Staying ahead in the pharmaceutical industry means keeping pace with evolving regulations. EMA and CMDh updates can impact compliance, approvals, and market access. At Pharmexon Consulting, we don’t just track these changes—we turn them into actionable insights to help you stay compliant and competitive.
Explore this month’s critical regulatory updates and their implications for your business.
· Product Management Service (PMS) – FAQs Update
The EMA has updated its Product Management Service (PMS) FAQ document, providing clarification on various regulatory procedures. Companies should review the changes to ensure compliance with new expectations.
· Specification Requirements for Biological Products
EMA has updated the requirements for specifications of biological products. The key update requires unequivocal identifiers, determined by the manufacturer, to be present in the specifications for Drug Product (DP) and Drug Substance (DS) for biologicals.
· GMP Inspections for Centrally Authorised Products
The EMA has published a new document outlining the coordination of Good Manufacturing Practice (GMP) inspections for centrally authorised products. This new guidance came into force on January 1, 2025 and clarifies inspection procedures for regulatory compliance.
· Post-Authorisation Guidance Update
The EMA has updated its post-authorisation procedural guidance. The major updates focus on:
- Fee changes affecting regulatory submissions.
- Introduction of track changes versions for product information documents.
· Post-Authorisation Biosimilars Guidance Update
A similar update applies to biosimilars, as detailed in this EMA guidance document. Companies working with biosimilars should take note of these updates, particularly regarding safety variations.
· CMDh December Meeting Report
The latest CMDh meeting report covers key discussions from the December 10-11, 2024 meeting. The focus was on the transition of EMA post-authorisation procedures to the IRIS platform, which is crucial for stakeholders like Stelis.
PRAC Meeting Updates and Guidelines
· PRAC Meeting Minutes
The PRAC meeting minutes from October 28-31, 2024, highlight key discussions on pharmacovigilance updates and risk assessment strategies.
· List of LCPPV Requirements
The updated list of LCPPV requirements includes changes for Estonia, affecting Risk Minimisation Measures (RMMs).
· PRAC Work Plan 2025
The PRAC Work Plan outlines upcoming activities and priorities for the year.
· PRAC Meeting Highlights – January 2025
The draft agenda for the upcoming PRAC meeting on January 13-16, 2025 has been released. Key topics include updates on adverse reaction monitoring and risk minimisation strategies.
· Specific Adverse Reaction Follow-Up Questionnaires (AR FUQ) Guideline
A new guideline on specific adverse reaction follow-up questionnaires will take effect on February 1, 2025. Companies should ensure compliance with the updated requirements.
These updates reflect the latest changes in regulatory procedures and requirements, ensuring compliance across the pharmaceutical industry.
At Pharmexon we go beyond traditional consultancy—offering dynamic regulatory intelligence that keeps you ahead of industry shifts.
With multi-dimensional expertise, global reach, and a solutions-driven approach, our team of former regulators and industry professionals ensures you receive proactive insights and strategic guidance at every stage of the product lifecycle.
Need expert regulatory intelligence to stay compliant and competitive? Reach out to our team today and let’s navigate the evolving regulatory landscape together.
