Category: Regulatory

Health Canada’s Mandatory XML Product Monograph Rule Takes Effect July 18, 2025 Change in Filing Requirements for XML PM? Health Canada is making Structured Product Monograph (SPM) submissions in XML format mandatory starting July 18, 2025, for select drug applications. This move is part of Canada’s broader effort to modernize regulatory submissions and improve drug… Continue reading Health Canada’s Mandatory XML Product Monograph Rule Takes Effect July 18, 2025

MHRA’s Decentralised Manufacture Designation – Regulatory Framework An overview of designation criteria, submission steps, and compliance considerations for POC and modular manufacturing

Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials : EMA Initiates Consultation on New Clinical Trial Guidance The European Medicines Agency (EMA) invites public feedback on a new draft guideline focused on including pregnant and breastfeeding populations in clinical trials, addressing critical gaps in medicine safety and efficacy data. The consultation is open until… Continue reading Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials : EMA Initiates Consultation on New Clinical Trial Guidance

Overview of FDA Covered Product Authorization (CPA) and the CREATES Act What is FDA Covered Product Authorization (CPA)? FDA Covered Product Authorization refers to the official approval given by the U.S. Food and Drug Administration (FDA) for certain medical products to be marketed in the United States.

Health Canada Validation Criteria 5.3 – Compliance Update Effective May 31, 2025 As part of our continued commitment to regulatory compliance and operational excellence, we are notifying our clients, partners, and stakeholders about important updates to Health Canada’s Validation Criteria, version 5.3, which will come into effect on May 31, 2025.

Swissmedic Nitrosamine Risk Assessment Requirements Swiss agency updated the guidance on nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents.

Scheduled Maintenance Notice: ESG NextGen Platform Downtime on May 17, 2025

Navigating EMA’s Updated Paediatric Application Procedures: April 2025 Insights On 15 April 2025, the European Medicines Agency (EMA) released an updated version (Rev. 121) of its procedural advice on paediatric applications (EMA/672643/2017). This revision reflects the agency’s commitment to streamlining regulatory processes, enhancing transparency, and supporting innovation in paediatric medicine development across the EU.

Understanding ACA Section 6004: Ensuring Drug Safety and Transparency in Healthcare On March 23, 2010, the Affordable Care Act (ACA) was signed into law. Among other things, the ACA amends the Social Security Act, 42 U.S.C. 1301 et seq., by adding section 6004. This new section requires the submission of certain drug sample information to… Continue reading Understanding ACA Section 6004: Ensuring Drug Safety and Transparency in Healthcare

Risk Evaluation and Mitigation Strategies (REMS) The Food and Drug Administration Amendments Act (FDAAA) of 2007, signed on September 27, 2007, by President George W. Bush, created section 505-1 of the Food, Drug, and Cosmetic Act (FD&C Act) which authorizes FDA to require a Risk Evaluation and Mitigation Strategies (REMS) for certain drugs if FDA… Continue reading Risk Evaluation and Mitigation Strategies (REMS) Overview