Pharmaceuticals Regulatory Updates

Stay up to date with Regulatory Updates from the pharmecutical industry with our regular bulletins, updates and insights.

Streamlining Post-Authorization Changes: Key Updates to the EU Pharmaceutical Variation Guidelines

Streamlining Post-Authorization Changes: Key Updates to the EU Pharmaceutical Variation Guidelines

Shilpam Rajput2024-09-18T14:37:34+00:00June 20th, 2024|

An Assessment of the EU Parliament Amendments to the Commission Proposal of the EU Pharma Package

An Assessment of the EU Parliament Amendments to the Commission Proposal of the EU Pharma Package

Shilpam Rajput2024-09-18T14:37:35+00:00May 15th, 2024|

FDA Guidance: Navigating Annual Reportable Labeling Changes for Nonprescription Drug Products

FDA Guidance: Navigating Annual Reportable Labeling Changes for Nonprescription Drug Products

Celegence2024-04-25T11:18:28+00:00April 8th, 2024|

EU Clinical Trials to be Transitioned to the New CTIS Portal by January 2025

EU Clinical Trials to be Transitioned to the New CTIS Portal by January 2025

Celegence2024-02-21T08:31:11+00:00January 17th, 2024|

EMA Update on On-site GMP and GDP Inspections Approach for 2024

EMA Update on On-site GMP and GDP Inspections Approach for 2024

Celegence2024-04-25T11:16:37+00:00December 13th, 2023|

An Inside Look: The European Commission Publishes the First Union List of Critical Medicines

An Inside Look: The European Commission Publishes the First Union List of Critical Medicines

Celegence2024-02-21T08:24:07+00:00December 13th, 2023|

FDA Proposes Benefit-Risk Assessment Guidance for New Drug and Biological Products

FDA Proposes Benefit-Risk Assessment Guidance for New Drug and Biological Products

Celegence2024-02-21T08:21:30+00:00November 20th, 2023|

FDA Issues Guidance for Industry on Biosimilar Labeling

FDA Issues Guidance for Industry on Biosimilar Labeling

Celegence2024-04-25T11:17:33+00:00November 2nd, 2023|

FDA Finalizes Guidelines on Dose Banding for Ready-to-Use Containers

FDA Finalizes Guidelines on Dose Banding for Ready-to-Use Containers

Celegence2024-02-21T07:46:36+00:00October 31st, 2023|

Pharmaceuticals Regulatory Updates

Streamlining Post-Authorization Changes: Key Updates to the EU Pharmaceutical Variation Guidelines

Streamlining Post-Authorization Changes: Key Updates to the EU Pharmaceutical Variation Guidelines

An Assessment of the EU Parliament Amendments to the Commission Proposal of the EU Pharma Package

An Assessment of the EU Parliament Amendments to the Commission Proposal of the EU Pharma Package

FDA Guidance: Navigating Annual Reportable Labeling Changes for Nonprescription Drug Products

FDA Guidance: Navigating Annual Reportable Labeling Changes for Nonprescription Drug Products

EU Clinical Trials to be Transitioned to the New CTIS Portal by January 2025

EU Clinical Trials to be Transitioned to the New CTIS Portal by January 2025

EMA Update on On-site GMP and GDP Inspections Approach for 2024

EMA Update on On-site GMP and GDP Inspections Approach for 2024

An Inside Look: The European Commission Publishes the First Union List of Critical Medicines

An Inside Look: The European Commission Publishes the First Union List of Critical Medicines

FDA Proposes Benefit-Risk Assessment Guidance for New Drug and Biological Products

FDA Proposes Benefit-Risk Assessment Guidance for New Drug and Biological Products

FDA Issues Guidance for Industry on Biosimilar Labeling

FDA Issues Guidance for Industry on Biosimilar Labeling

FDA Finalizes Guidelines on Dose Banding for Ready-to-Use Containers

FDA Finalizes Guidelines on Dose Banding for Ready-to-Use Containers

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