News Archive

EMA - Artificial intelligence in medicine regulation

17th August 2021

The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published today.

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EMA - August 2021 CTIS Newsletter

17th August 2021

CTIS Newsletter released

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EMA - Consultation on ICH Guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b

17th August 2021

The European Medicines Agency has published for public consultation the ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b.

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EMA - PRAC Meeting Highlights 5th August 2021

17th August 2021

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021

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EMA - updated Question and Answer Document on Combination Products

17th August 2021

EMA publishes updated Question and Answer Document on Combination Products

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MHRA - Access Consortium strategy launched

17th August 2021

MHRA Access Consortium strategy launched

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MHRA - Consultation on Early Access to Medicines Scheme (EAMS)

17th August 2021

The UK Early Access to Medicines Scheme (EAMS) is one of the ways through which a patient with a life threatening or seriously debilitating condition can gain access to a medicine before it has gained approval from the UK’s medicines regulatory authority. The MHRA are seeking your views on the proposed legislative changes to clarify the legal basis for EAMS.

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MHRA - Freedom of Information responses from the MHRA: 2021

17th August 2021

MHRA have released the Freedom of Information (FOI) responses for 2021.

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MHRA - Regulator seeks views on innovative medicines manufacture at point of care

17th August 2021

MHRA seeks views on innovative medicines manufacture at point of care

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MHRA Blog Post - Transfer of analytical methods

17th August 2021

Technical transfer of analytical methods, or analytical method transfer (AMT) is a GMP requirement for those involved in contract manufacturing and testing.

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