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Team-Based Quality Assessment Approach Among Key Changes Underway as CDER’s Office of Pharmaceutical Quality Comes to Life

FDA’s Center for Drug Evaluation and Research (CDER) is finding that its new “team-based integrated quality assessment” model makes the review process more efficient and effective, and the model is winning the praise of team members involved....

ICH Q3D Could Provide Model for More Inclusive ICH Process; Focus Continues on Q3D Implementation Challenges, Including Risk Assessments

The development and implementation of the ICH Q3D guideline on elemental impurities could provide a model for a more inclusive ICH process....

IPEC Library of Nanotech Information

IPEC-Americas has made available to its members a “Library of Nanotechnology Information.” The library contains articles on safety/toxicology and regulatory information regarding nanotech. IPEC, in turn, asked its membership for feedback on: acceptable uses of nanomaterials, physicochemical properties used in describing nanomaterials, toxicity concerns, safety of human exposure, and descriptions of the regulatory environment for […]

Guideline on Regulatory Acceptance of 3R testing

EMA issued a draft guideline on regulatory acceptance of 3R (replacement, reduction, refinement) for use in animal testing approaches. The guideline describes the submission and evaluation process for 3R testing for drug development and production related to non-clinical/safety testing and batch control.

Monthly Update, August-September 2014

In focus are: ● a significant proposal from prominent industry experts on revising the CMC submission paradigm to help spur transparency, QbD and continuous improvement, along with FDA reviewer comments on the proposal ● a series of new FDA guidances and an EU initiative on the generic drug review process ● Amgen’s MS-based “multi-attribute methodology” initiative to streamline biotech development and QC, and ● the Rx-360 keys to a strong supply oversight program and how Amgen is applying them....

New CMC Submission Approach Needed to Foster Transparency and Continuous Improvement, PhRMA Team Says; Embedding Control Strategy as Regulatory Commitment in QOS Proposed

A working group of prominent CMC experts across the member companies of the Pharmaceutical Research and Manufacturers of America (PhRMA) has formulated a proposal for a more performance and risk-based regulatory approach to CMC submissions that would better accommodate post-approval manufacturing and control improvements....

EDQM CEP Form Updates

The application forms for requesting certificates of suitability (CEPs) were updated in late September to reflect recent changes to the EDQM guideline on the requirements for revision/renewal of CEPs to the European Pharmacopeia Monograph, issued in July 2014, as well as invoicing changes. These forms are meant to be used for applications submitted from October […]

China and Taiwan Mutually Recognize Inspections

Chinese and Taiwanese Health Officials have agreed to cooperate on clinical trial regulation and to mutually recognize drug inspections.

PDA Post-Approval Change Harmonization Initiative

In mid-September, PDA announced that it was forming a task force to work on harmonizing global post-approval change protocols for typical manufacturing changes and providing a template for post-approval change management. [For a review of a PhARMA proposal for a new approach to CMC submissions approach that would better accommodate postapproval changes see IPQ October […]

FDA ANDA Refuse-to-Receive Guidance Finalized

In mid-September, FDA issued the final version of its “Refuse-to-Receive Standards” guidance and a draft guidance on “Refuse-to-Receive for Lack of Proper Justification of Impurity Limits”. FDA had issued a draft RTR standards guidance in October 2013. Changes made included: ● clarification of the definitions of “major” and “minor” deficiencies ● the remedy process and […]
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