In times of emergencies like war, disease outbreak, natural disasters etc that lead to a rise in casualties, humanitarian support such as donations may be required. These donations can range from basic items like clothing to more technical complex items such as medical devices. While donations can be crucial during emergencies, they also bring challenges […]
AMDF: Ensuring the Safety of Donated Medical Devices Read More »
Japan has a robust regulatory framework for pharmaceuticals and medical devices, which includes specific requirements for In-Country Clinical Caretakers (ICCC). Foreign manufacturers that wish to penetrate the Japanese market must appoint an ICC, who resides in Japan, to sponsor the clinical trials on their behalf. Thus, they play a crucial part in ensuring that foreign
Japan PMDA: The Role of In-Country Clinical Caretakers Read More »
The cosmetics sector in South Korea has witnessed impressive expansion and gained global acclaim. The Ministry of Food and Drug Safety (MFDS) has implemented a strong regulatory system, primarily overseen by the Cosmetics Act, to guarantee the safety and quality of cosmetic items. The Cosmetics Regulatory Framework, in conjunction with additional regulations, plays a crucial
Regulatory Framework for Cosmetics in South Korea Read More »
At the turn of the millennium, guidelines for post-marketing safety reporting of herbal medicines were introduced by the World Health Organization (WHO) in the period between 1999 and 2001. The fact that more than 158 million people in the United States alone spent over 17.6 billion dollars on herbal medicines in the year 2000 is
Pharmacovigilance in Herbal and Alternative Medicine Read More »
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
Supporting Labelling Compliance with Searchable Databases Read More »
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
Swissmedic: The Importance of Real-World Evidence in Regulatory Decision Making Read More »
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
Modernization of Cosmetics Regulation Act Read More »
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
Ensuring Safe Use of Medical Devices in Healthcare Facilities Read More »
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
Evaluating the need for comparative clinical efficacy studies in biosimilar development Read More »
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
Prescription-Drug-Use-Related Software Read More »
