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The News in Depth

FDA Releases Guideline on Animal Drug Substance CMC Filings in CTD Format

FDA’s Center for Veterinary Medicine (CVM) has released a guideline on how to file drug substance CMC information for new and abbreviated new animal drug applications (NADAs/ANADAs) in the Common Technical Document (CTD) format. The CMC guideline was released as a final version rather than as a draft for comment....

EMA Issues Q&A on Supply Chain Traceability to Support Revised Medicinal Gas Annex

EMA recently issued a Q&A addressing supply chain traceability expectations for medicinal gases to support the revision to Annex 6 to the EU GMP Guide. The revised annex on “The Manufacture of Medicinal Gases” was adopted by the European Commission at the end of January and became effective at the beginning of August....

The August Issue of IPQ’s New “Monthly Update” Coming Soon

Don’t miss IPQ’s “Monthly Update – August 2010” due out later this week. IPQ’s new “Monthly Update” publication covers the key GMP and CMC developments in the US, Europe, and internationally....

India Strengthening its Central Regulatory Authority to Keep Pace with Industry Expansion

India is working to strengthen its central drug regulatory authority and related laws and regulations in response to its rapidly expanding domestic industry and the need for more interaction with foreign regulatory counterparts....

FDA/EMA Joint Inspection Program for Finished Products Seeking Applicants

The EMA is continuing to seek drug manufacturers willing to participate in its joint inspection program with FDA for finished products. In an August 11 announcement, EMA explained that companies that have submitted two equivalent applications for the same product to both EMA and FDA can request to participate in the pilot....

New Senate Bill Proposes Supply Chain Requirements for Drug Firms, Mandatory Recall Authority for FDA

A bill introduced in the Senate in early August would amend the Food, Drug and Cosmetic (FD&C) Act to provide FDA with new monetary penalty and recall tools and require drug firms to audit and document the steps in their product ingredient supply chains....

FDA Releases Q&A on Recalls, Holding and Distribution of Human Drugs

FDA provided on its website in early August a Q&A giving additional guidance on human drug recalls – their purpose, FDA’s authority to mandate them, over-the-counter (OTC) drug versus prescription drug recalls, and related investigations....

CDER Will Focus on Part 11 Compliance in Upcoming Inspections

FDA’s Center for Drug Evaluation and Research (CDER) will be conducting a series of inspections of drug manufacturers that will evaluate the industry’s understanding of and compliance with the Part 11 regulations. The inspection findings will be used to assess whether or not its related regulations and guidance need to be adjusted....

MHRA Pursuing New Monetary and Statutory Sanctions for Non-compliance

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is actively exploring the addition to its enforcement toolbox of a range of monetary and statutory sanctions for use against non-compliant drug manufacturers, similar to those available to FDA....

EU Restructuring PAT Team to Help Address Communication Challenges of the New Quality Paradigm

The EMA is restructuring its PAT Team to advance the team’s role in facilitating the communication within the agency and with industry needed to further the ICH Q8-10/QbD objectives....
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