Regulatory /

The UK MHRA’s Latest Update on the International Recognition Procedure Introduction The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has taken a significant step towards enhancing its regulatory processes. The reason behind this step is to facilitate medicine access by expediting their approval. The MHRA has recently released comprehensive guidance on

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Formal Meetings for Biosimilar Product Development with the US FDA

Blogs, Medical Writing /

Comprehending the Key Components of Formal Meetings for Biosimilar Development with the FDA Introduction The development and approval process for biosimilar or interchangeable biosimilar product development is a complex journey. It requires close collaboration between pharmaceutical companies and global regulatory consulting authorities. In the United States, the Food and Drug Administration (FDA) plays a pivotal

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Paediatric Investigation Plan in Medicinal Product Development

Blogs, Medical Writing /

Navigating the Paediatric Investigation Plan and its Significance in the Development of Medicinal Products. The development and authorization of medicinal products for paediatric use are essential for ensuring the health and well-being of children. However, conducting clinical trials involving children requires a distinct set of considerations and ethical standards. To address these challenges, the concept

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