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IPQ Monthly Update — November/December 2015 in Review

With the ICH Q12 initiative operating as a catalyst, the dialogue has been intensifying on what is needed to make quality regulatory processes across the product lifecycle more coherent, efficient, process improvement and product supply friendly, and internationally harmonized. This IPQ Monthly Update departs from the usual format to provide a series of stories exploring the various dimensions of the lifecycle management regulatory challenge and the international effort to better address it....

IPQ Monthly Update, June 2015

In focus are: ● FDA’s CDER on the role of the control strategy in application approval recommendations and the challenges reviewers face in piecing the story together ● the key role a novel excipient played in the development of a new insulin inhalation product and the broader implications of the experience, and ● ICH’s effort to address the pressing questions on API CMC and GMP through Q&As on Q7 and Q11....

ICH’s API Coverage Deepening with a Newly Released Q&A on Q7 and a Q11 Q&A Project on Starting Materials Underway

A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide....

FDA CMC Reviewer Recommendations for New Drug Approval Depend on Control Strategy Understanding, CDER is Stressing

CDER is stressing that a clear picture of the control strategy is pivotal for CMC reviewers to make a meaningful application approval recommendation and meet the shrinking timelines under which they are operating....

EMA Guide on ICH Q3D Implementation for Existing Products

EMA issued an implementation guide for the ICH Q3D guideline on elemental impurities in late February. Europe’s two-page guide focuses on implementation issues for existing products and lists the classes of elemental impurities. [For a detailed look at ICH Q3D implementation see IPQ October 23, 2014.]

Asian Agencies Report on Progress in Addressing Emerging Regulatory Challenges at CASSS Biotech CMC Strategy Forum in Japan

Asian medicines agencies are joining those in the US and Europe in seeking to address the emerging regulatory challenges posed by: ● new classes of products such as cell-based regenerative medicines and engineered antibodies ● accelerated approval pathways ● biosimilars ● international convergence, and ● validation lifecycle management....

EMA Guideline on Elemental Impurities

EMA announced that ICH’s Q3D guideline on elemental impurities will come into effect in June 2016 for new applications and December 2017 for products that have already been authorized.

USP Elemental Impurities Timeline

In mid-January, USP announced January 1, 2018 as the date of applicability for its chapters <232> and <2332> on elemental impurities. The new date is in alignment with the implementation date for ICH’s elemental impurities guideline Q3D. [Implementation of ICH Q3D is addressed in IPQ October 23 2014.]

Global Excipient Databases Are Advancing That Will Fill Content and Functionality Gaps in Existing Regulatory Efforts and Further Industry/Regulator Communication

FDA is working with industry, academia, and other regulators globally on major information management initiatives intended to help industry and regulators communicate about pharmaceutical excipients and fill gaps in existing regulatory database efforts, such as the agency’s Inactive Ingredients Database (IID)....

IPQ Monthly Update, December 2014

Headlining IPQ’s international coverage in December is the ICH Q12 effort to identify the constraints in the current quality regulatory paradigm to innovation and continual improvement across the product lifecycle and how it can be adjusted to remove them. Also in focus in the December issue are the structural and functional changes FDA is making to its center and field operations to address these constraints....
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