The News in Depth
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 […]
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” 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.
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.
March 10, 2017 | Posted in The News in Depth
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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 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.
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.
January 26, 2017 | Posted in The News in Depth
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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.
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.
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.
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
- Documents and Archives — Live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library
Click here for the November/December 2015 Monthly Update
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.