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    FDA Finalizes Guidance on Emerging Manufacturing Tech Program

    The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing how drugmakers can participate in the agency's program to advance the use of emerging manufacturing technologies, such as continuous manufacturing or 3D printing. "In recent years, we've seen significant advances in the modernization of drug manufacturing, including shifts to continuous manufacturing and the first 3D printed drug. These advancements have led to improved products for pa...
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    FDA Warns Chinese Drugmaker Over Fake Test Results, Blocking Access to Inspectors

    The US Food and Drug Administration (FDA) has warned Chinese drugmaker Shandong Vianor Biotech for violating good manufacturing practice (GMP) requirements following an inspection of the firm's Linyi, Shandong facility last May. According to FDA, the firm's management admitted to falsifying analytical test results used to release a lot of its products to the US. In another instance, FDA says the firm reported that a batch of one of its products was within specification ...
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    EMA’s CHMP Adopts Updated Guideline on Manufacture of Finished Dosage Form

    The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) on Monday adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA). The update, drafted in July 2015 , comes as there has been an increasing trend toward the outsourcing of manufacturing and more complex supply chains. The guideline "does not introduce new requirements" on authorized drugs, though t...
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    Proposed and Final FDA Rules: What’s Left in 2017

    The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings. Proposed Rulemakings Among the proposals coming are rulemakings dedicated to pediatric study plan requirements , internal decision making and supervisory review at FDA’s Center for Devices and Radiological Health, the withdrawal of a regulation that a...
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    FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics

    As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report. "Under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities, o...
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    FDA Warns Lonza’s Class II Device Manufacturing Site

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 21 April to Lonza’s contract manufacturing site for Class II devices in Walkersville, MD. The four observations from the inspection conducted from 18 January 2017 through 6 February 2017 deal with validation failures, the site’s failure to develop, conduct, control and monitor production processes, corrective and preventive action (CAPA) failures and a failure to adequately establis...
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    FDA Official Highlights Foreign Supply Chain Challenges

    Drugmakers should be mindful of the risks involved with relying on foreign manufacturers as part of their supply chain, said Thomas Cosgrove, director of the US Food and Drug Administration's (FDA) Office of Manufacturing Quality within the Center for Drug Evaluation and Research. Speaking at the Food and Drug Law Institute's annual conference on Friday, Cosgrove detailed some of the biggest challenges drugmakers face when contracting with foreign manufacturers, which fi...
  • Asia Regulatory Roundup: CFDA Increases Drug Regulation Budget by 31% (11 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Tells Manufacturers to Review Quality Systems to Ensure Data Integrity The Therapeutic Goods Administration (TGA) of Australia has told manufacturers to review their quality systems and the effectiveness of their data management and integrity controls. TGA made the request in a post detailing its intent to step up its focus on data management and integrity. Offici...
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    A Peek Behind the Curtain: 706 FDA Form 483 Requests in 2016 for Indian and Chinese Manufacturers

    As China and India continue to manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) is tasked with regulating these manufacturing sites and in 2016 that involved issuing hundreds of Form 483s and responding to more than 700 requests for the inspection reports. Thanks to the Freedom of Information Act, Focus obtained from FDA two lists detailing not only the 86 requests for the Form 483s issue...
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    FDA Unveils Regulatory Science Progress Report

    The report, covering fiscal years 2015 and 2016, notes significant US Food and Drug Administration (FDA) progress in refining non-clinical and clinical tools to better evaluate medical products, advancing manufacturing and quality, and enhancing internal IT tools to support the scientific review of regulatory applications. Non-Clinical In terms of the non-clinical predictive models, the report notes that FDA researchers developed a wide variety of computational tools th...
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    Drug Supply Chain Security: New APEC Toolkit to Aid Collaboration

    With the pharmaceutical supply chain becoming more global and complex, regulators, industry groups and academics from around the world have developed a new toolkit of resources to increase harmonization across borders to ensure the quality of drugs from manufacture through ingestion. The new toolkit, born out of a five-year collaborative project that actually took four years to complete, brings expertise from the US Pharmacopeial Convention (USP), US Food and Drug Admin...
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    Pharma Inspection Co-operation Scheme Criticizes Plan to Lower GMP Requirements for ATMPs

    The regulatory group known as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) said in a letter released this week that it is “unanimously concerned” about the public health and safety impact of a new European Commission guideline that would lower good manufacturing practice (GMP) requirements for advanced therapy medicinal products (ATMPs). "By lowering the GMP requirements for ATMPs, the European Commission is not only exposing patients to an increased risk t...