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ICH News

Сообщение News » 11 окт 2014 23:37

ICH: Report of ICH Steering Committee

A comprehensive report of the last ICH meeting, which was held in Minneapolis, MN, USA, on 4-5 June 2014, is now available on the ICH website under the SC Reports page.
This report outlines the main decisions taken by the ICH Governing Body including feedback from discussions of the MedDRA Management Board and discussion during the Global Cooperation session. The report summarises also the main progress made by each ICH technical working groups (IWGs) since the last meeting in November 2013.
Q7 IWG: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
The Rapporteur reported to the SC on the outcome of the Q7 IWG meeting held in Minneapolis on and progress made in the development of the ICH Q7 Q&A document. The SC noted that the IWG collected comments from constituencies on the first set of 23 Q&As and anticipated to review the feedback received after the Minneapolis meeting.The first set of draft Q&As is expected to be finalised by the end of September 2014.
A second set of draft Q&As would be reviewed by the constituencies of each party by the end of June 2014 during four months. Based on feedback received, the group proposed to the SC that the Q&As could go directly to Step 4 without the need of regional consultation.
It was noted that the group was expecting to finalise its work on the ICH Q&As by the end of June 2015.

Sergey
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ICH Q13 and Q14

Сообщение Sergey » 05 авг 2018 22:40

ICH Prepares for Future Topics

The ICH (International Council for Harmonisation) met in Kobe, Japan, from June 2 – 7, 2018. The corresponding press release provides insight on the topics discussed.


Two announcements have to be highlighted for the area of GMP. The Assembly agreed to begin work on two harmonising guidelines Q13 and Q14 to

Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14), and on
Continuous manufacturing (Q13)
Work will start with developing formal concept papers and work plans.

The Assembly also discussed future strategic areas for harmonisation by endorsing a strategic reflection paper entitled Advancing Biopharmaceutical Quality Standards to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches.

Also the number of Council members is constantly increasing. There are now 16 ICH Members and 27 observers on board:
• CFDA, China, HSA, Singapore and MFDS, South Korea join the current standing members
• BIO and IGBA join the current industry members
• TFDA (Chinese Taipei) becomes a new regulatory member.
• Moldavia (MMD), Malaysia (NPRA), Armenia and TITCK (Turkey) are new observers


The next ICH meeting takes place on 10-15 November 2018 in Charlotte, NC, USA.

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