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News Archive
EMA - August 2021 CTIS Newsletter
17th August 2021CTIS Newsletter released
EMA - Consultation on ICH Guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b
17th August 2021The European Medicines Agency has published for public consultation the ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b.
EMA - PRAC Meeting Highlights 5th August 2021
17th August 2021Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
EMA - updated Question and Answer Document on Combination Products
17th August 2021EMA publishes updated Question and Answer Document on Combination Products
MHRA - Access Consortium strategy launched
17th August 2021MHRA Access Consortium strategy launched
MHRA - Consultation on Early Access to Medicines Scheme (EAMS)
17th August 2021The 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.
MHRA - Freedom of Information responses from the MHRA: 2021
17th August 2021MHRA have released the Freedom of Information (FOI) responses for 2021.
MHRA - Regulator seeks views on innovative medicines manufacture at point of care
17th August 2021MHRA seeks views on innovative medicines manufacture at point of care
MHRA Blog Post - Transfer of analytical methods
17th August 2021Technical transfer of analytical methods, or analytical method transfer (AMT) is a GMP requirement for those involved in contract manufacturing and testing.
EMA - CTIS Handbook on the website
10th August 2021The EMA Clinical Trial Information System (CTIS) Sponsor Handbook is now available on the EMA website.
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