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The News in Depth

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 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.

Combination Product Regulatory Improvements Remain High on Pharma’s 2017 Wish List

Clearer, more review/inspection coherent, more risk-based, and more harmonized regulatory expectations across the expanding universe of drug/device combination products will continue to be a high-priority focus for the pharmaceutical industry during 2017.

Focus Intensifying in Europe on Improving Drug/Device Combination Product Regulatory Communication

The challenges of the CMC regulatory process for drug/device combination products are getting increasing attention in Europe as industry and regulators join in the search for clearer and more efficient communication channels and regulatory procedures.

IPEC Leaders Tout Benefits of Documented Risk Assessments Called for in Recent Industry and Regulator Excipient GMP Standards

IPEC leaders are touting the multilayered benefits to excipient manufacturers and their pharma customers of establishing and documenting the more formal risk assessment processes called for in the recent industry and regulator excipient GMP standards.

CDER’s Office of Biotechnology Products Sheds Light on Biosimilar CMC Challenges and Solutions

While cautioning industry that developing a biosimilar remains a challenging marathon, FDA’s Office of Biotech Products (OBP) is now able to offer a lot more concrete advice on what it takes to cross the finish line.
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Front page Nov.Dec. 2015Click here for the November/December 2015 Monthly Update

 

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