Innovative Approaches in Regulatory Affairs: Leveraging Artificial Intelligence and Machine Learning for Efficient Compliance and Decision-Making.

Artificial Intelligence (AI) and AI-driven technologies are transforming industries across the board, with the pharmaceutical sector emerging as a frontrunner beneficiary. This article explores the growing impact of AI and Machine Learning (ML) within pharmaceutical Regulatory Affairs, particularly in dossier preparation, compilation, documentation, submission, review, and regulatory compliance. By automating time-intensive tasks, these technologies streamline workflows, accelerate result generation, and shorten the product approval timeline.

Training and education in pharmacovigilance: The experience from the Pharmacovigilance Programme of India.

For a robust Pharmacovigilance system in a country, training of healthcare professionals is of utmost importance. The training is the integral part of continual improvement in any quality management system. The present article describes the different training modules and experience from the Pharmacovigilance Programme of India (PvPI) and emphasizes that if training and education elements with special reference to pharmacovigilance are implemented for all concerned stakeholders in a healthcare system, the efficiency of deliverables will be improved and objectives of the organization can easily be achieved.

Minimizing the risk of ethylene glycol and diethylene glycol poisoning in medications: A regulatory and pharmacopoeial response.

Pharmaceutical and personal care products, including syrups and toothpastes, extensively use glycerin, sorbitol, and propylene glycol. However, past incidents of ethylene glycol (EG) and diethylene glycol (DEG) contamination in these products have raised serious health concerns. Recently, several child deaths linked to contaminated cough syrup consumption have heightened concerns regarding the safety of Indian pharmaceuticals.

Deciphering the US Regulatory Framework: Comparison Between Oncology Biosimilars and Reference Biologics.

Biological oncology agents are vital in cancer care, but their exorbitant expenses present obstacles for patients, families, healthcare professionals, and insurance providers. The advent of biosimilars represents a transformative solution, offering more affordable alternatives after the expiration of biologics patents. Biosimilar agents, similar to biological agents in structure, function, safety, and immunogenicity, enhance healthcare accessibility, improve outcomes, and reduce costs.

Expedited pathway insights: Unveiling oncology and non-oncology drug approvals and withdrawals of USFDA and EMA.

Background: Prior to entering the market, health authorities conduct a rigorous evaluation of compiled information for drugs delaying its entry. To address this void expedited pathways are introduced.

Methods: In this study, both oncology and non-oncology drugs approved through various expedited pathways from the US and Europe have been scrutinized using the USFDA's Novel Drug approvals from 2020 to 2023 and EMA's Human Medicine Highlights 2020 to 2023.