The implementation of the ICH GCP guideline is scheduled for July by EMA. The International Council for Harmonization guidelines on Good Clinical Practices will be brought into effect by the European Medicines Agency on July 23, 2025.
Author: masuuglobal
AU-TGA eCTD Submission Updates
AU-TGA eCTD Submission Updates: TGA has announced updates to Module 1 & Regional Information to the specifications and technical validation criteria transitioning from eCTD AU Module-1 v3.1 to v3.2.
How AI Will Help the Pharmaceutical Industry
How AI Will Help the Pharmaceutical Industry: The pharmaceutical industry is one of the most complex and regulated sectors in the world. However, with the rise of artificial intelligence (AI), there’s an incredible opportunity to accelerate processes, lower costs, and ultimately improve patient outcomes. AI is transforming various aspects of the pharmaceutical sector, from drug… Continue reading How AI Will Help the Pharmaceutical Industry
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
Increasing the EDQM’s global impact: Brazilian health authority to rely on CEP evaluation procedure
Increasing the EDQM’s global impact: Brazilian health authority to rely on CEP evaluation procedure Brazil Regulatory Body ANVISA recognizes CEPs: EDQM website newsroom announced that the Brazilian health authority ANVISA has started to recognize evaluation reports and docum1ents from other authorities as a part of its assessments.
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
Changes to the Selection of RMPs for UK Marketing Authorisations from January 2025
Selection of Reference Medicinal Products (RMPs) for the UK Starting from 1 January 2025, there will be legislative changes affecting the selection of Reference Medicinal Products (RMPs) used to support abridged applications for UK-wide marketing authorisations.
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).
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: