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IPEC and IQ Consortium Team Up to Push for an Independent Pathway for New Excipient Review

A call to action is reverberating through the pharmaceutical community for the establishment of a viable regulatory pathway for new or modified excipients, which would empower industry to develop more quality-by-design-based formulations....

FDA and EMA Finalize Guidances to Help in Postapproval Change Management

FDA and EMA have issued final guidances intended to help industry better understand and manage the regulatory expectations for postapproval CMC changes....

Top Excipient DMF Problem Areas for FDA Include Authorization Letters, Paper Filings, and Annual Reports

FDA wants the excipient industry to better understand the challenges that the agency faces in reviewing drug master files (DMFs) and to improve their filings so that they do not impede the drug application process....

China’s FDA Voices Interest in Developing an Excipient DMF System at Meeting with IPEC China; India Among Countries Reviewing Excipient Regulatory Upgrades

China is among countries giving consideration to establishing a drug master file (DMF) system for excipients, as regulators world-wide seek to rationalize and improve their approaches to excipient oversight....

The Global Ingredient Archival System (GinAS) Progressing

A progress report on the “Global Ingredient Archival System” (GinAS) will be presented at the IPEC/ExcipientFest conference in late April. The system is being developed through cooperation between NIH, FDA, and industry with the intent to “provide a consistent definition of substances globally, and a common identifier for all the substances used in marketed medicinal products as well as active substances under clinical investigation.”

IPEC and IQ Explore Novel Excipient Pathways

IPEC-Americas is working with the IQ Consortium on how to foster a process that would promote quicker acceptance and approval of novel excipients. They are reaching out to member companies through a short survey for input on where and why novel excipients can improve drug delivery and who would be interested in participating on the […]

Interactions Between OGD’s Inactive Ingredients Database Working Group and IPEC on IID Content and Functionality Bearing Fruit

The cooperative effort between FDA’s Inactive Ingredients Database (IID) Working Group and the International Pharmaceutical Excipients Council (IPEC) to improve the IID’s content and functionality is beginning to bear fruit and will gain further momentum from the extra resources that will become available to the Office of Generic Drugs (OGD) to support projects that meet the Generic Drug User Fee Act (GDUFA) goals of creating a more efficient review process....

Vetting of ICH Q3D Pre-Step 2 Impacts Final Draft; LVP and E&L Issues Could Warrant Further Public Comment

Large volume parenterals (LVPs) and extractables and leachables (E&Ls) from container closure systems were two issues on which the ICH Q3D Expert Working Group (EWG) requested input from stakeholders during the Step 2 drafting process without getting much feedback, and may warrant attention during the draft’s public comment phase that runs through December, EWG members are advising....

IPEC and a Broader Coalition of Industry Associations Identify ICH Q3D Implementation Challenges and What is Needed to Meet Them

The International Pharmaceutical Excipients Council (IPEC) and the Coalition for Rational Implementation of the USP Elemental Impurities Requirements, of which IPEC is a member, have been taking a hard look at where the key challenges lie in implementing the elemental impurity standards in the new Step 2b draft of ICH Q3D and what tools they can provide to assist the pharmaceutical regulatory community in addressing them....

FDASIA Title VII Implementation Priorities and Action Plans Taking Shape

FDA has been sorting through the multi-faceted supply chain provisions of Title VII of the FDA Safety and Innovation Act (FDASIA) to identify which should be tackled first and to put action plans in place to implement them....
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