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Post meeting Update: FDA's modernizing of pharmaceutical regulatory processes-change to keep pace with new realities, ICH up date

Update: Of interest here is the subject matter characterized as Facilitating Innovation for Better Health Outcomes and how using a QbD approach can help make medicinal drug products be more affordable and safe, recurring themes. The importance of team work was a major focal point; that is, the 21st century FDA regulatory team on a QbD application can include reviewers and inspectors working on new drug applications together with the compliance office in a collaborative rather than in the traditional linear manner.
4 speakers made presentations: speakers for industry perspectives included one from the world's largest research-based pharmaceutical company who shared his perspectives based on early current QbD experiences about a growing business case in favor of the impact QbD can have on product quality in the development/ manufacturing of medicines and the product cycle (but more time yet is needed to make the buisness case for it). A speaker from a leading generic pharmaceutical company presented the generic industry perspectives on QbD. 2 presentations were made from regulatory perspectives (EMA and FDA).
Following are a few general notes on the meeting- but of course they only provide a glimpse of the initiative discussed. The slide presentations and the webcast are best seen first hand if possible.
The Committee's New York voting member (University of Buffalo State University of New York) complimented the EMA-FDA pilot joint effort (a parallel QbD assessment), this pilot should stimulate QbD applications. Updated see (3) below. As presented, the trending business case for pharma includes a value proposition in saving costs associated with making medicines and product cycles by reducing product defects, rejections, investigations, product recalls and risk managing drug products that deviate from expectations and avoiding the costs associated with product variability which requires regulatory investigation. Lower costs can make medicines more affordable. QbD was used in the redesign of an older marketed drug that showed some unexpected variability in performance. Speakers noted that the regulatory role and impact on the review timeline to develop/launch drug products should not be negatively impacted.
The use of Qbd may also result in fewer studies being conducted, less testing being conducted in favor of more modeling as those technologies are further developed. One of the biggest issues needing clarification is an understanding of what science is necessary (versus nice to know) for FDA applications. EMA noted that some applications can contain too many conclusions without showing the story of how they were arrived at. In assessing the value of QbD approaches for the complex area of biotech development, academia may become more involved and perhaps a working group should be created to focus long term. Other Committee members suggested that a Qbd report be made, that a center for sharing resources and technologies to implement QbD approaches for use by smaller drug manufacturers be created. For generic drug manufacturing, using a QbD strategy improving drug quality can be even more meaningful. As one speaker concluded,
QbD works and is here to stay.
More cases using the QbD approach are needed and perhaps even work needs to be done in making cultural transformations to better understand the meaning and impact of such changes in the making of medicine.

See below for pre meeting blog entry.
(1)http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/ucm263466.htm
(2)http://www.ich.org/
Update on FDA int'l pilot projects info :
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm266305.htm


Public briefing materials for the July 27 2011 meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee (to be a continuation of their July 26 meeting) include speaker slides for 2 anticipated presentations, the first is entitled Facilitating Innovation for Better Health Outcomes.(1) The Agenda indicates that the Committee will discuss current strategies for the FDA's Office of Pharmaceutical Science (OPS) implementation of Quality by Design (QbD) principles within its review offices, incorporating an update on the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use activities. FDA's implementation of quality by design is based on a new paradigm for review using high quality pharmaceutical science. Draft q's for the Committee include- How to address technical and regulatory gaps identified by speakers?
Can QbD approaches be valuable for biotech product development? New realities in regulating drug quality include the availability of many more treatments, sources of products and substances worldwide, patients and clinicians need for more accurate , up to date and understanding of information, and new science and technologies that promise accelerating product development and manufacturing capabilities.
In 2010 ICH celebrated 20 years of ground breaking work to harmonize the criteria and documents required for approval and authorization of new medicinal products.(2)

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This page contains a single entry from the blog posted on July 20, 2011 9:57 AM.

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