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The News in Depth

Vertex Sheds Light on Continuous Manufacturing Approval and Post-Approval Challenges

The detection and segregation of non-conforming materials and the justification of sampling plans and locations will be key regulator concerns in reviewing the control system for continuous manufacturing (CM) operations, Vertex is advising based on its experience as the first company to have gone through the CM clearance process at FDA.

IPQ Monthly Update – February / March 2017 in Review

The issue begins with a story on FDA’s broad-based effort to strengthen the governance, process and outreach aspects of its handling of combination products. Also in focus is the intensive dialogue that is happening around continuous manufacturing. Addressed in separate stories are: ● FDA insights from its growing CM experience, and ● the challenges of assuring excipient viability for CM.

Continuous Manufacturing is Driving More Focus on Excipient Fitness for Purpose

The deployment of continuous manufacturing (CM) is prompting the pharmaceutical industry to understand better the characteristics of the excipients they are using and work more closely with suppliers to assure that the materials are fit for purpose. CM is also prompting a harder look at how to open up the clearance pathway for new/modified excipients […]

CDER Offering More Concrete Advice on Continuous Manufacturing as Experience Grows

FDA’s Office of Pharmaceutical Quality (OPQ) has gained enough experience in interacting with industry on implementing continuous manufacturing (CM) operations to be able to offer more concrete advice on the considerations that warrant extra attention.

FDA’s Broad-Based Effort to “Modernize” Combination Product Regulatory Process in Full Swing

FDA’s broad-based effort to “modernize” its regulatory process for products that contain some combination of drugs, biologics and devices gained significant momentum during 2016, and the impact of the effort will continue to increase as 2017 progresses.

IPQ Monthly Update – January 2017 in Review

During January, IPQ’s attention turned to the potential that international cooperation offers as regulatory agencies move down the pathway from information sharing to mutual recognition. ● The first story focuses on WHO’s role in regulatory capacity building in the biotherapeutics arena. ● The second story provides more on the other key organizations involved in advancing the medicinal quality regulatory process internationally – how they interrelate, what they are trying to accomplish, and the progress they are making.

International Regulatory Initiatives Guide Agencies Down Info-Sharing/Reliance/Recognition Pathway; ICMRA Targets Initiative Coordination

A mapping of the complex web of organizations and initiatives through which regulators around the world are now interacting is a first step in the mission of the International Coalition of Medicines Regulatory Authorities (ICMRA) to better coordinate resources in addressing global challenges.

Strengthening Biotherapeutic Regulation Worldwide Will Remain a High Priority for WHO in 2017

Strengthening the capacity of governments around the world to regulate biotherapeutics and biosimilars in the effort to increase patient access to high quality products will remain a key priority for the World Health Organization (WHO) in 2017.

IPQ Monthly Update – December 2016 in Review

During December, IPQ explored how the increasing complexity, diversity and importance of drug/biologic/device combination products are driving regulators and industry to seek clearer, more risk-based and more harmonized regulatory processes and expectations. The first story focuses on the situation in Europe, and the second on the industry initiatives underway in the US, Europe and globally to help address the combination product regulatory challenges.

IPQ Monthly Update – October / November 2016 in Review

In October and November, IPQ was focused heavily on the experience and learnings FDA has gained in the first five years of its biosimilars review program and the improvements that the agency and industry want to see happen with user fee help in moving forward. Also in focus in the international section of the Update are: ● advancing and harmonizing other aspects of the biotech product CMC review process, including accelerated pathways, and ● the current pressure and incentives to apply QRM to excipients.
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