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EMA to provide guidance on avoiding nitrosamines in human medicines
EMA to provide guidance on avoiding nitrosamines in human medicines
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EMA to provide guidance on avoiding nitrosamines in human medicines
EMA to provide guidance on avoiding nitrosamines in human medicines
EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances.
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Global meeting on draft ICH guideline on clinical trials
Global meeting on draft ICH guideline on clinical trials
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Global meeting on draft ICH guideline on clinical trials
Global meeting on draft ICH guideline on clinical trials
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is organising a public meeting on 31 October 2019 at the FDA headquarters to review its draft E8 (R1) Guideline ‘General Considerations for Clinical Trials’.
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019
The PRAC starts review of data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis.
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Updated guidance for industry on preparing for Brexit
Updated guidance for industry on preparing for Brexit
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Updated guidance for industry on preparing for Brexit
Updated guidance for industry on preparing for Brexit
EMA and the European Commission provide additional information on exemptions for batch testing to help pharmaceutical companies prepare for the UK’s withdrawal from the EU.
