Regulatory Pharma Blogs
What is Good Laboratory Practice (GLP) Good Laboratory Practice (GLP): The Principles of Good Laboratory Practice (GLP) set forth guidelines and standards for a quality system that manages the processes and conditions involved in planning, conducting, monitoring, recording, reporting, and archiving non-clinical health and environmental safety studies. These principles are applied to the non-clinical safety …
What is stability testing of new drug substances and products Stability testing of new drug substances and products the purpose of this communication is to detail the updates incorporated in Q1A(R) following the adoption of ICH Q1F \”Stability Data Package for Registration Applications in stability-conditions-table-2018. These modifications include: Adjustment of the intermediate storage condition from …
ASEAN common technical dossier (ACTD) for the registration of pharmaceuticals for human use: ASEAN Common Technical Dossier (ACTD) serves as a standardized framework for preparing comprehensive applications intended for the registration of pharmaceuticals and biologics for human use across ASEAN regulatory authorities. It outlines a structured Common Technical Dossier (CTD) format, facilitating efficient compilation and …
Procedure for export of Indian drug product in overseas market Procedure for export of pharmaceutical products Background pharmaceutical Procedure for export of pharmaceutical Indian drug product in overseas market India holds a prominent position globally in the pharmaceutical industry, ranking third. Oversight of these industries falls under the Ministry of Health & Family Welfare and …
Overview of Regulatory authorities and agencies of (Organization structure and types of applications): India United States European Union Australia Japan Canada Background Regulatory authorities and agencies Regulatory affairs in the pharmaceutical industry focus on safeguarding human health. People and governments invest in medications due to their crucial role in saving lives, restoring health, preventing diseases, …
Regulatory Approval Process for Investigational New Drug (NDA-24) Investigational New Drug Background Investigational New Drug Investigational New Drug The drug approval process involves a regulatory pathway through which individuals, organizations, sponsors, or innovators obtain permission to introduce a drug into the market. This process typically includes several stages: applying for clinical trial authorization, conducting clinical …
New Drug Discovery and developments-Pharmaceutical regulatory affairs-2024 New Drug Discovery and developments Drug discovery is a complex and multi-step process that involves identifying chemical compounds for potential therapeutic use in treating and managing various diseases. This process encompasses the identification of drug candidates, synthesis, characterization, screening, and efficacy testing through various assays. Once a molecule …
Clarios SpiroSphere® with wireless ECG- FDA clears, simplifying clinical trial data collection. Clarios SpiroSphere The FDA has granted 510(k) clearance for the COR-12 wireless ECG device, now seamlessly integrated with SpiroSphere®. This integration enables sponsors to conduct comprehensive respiratory trials while collecting cardiac safety ECG data using a single device. Clarios FDA-cleared SpiroSphere® integration with …
DSCSA (Drug Supply Chain Security Act): FDA extends on 24 DSCSA tracking rules for small dispensers by two years and allows exemption requests. DSCSA (Drug Supply Chain Security Act): On Wednesday, the US Food and Drug Administration (FDA) announced a two-year extension for small dispensers to comply with the enhanced tracking requirements of the Drug …
Medical device equipment: The report suggests strategies to enhance accessibility and cost-effectiveness of crucial medical device equipment. Medical device equipment Encouraging the local production of vital medical equipment, establishing a reliable logistics network and supplier system with strict quality control measures and certification standards, and implementing appropriate pricing strategies are highlighted as key methods to …