CN EN
ICH News

ICH 2020 first half of the guidelines progress and planned new guidelines

Author:Shilin-JiaoDate:2021-03-25From:www.shilinx.com

ICH issued a press release on June 3 to introduce some of the progress of its web conference held on May 27, including the addition of new members and observers, and an update of the guidance process under development. This web conference replaced the conference originally scheduled to be held in Vancouver, Canada. At the meeting, ICH first welcomed the Turkish Medicines and Medical Devices Agency (TITCK) as a regulatory member. TITCK joined ICH as an observer in 2018. In addition, the Lebanese Ministry of Public Health (MOPH) has become a new observer. So far, the total number of ICH members has reached 17 and there are 32 observers.

ICH will start to develop patient-centered drug development guidelines

Author:Shilin-JiaoDate:2021-03-23From:www.shilinx.com

ICH is seeking feedback on the development of a globally uniform method guide for collecting patient opinions and incorporating them into the drug development and regulatory process, including the development of a new uniform guideline for collecting patient opinions in a reasonable and sustainable method for industry and regulatory agencies.

eCTD v4.0 Q&A v.1.4 Reach step 4 of the ICH process

Author:ICHDate:2021-03-23From:ICH Official website

eCTD v4.0 Questions and Answers (Q&A) and Specification Change Request document v1.4 reached Step 4 of the ICH process in December 2020.
Back to top