Guideline for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and Biological Products
Artificial Intelligence (AI) is rapidly transforming various industries, including the pharmaceutical sector. Regulatory authorities are increasingly exploring AI-driven tools to enhance decision-making processes related to drug and biological product approvals. However, the integration of AI in regulatory science requires careful consideration to ensure transparency, reliability, and compliance with established guidelines.
CARES Act Section 505G: Modernizing OTC Drug Monographs
The CARES Act, signed into law on March 27, 2020, brought significant changes to the regulatory framework governing Over-the-Counter (OTC) drugs in the U.S. Section 505G, which was added to the Federal Food, Drug, and Cosmetic (FD&C) Act, specifically addresses OTC monograph drugs and aims to modernize their regulation. The new rules are intended to streamline and update how OTC drugs are brought to market, offering clearer pathways for both manufacturers and regulators.
Pharmacovigilance System Master File (PSMF): Its Importance and Regulatory Role in Ensuring Drug Safety
The Pharmacovigilance System Master File (PSMF) is a key regulatory requirement under the EU pharmacovigilance legislation, ensuring that medicinal products authorized in the European Union (EU) comply with the stringent safety monitoring and reporting standards. Its primary objective is to provide a detailed description of the pharmacovigilance (PV) system in place, documenting the structure, processes, and the responsibilities of stakeholders involved in drug safety.
FDA Modernizes the Electronic Submission Gateway (ESG) with ESG NextGen
The FDA is launching ESG NextGen, a modern, cloud-based system designed to improve the submission process. Key features include a unified submission portal, real-time tracking, enhanced cybersecurity, and API integration. This modernization expands bandwidth and storage capacity, allowing for a more seamless and efficient experience.
Kuwait Ministry of Health Marks Significant Advancement in Pharmaceutical Regulatory Digitalization
The Kuwait Ministry of Health (Kuwait MOH) has made an important leap forward in the pharmaceutical regulatory landscape by transitioning from the Common Technical Document (CTD) format to the Electronic Common Technical Document (eCTD). This move aims to streamline the submission process for new drug applications, enhancing efficiency and ensuring compliance with international standards.