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EC proposes downgrading of variation classification for quality changes

EC proposes downgrading of variation classification for quality changes

by Jennifer Murphy | Nov 10, 2024 | Acorn Regulatory News, Biologics

The current Variations Regulation, i.e. Commission Regulation (EC) No.1234/2008, was introduced in 2008 with the aim to simplify and introduce more flexibility to the process of post-approval changes to marketing authorisations (MA). A successful variations system...
Revision 2 of ICH Guideline on viral safety evaluation ICH Q5A

Revision 2 of ICH Guideline on viral safety evaluation ICH Q5A

by Jennifer Murphy | Oct 29, 2024 | Acorn Regulatory News, Biologics

Revision 2 of ICH Q5A Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin comes into effect Virus contamination is a major concern for the manufacture of biotechnology products. While products derived from...
New ICH Q2(R2) and ICH Q14 Analytical Procedure Guidelines released

New ICH Q2(R2) and ICH Q14 Analytical Procedure Guidelines released

by Jennifer Murphy | Oct 22, 2024 | Acorn Regulatory News, Pharmaceutical

The ICH Q2 Guideline on the validation of analytical procedures applies to the analytical procedures used for release and stability testing of commercial drug substances and products. ICH Q2 has been in existence since 1993, with ICH Q2(R1)  coming into effect in...
Italian Transition to EU Falsified Medicines Directive Compliance – Update

Italian Transition to EU Falsified Medicines Directive Compliance – Update

by Jennifer Murphy | Oct 21, 2024 | Acorn Regulatory News

9th February 2025 is the deadline for full implementation of the EU Falsified Medicines legislation (Directive 2011/62/EU and EU Delegated Regulation 2016/161) at a national level in Italy. The law outlining the steps towards the Italian national implementation of the...
Shortlisted for a Pharma Industry Award

Shortlisted for a Pharma Industry Award

by Jennifer Murphy | Sep 3, 2024 | Acorn Regulatory News

We are thrilled that our Regulatory Team was shortlisted for a Pharma Industry Awards -Pharma Contract Services Company of the Year 2024. Our nomination is for their excellent work on implementing a client Regulatory Information Management (RIM) System.
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