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The ICH Q3D(R1) Guideline for Elemental Impurities reached Step 4 of the ICH Process in March 2019 and now enters into the implementation period (Step 5).
The ICH M10 draft Guideline on Bioanalytical Method Validation reached Step 2b of the ICH Process on the 26 February 2019 and now enters the consultation period.
In November 2018, the ICH Management Committee met in Charlotte, NC, USA for their bi-annual meeting.
The ICH Reflection Paper on Further Opportunities for Harmonization of Standards for Generic Drugs was endorsed by the ICH Assembly in November 2018.
In November 2018, the ICH Assembly met in Charlotte, NC, USA for their bi-annual meeting. Minutes from this meeting are made publicly available.
The International Council for Harmonisation (ICH) met in Charlotte, NC, USA on 10-15 November 2018.
The MedDRA Management Committee noted that 1 March 2019 will mark the 20 year anniversary of the first release of MedDRA.
The International Council for Harmonisation (ICH) met in Charlotte, NC, USA on 10-15 November 2018.