ICH Project ICH Q7 Active Pharmaceutical Ingredients (API) GMP Q&A Briefing

April 26, 2016

With the aim of facilitating simultaneous global development of pharmaceuticals and ensuring international drug safety, as well as harmonizing pharmaceutical regulations among Japan, the U.S., and Europe, active discussions have been held within the ICH framework, and significant progress has already been made.
The Q&A for ICH Q7 (Active Pharmaceutical Ingredients GMP) reached Step 4 on June 10 of last year and was published on the official ICH website.
Active Pharmaceutical Ingredient (API) GMP reached Step 4 in November 2000,and was issued as a domestic notification in November 2001. More than 10 years have passed since then, and through its implementation to date, the guidelines were reviewed to clarify ambiguous points in the interpretation of the Active Pharmaceutical Ingredients (API) GMP guidelines and to incorporate new interpretations of the concepts covered in Q8 through Q11.
In light of the domestic issuance of the Q7 Q&A, we held a briefing session on its contents.

Over 320 industry representatives attended this briefing, and a lively question-and-answer session took place, demonstrating the high level of interest among participants.
The program, presentation schedule, and presentation materials for this briefing are attached below and can be viewed directly. Please note that unauthorized copying or reproduction of the attached materials posted on this website is prohibited.

Date, Time, and Venue

Information and Program

Event Notice and Program (276KB)

Lecture Materials

　

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