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Cell/Gene/Tissue Therapy Classification System on Regulatory Front Burner in Europe as Advanced Therapy Wave Builds Globally

As the wave of highly diverse cell/tissue/gene therapies under development continues to build globally, establishing a viable and mutually agreed upon classification system has become a top regulatory priority....

IPQ Monthly Update, January/February 2015

During January and February, IPQ explored several impactful initiatives that are underway in different areas of the pharmaceutical manufacturing and control arena to create standards and databases that will make both industry and regulators more effective and allow them to communicate better.  These include the efforts of: ● the industry-driven Allotrope Foundation to create lab data standards and the “lab of the future”● FDA in cooperation with industry to continue to implement the 2013 Drug Supply Chain Security Act ● regulators, industry and academia to upgrade pharmaceutical excipient databases, and ● Asian regulators, in line with those in the US and Europe, to address a new generation of regulatory challenges....

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....

Allotrope Analytical Lab Data Standardization Effort Gaining Momentum with Better Analytical and Control Processes at Stake

The industry-based Allotrope Foundation is picking up momentum in its ambitious effort to create a framework for standardizing and sharing lab data, with more effective analytical and manufacturing control processes at stake....

Allotrope’s Vision of the Laboratory of the Future Aligns Closely with FDA’s Regulatory Objectives, Senior Industry Players Maintain

The effort of the Allotrope Foundation to create a common lab data format that is instrument and vendor “agnostic,” allowing for more efficient and compliant analytical and manufacturing control processes, aligns closely with FDA’s lab regulatory objectives, senior industry players involved are stressing....

Comment Review, Public Meetings, Supply Chain Pilot to Follow 2014 Bolus of FDA DQSA Track & Trace Guidances

In the wake of having issued a series of guidances in the latter part of 2014 to enable implementation of the 2013 Drug Supply Chain Security Act (DSCSA), FDA is now concentrating on: ● reviewing the comments and finalizing the guidances ● issuing required regulations ● scheduling public meetings ● performing a supply chain pilot program, and ● developing a licensing program for the various trading partners in the supply chain....

IPQ’s Most-Read Stories of 2014

As a retrospective on 2014, IPQ is providing the two stories that generated the largest readership during the year (available in full to non-subscribers as well as subscribers).

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....

FDA’s Center for Veterinary Medicine Using QbR and Other CDER-Tested Approaches to Decrease Review Times; CVM User Fees Drive Guidance Development

The use by FDA’s Center for Veterinary Medicine (CVM) of a question-based review (QbR) approach in CMC submissions over the past three years has resulted in significantly decreased review times for both new and abbreviated new animal drug applications (NADAs and ANADAs) for multiple dosage forms, including sterile products – in many cases with the reviews accomplished in a single cycle....
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