In the pharma regulatory arena, the ICH guidelines alongside the health authorities play a pivotal role in ensuring drug product safety and efficacy. However, with the global reach of the pharmaceutical industry, harmonizing regulatory standards across diverse regions has become a critical imperative. This is where the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) steps in, collaborating with the FDA to streamline global drug development.
Why is Grasping Data Security and Selecting Compliant Software Vital in the Realm of Regulatory Affairs?
In today's digital era, data security and compliance are more than just buzzwords—they are critical components of success for any organization, especially in sectors such as life sciences, pharmaceuticals, medical devices, and similar fields. Regulatory compliance is a complex landscape, and with the increasing reliance on software and technology, it becomes paramount to understand why data security and choosing compliant software are essential.
Precision medicine stands at the forefront promising personalized and targeted treatments based on an individual's unique genetic makeup. As life sciences companies venture into the development of precision medicinal products, the regulatory landscape presents a complex terrain that demands strategic navigation.
In recent times, the emergence of nitrosamine impurities in certain generic drug substances has prompted a re-evaluation of industry practices. This blog takes a deep dive into the multifaceted world of nitrosamine mitigation, specifically in the context of generic drug products. Moreover, it also throws light upon considerations made for Nitrosamine Drug Substance Related Impurities. We explore the intricacies of maintaining quality, ensuring bioequivalence, and understanding the pivotal role of regulatory experts in this critical process.
Cosmetic products are regulated so that they are safe for regular/repeated use and efficacious as claimed or presumed. Historically, cosmetics were supposed to be a blend of overtly safe ingredients with an onus of safety lying majorly with the industry. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) signifies a turning point in the US FDA's jurisdiction over cosmetics, ushering in an era characterized by heightened safety and accountability.
The Modernization of Cosmetics Regulation Act 2022 (MoCRA) represents a pivotal moment in the US FDA's authority over the cosmetics industry, marking a significant update to the regulations established in the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938. Among the array of new requirements introduced by MoCRA, adverse event reporting stands out as a critical component. In this blog, we will delve into the essential requirements and best practices for complying with MoCRA's adverse event reporting provisions.
Good pharmacovigilance practices (GVP) are a set of guidelines established by regulatory authorities to ensure the safety of medicinal products. These guidelines provide a comprehensive framework for monitoring, evaluating, and reporting adverse drug reactions (ADRs). However, there are certain situations where exceptions or modifications to GVP may be necessary.
In the ever-evolving world of pharmaceuticals, ensuring patient safety remains a paramount concern. As new drugs emerge and treatment options expand, the importance of pharmacovigilance, the science of monitoring and evaluating drug safety, has never been greater. To address the growing complexity of pharmacovigilance tasks and enhance the effectiveness of drug safety surveillance, the industry is embracing the transformative power of artificial intelligence (AI) in pharmacovigilance and cutting-edge technology.
Japan is a key market for the pharmaceutical industry, but its drug approval process can be complex and daunting. If you are seeking to introduce a new drug into the Japanese market, you must understand the drug approval process and navigate it effectively.
This blog will answer eleven (11) of the most Frequently Asked Questions (FAQs) about the drug approval process in Japan. It provides a comprehensive overview and practical guidance for companies looking to navigate this intricate Regulatory landscape.
According to the World Health Organization (WHO), only 27% of lower-middle-income and low-income economies have national pharmacovigilance systems registered with the WHO program, compared with 96% of the high-income countries in the Organisation for Economic Co-operation and Development. ADRs are estimated to cause 2.6 million deaths each year worldwide, with a disproportionate number of these deaths occurring in developing countries.