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IPQ Inside the global regulatory dialogue


Welcome to International Pharmaceutical Quality (IPQ)

 

INTERNATIONAL PHARMACEUTICAL QUALITY provides in-depth coverage of emerging drug, biologic and combination product CMC and GMP issues and developments, with a mission of helping advance and harmonize the quality regulatory process globally. Headquartered in Washington, IPQ is read by regulatory agencies and organizations, suppliers, consultants, law firms, and universities around the world.

IPQ tracks the industry/regulator dialogue at key international forums along with the developments, initiatives, regulations, guidances and standards in the quality regulatory arena to create a uniquely valuable resource for the intelligence gathering, knowledge management, and external communication needs of the pharmaceutical community.

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The News in Depth

KASA and PQ/CMC Initiatives Gain Momentum in FDA’s Effort to Strengthen Quality Review Process

The efforts of FDA’s Office of Pharmaceutical Quality (OPQ) to standardize and streamline the CMC information in applications and how it is reviewed – initially for abbreviated new drug applications (ANDAs), and eventually for NDAs, and even biological license applications (BLAs) – is beginning to take concrete form.

August 11 2019 / Read More

IPQ Monthly Update – June 2019 in Review

The first story in IPQ’s June issue provides an update on the effort going on in Europe to create a more transparent, effective, and uniform process for regulating the quality of drug-device combination (DDC) products and how a draft guideline issued in June is contributing to that effort. The second explores the regulatory developments in China, the implications for pharma and excipient suppliers producing products for a global market, and how IPEC is encouraging China to more closely align with international norms.

July 30 2019 / Read More

EMA’s Draft Guideline on Drug-Device Combinations Sheds Needed Light on Expectations for Device Assessment

EMA’s draft guideline on quality requirements for drug-device combination (DDC) products provides a template for the new concept of the notified body opinion (NBOp), intended to help ensure a consistent interpretation by individual assessors, notified bodies, and industry.

July 26 2019 / Read More
 

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● “In the News” — breaking stories on our website

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● “Monthly Updates” — 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

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CLICK HERE for the IPQ Monthly Update – June 2019 in Review


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

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Bill Paulson:
IPQ Editor-in-Chief

Paulson_picBefore launching IPQ in 2007, Bill served for over two decades as the primary author of “The Gold Sheet." During his career, Bill’s reporting and analysis has supported the global regulatory dialogue on advancing and harmonizing CMC and GMP processes for drugs and biologics to keep pace with the evolving technology.

 

Email: [email protected]

 

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