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ICH Q8-11 Oriented Submission and GMP Expectations for Process Validation and Other Quality Issues Taking Shape in Europe

The effort in Europe to update its expectations for process validation (PV) to reflect the quality management principles underpinning ICH Q8-11 moved closer to completion in late February with the issuance of a final guideline on PV submissions for medicinal products and a draft revision of EU GMP Annex 15....

FDA and EMA Extend QbD Pilot, Plan More QbD Guidance

In early March, FDA and EMA announced a two year extension of their pilot program for collaborative review of QbD applications launched in 2011. FDA and EMA also indicated that additional QbD guidances are expected to be published in 2014. [See IPQ March 27 2014 for more on EMA’s 2014 quality initiatives.]

IPQ Monthly Update, February 2014

In focus are the nexus of problems facing industry and regulators in the global CMC arena. The stories explore: ● the post-approval change constrictions in Japan and how they compare and interface with those globally ● the discussions among a panel of global regulators on expediting reviews, and the implications for the CMC review process ● the impact that the global regulatory maze is having on vaccine suppliers, and ● the challenges the biotech industry faces in making even minor, low-risk changes post-approval, and what needs to be done to address them....

Post-Approval Change Regulatory Burden Draws Heat at Japan Biotech CMC Strategy Forum

Industry associations have been meeting with Japanese regulators to highlight the problems they are experiencing in Japan’s process for regulating post-approval manufacturing changes, including a lack of flexibility around biotech product changes that results in most requiring prior approval as well as meetings with the agency to resolve unclear expectations....

FDA is Working to Expand Question-Based Review Approach From Generic to Innovator Applications

A working group that spans the new drug and generic reviewing offices at FDA’s Center for Drug Evaluation and Research (CDER) is nearing release of a proposed revision of the questions it developed under its question-based review (QbR) approach for generics that is designed to be applied to innovator applications as well....

FDA’s Center for Drugs Redoubles Effort to Achieve 21st Century Quality Vision and Foster Continuous Process Improvement

FDA’s Center for Drug Evaluation and Research (CDER) is wrestling with how to reshape its quality regulatory system to foster rather than impede continuous improvement across the lifecycle of a process....

IPQ Monthly Update — April, 2013

The annual conference of the Food and Drug Law Institute (FDLI), held in downtown Washington in mid-April, again provided an important venue for FDA to deliver a “state of the agency” address on the key legal, legislative and regulatory developments during the previous year and what to expect in the year to come....

ASEAN Adopting QbD Approach to Process Validation Under Singapore Leadership

Singapore is leading an effort by the Association of Southeast Asian Nations (ASEAN) to achieve a harmonized approach to process validation modeled on FDA’s lifecycle approach and the ICH Q8-10 paradigm it embodies....

EMA GMP Chapter Draft Revisions Focus on Current Compliance Focal Points from Shared Facilities to Defect Investigations

The European Medicines Agency (EMA) has released draft revisions of four of its GMP chapters, intended to communicate its expectations regarding current compliance focal points including supply chain oversight, shared facilities, starting materials, lab method transfers, and investigating and reporting quality defects....

Better Glycosylation Understanding Would Further International Biotech Regulatory Convergence Efforts, CMC Strategy Forum Participants Agree

Regulators are highlighting a better understanding of protein glycosylation – its linkage to product safety and efficacy and what constitutes appropriate characterization – as an important element in developing a more internationally-aligned approach to regulating biotech products....
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