Author: masuuglobal

Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance

Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance In the world of pharmaceutical regulation, ensuring the ongoing safety of medicinal products post-market approval is just as crucial as during their development. One of the most important documents used to monitor and evaluate the safety of a drug after it hits the market… Continue reading Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance

Artwork Divisions in Pharmaceutical Packaging

Artwork Divisions in Pharmaceutical Packaging The pharmaceutical packaging industry is complex, highly regulated, and essential to ensuring the safety and efficacy of products. Artwork divisions are a fundamental part of this process, providing the expertise needed to create packaging that is both compliant and effective. From navigating intricate regulatory requirements to understanding the nuances of… Continue reading Artwork Divisions in Pharmaceutical Packaging

Published
Categorized as Artwork

A Common EU Approach to Data Transparency in Medicine Regulation

A Common EU Approach to Data Transparency in Medicine Regulation The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have released a comprehensive update to their guidance on identifying commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. This revision reaffirms the commitment of regulatory bodies across… Continue reading A Common EU Approach to Data Transparency in Medicine Regulation

Published
Categorized as Regulatory

eCTD Implementation in Tunisia

eCTD IMPLEMENTATION IN TUNISIA The electronic Common Technical Document (eCTD) system for drug submissions is being implemented by Tunisia’s National Agency for Medicines and Health Products (ANMPS). The regulatory process for pharmaceutical products will be digitized starting in January 2025 with the transition to online submissions (eSubmission).

Published
Categorized as eCTD

Overview of MoCRA 2022: Key Provisions and FDA Cosmetic Regulations

Overview of MoCRA 2022: Key Provisions and FDA Cosmetic Regulations A significant increase in the U.S. was achieved through the introduction of several important provisions in the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. The FDA is responsible for regulating cosmetics. Some key aspects of MoCRA include:

FDA FAERS Electronic Submissions for Postmarketing & Premarketing ICSRs

FDA Adverse Event Reporting System (FAERS) Electronic Submissions: To assist industry when making certain regulatory submissions in electronic format to the FDA’s Adverse Event Reporting System (FAERS) database for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

International Recognition of Medical Devices | MHRA

Statement of Policy Intent: International Recognition of Medical Devices The UK Medicines and Healthcare products Regulatory Agency (MHRA) aims to facilitate quicker and more efficient access to medical devices by leveraging the expertise and decision-making processes of international regulatory partners. This initiative will benefit patients by allowing the MHRA to recognize approvals from other regulatory… Continue reading International Recognition of Medical Devices | MHRA

Book a Demo