Drugs

ICH Looking to the Future

In its 30^th anniversary report, the International Council for Harmonization (ICH) reviews past successes and then looks to the future in a rapidly changing environment. Presenting what the report calls a “pragmatic vision,” ICH says its guidelines “should enable more streamlined drug development of both innovative and generic/biosimilar medicines with the goal of near-simultaneous development and review in different regions.”

ICH also sees the need for it to evolve to keep pace with rapidly evolving technological, digital, and scientific transformations across the healthcare continuum.

It further sees an increasingly critical need to ensure agility and efficiency in the ICH guideline development process given its expanding membership and its impact on timely decision-making.

Finally, ICH says that in addition to guideline development, it should consider the broader regulatory ecosystem, such as capacity building and implementation, to advance its mission to support increased efficiency in drug development and patient access to medicines.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome