Category: Regulatory

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.

Understanding the Structured Product Monograph (SPM) for Health Canada Submissions The Structured Product Monograph is submitted to Health Canada when you are seeking approval to market a new drug or health product in Canada. Health Canada reviews the SPM to ensure the product is compliant with the Food and Drugs Act and related regulations. It’s… Continue reading Understanding the Structured Product Monograph (SPM) for Health Canada Submissions

CADIFA Manual for Administrative Procedures: The updated CADIFA Manual for Administrative Procedures by ANVISA was published in February 2025 and is available in Portuguese and English on the agency’s website.

EMA Seeks Feedback on Approaches to Qualifying Novel, Non-Mutagenic Impurities – Europe The European Medicines Agency (EMA) has started a discussion about how to qualify novel impurities based on principles and methods.

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.

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 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

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.

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA: The purpose of this guidance is to provide recommendations for abbreviated new drug applications (ANDAs) or Prior Approval Supplements (PAS) to holders of Type II active pharmaceutical ingredient (API)… Continue reading Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry Appropriate Matter for a Request for Reconsideration? Refuse-to-receive decision Tentative approval letter