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

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 also updated the progress of four existing guidelines at the meeting, three of which have entered phase 4 in recent months, and one has entered phase 2. The guidelines for entering Phase 4 include:

· ICH M8 Electronic Common Technical Document (eCTD) v4.0 Guidelines Question and Answer Document v1.3

· ICH's new S11 supports non-clinical safety trials for pediatric drug development [ICH releases S11 to promote pediatric trials and reduce animal use 2020/04/18]

· ICH S5(R3) Detection of Reproductive Toxicity and Developmental Toxicity of Human Drugs [ICH Publishes Reproductive Toxicity and Developmental Toxicity Testing Guidelines 2020/02/28]

The "Q3C(R8) Impurities: Guidelines for Residual Solvents", which contains three new impurity exposures per day, entered the second phase in March. The Chinese Drug Evaluation Center has also issued a Chinese translation at the end of April and solicited public comments. The conference also expressed support for work on two new topics, including: revision of M4Q (R1) Common Technical Document (CTD) guidelines and structured product quality submission. The work of M4Q(R1) CTD is expected to start after an informal working group is established at the end of 2020, and plans to initiate a drafting plan for structured product quality submission, because this topic is complementary to the work of M4Q(R1) CTD . In addition, the conference also expressed support for the establishment of discussion groups to further consider the scope and methods of possible new coordination activities related to the following two thematic proposals: Model-Informed drug development to support drug registration; and ICH E4: Support drugs The amount-effect relationship information required for registration.

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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.
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