News Archive

EMA - Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines

2nd February 2023

EMA, the European Commission and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), are closely monitoring and responding to current shortages of antibiotics affecting the EU. Shortages of medicines have been an ongoing public health concern and the situation in the EU has been exacerbated by geopolitical events or trends such as the war in Ukraine, the energy crisis and high inflation rates.

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023

2nd February 2023

EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 17-18 January 2023

2nd February 2023

EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 17-18 January 2023

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EMA - Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU

2nd February 2023

Use of CTIS becomes mandatory for new clinical trial applications in the EU

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EMA - update on shortages of antibiotics in the EU

2nd February 2023

EMA - update on shortages of antibiotics in the EU EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next steps in the coordinated response to the ongoing shortages of antibiotic medicines containing amoxicillin (alone and in combination with clavulanic acid) in the EU. The MSSG is made up of representatives from EMA, the European Commission and the Heads of Medicines Agencies (HMA).

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FDA - Dosage and Administration Section of Labelling for Human Prescription Drug and Biological Products — Content and Format

2nd February 2023

Dosage and Administration Section of Labelling for Human Prescription Drug and Biological Products — Content and Format Open for Comment

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FDA - Format and Content of a REMS Document Guidance for Industry for Comment

2nd February 2023

Open for Comment

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ICH - ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process.

2nd February 2023

The ICH Secretariat is pleased to announce that as of 17 January 2023, the updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process.

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