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.
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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:
Regulatory update EU eCTD Validation Criteria
Updated EU M1 eCTD Specification The EU eCTD Module 1 Specification has been updated to v3.1. EU M1 eCTD Specification v3.1 – Updated Guidelines: Release notes with practical information on changes are provided below. There are also changes to the DTD in this version (version 3.1), and the validation criteria was updated to v8.0… Continue reading Regulatory update EU eCTD Validation Criteria
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
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 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
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