The News in Depth
The procedures, eligibilities and goals of EMA’s accelerated access approaches for new medicines that fill unmet medical needs, including “Priority Medicines” (PRIME) and “Adaptive Pathways” (AP), have been taking more concrete shape, informed by the European agency’s growing implementation experience.
In focus are the active discussions now going on between industry and regulators on: ● the role that knowledge management can play in evolving the lifecycle quality regulatory paradigm ● how to make the agency’s inactive ingredient database (IID) as accurate and useful as possible, and ● how regulators are refining their expectations and guidance around data integrity based on their inspection experience, and what companies should be doing, in turn, to uncover, fix, and prevent data integrity problems.
August 25, 2016 | Posted in The News in Depth
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FDA’s Office of Pharmaceutical Quality (OPQ) is sharpening its vision of how to increase the reliability and user input in its Inactive Ingredient Database (IID) to make it more beneficial to both internal and external users.
U.S. and European regulators are giving a clear message at public meetings and in their written guidance that up-front communication with the agencies about data integrity lapses that a company has uncovered is critical to maintaining trust and avoiding more serious enforcement repercussions later.
The number and depth of comments FDA received on its new draft data integrity (DI) guidance, and the dialogue the guidance has generated at recent public forums, indicate the high profile nature, dimension, and complexity of the challenges regulators face in overseeing and seeking to advance industry DI practices.
Guidances issued between April and July 2016 by FDA, UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), and the World Health Organization (WHO) are providing a stronger foundation for the industry/regulator dialogue around the world on where the current gaps are in industry’s oversight of data integrity (DI) and how those gaps should be filled.
The focus has been intensifying at industry/regulator forums on how to evolve knowledge management programs, on the one hand, and the quality regulatory paradigm, on the other, to better support the goal of continuous improvement across the product lifecycle.
In this Update, IPQ explores the complexities and challenges in both the downstream and upstream dimensions of the pharma supply chain. Downstream the IPQ focus continues on the ongoing FDA/industry efforts to implement a comprehensive track & trace system for RX drugs in the US: ● the first story, from the vantage point of FDA and pharma manufacturers ● and the second from that of the wholesalers and distributors. The issue then moves upstream to focus on: ● the divergent ways in which excipients are regulated by agencies around the world ● and how the biotech industry is cooperating to better control the raw materials needed to process and formulate its products.
June 27, 2016 | Posted in The News in Depth
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An analysis of the way excipients are handled by regulators around the world reveals significant differences in the registration/licensing and GMP requirements as well as both the form and content of what needs to be submitted to support drug applications.
The biopharmaceutical industry is working collaboratively to expand its ability to control the quality of the wide variety of raw materials that are being used in production and formulation through improved communications across the increasingly complex supply chains involved.
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IPQ is dedicated to helping advance the dialogue on evolving and harmonizing the regulation of pharmaceutical and biologic quality and manufacturing.
IPQ takes its readers from:
- ● the headlines to the forces driving them
- ● regulations and policies to their underlying intent
- ● the pieces of the puzzle to their interconnection
- ● requirements to implementation pathways
- ● random data to critical trends
- ● the sidelines to helping shape the outcome
- ● compliance problems to proactive quality tools
- ● information to intelligence
Subscribe today and get 24/7 access to the IPQ family of publications: “In the News” — breaking stories on our website; “Weekly News Alert” — sent via email; “Monthly Update” — the key CMC and GMP developments in the US, Europe and internationally; “Special Reports” — in-depth analysis of specific, emerging issues of regulator/industry concern; and Documents and Archives — live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library.