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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2019
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2019
The PRAC starts a new review of the meningioma risk with cyproterone medicines and recommends new measures to avoid dosing errors with methotrexate.
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EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers
EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers
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EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers
EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers
The European Union and the United States have now fully implemented the Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories.
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Call for all sponsors to publish clinical trial results in EU database
Call for all sponsors to publish clinical trial results in EU database
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Call for all sponsors to publish clinical trial results in EU database
Call for all sponsors to publish clinical trial results in EU database
The European Commission, EMA and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the EU of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT).
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Quality requirements for medical devices in combination products: guideline open for public consultation
Quality requirements for medical devices in combination products: guideline open for public consultation
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Quality requirements for medical devices in combination products: guideline open for public consultation
Quality requirements for medical devices in combination products: guideline open for public consultation
The guideline covers human medicines that include a medical device, known as drug-device combinations. Comments on the guideline can be submitted until 31 August 2019.
