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IPQ Monthly Update, November 2014

In focus are the structure, function and impact of two components of the new Office of Pharmaceutical Quality that will be on the front line of its industry/agency interactions: ● the Office of Program and Regulatory Operations (OPRO), which will play a pivotal role in CMC reviews, and ● the Office of Surveillance, which will be spearheading the agency’s effort to more coherently assess a company’s quality management. Included on the international front are stories on: ● how the Europe-based association APIC is mapping API requirements in emerging countries and working with them to make their processes more effective and user friendly, and ● IPEC’s efforts to narrow the excipient maker/user communication gap on visible particles....

APIC is Mapping API Requirements in Emerging Countries and Working with Them to Create More Transparent, Efficient, and Harmonized Regulatory Processes

The Europe-based Active Pharmaceutical Ingredients Council (APIC) is mapping out the current API registration requirements in emerging countries, defining best practices, and developing strategies for working with the various authorities on creating more transparent, efficient and harmonized regulatory processes....

FDA’s New Office of Program and Regulatory Operations Will Assume Pivotal Role in CMC Review

FDA’s Office of Program and Regulatory Operations (OPRO) – part of the new Office of Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research (CDER) – will be responsible for co-leading and facilitating the review of the quality portions of new and abbreviated new drug applications (NDAs/ANDAs)....

IPQ Monthly Update, October 2014

In focus are: ● the structure/function changes FDA is making to help drive a new pharmaceutical quality regulatory paradigm with closer center/field alignment ● the role that the new Office of Pharmaceutical Quality will play in steering the various significant initiatives that are now in motion, and ● the implementation challenges presented by the new ICH guidelines on elemental impurities (ICH Q3D) and mutagenic impurities (ICH M7), respectively....

Implementation Challenges for ICH’s New M7 Guideline on Mutagenic Impurities Will Present Themselves at Both the Development and Post-Approval Levels

Among the challenges that will present themselves to pharma companies in implementing ICH’s new M7 guideline on mutagenic impurities is the use of quantitative structure-activity relationship [QSAR] predictions in assessing the risks during development and for post-marketing changes....

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....

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....

EMA Dossier Requirements

In early September, EMA issued an updated “Dossier requirements for Centrally Authorised Products (CAPs)” in order to mandate the use of digital submissions and clarify which submission gateway is applicable for different authorities.

Same Level of Safety for Fast versus Slow Approvals in Canada

Research published by the Canadian Health Policy Institute (CHPI) in mid-August finds that while regulatory approvals for new drugs in Europe are faster than in Canada, the rate of discontinuation of new drugs for safety reasons is the same in both jurisdictions. The findings indicate that the added Canadian drug approval delay achieves no extra […]
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