• Regulatory NewsRegulatory News

    Transparency Push: EMA to Revise Policy on Document Access

    The European Medicines Agency (EMA) on Friday proposed a revision to its policy on accessing documents, extending the scope to include corporate documents, and increasing the publication of clinical data for pharmaceuticals. Since October 2016, EMA has published pharmaceutical trial data via its new website , including for: Mylan's aripiprazole, published most recently on 31 January 2017, Pfizer subsidiary Hospira's palonosetron, Praxbind  (idarucizumab), Tarcev...
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    CDRH Warns Three Foreign Medical Device Manufacturers

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China and South Korea. Among other violations, the warning letter for Taiwan-based HMD Biomedical, which manufactures GoodLife AC 300-305 Self-Monitoring Blood Glucose, says the company did not establish and maintain procedures for validating the device’s design, nor did it provide trainin...
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    FDA Warns One Japanese, One Chinese Drugmaker

    The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month. Sato Yakuhin Kogyo In its warning letter to Sato Yakuhin Kogyo, FDA cites the company for data integrity issues and failing to investigate out-of-specification test results uncovered over a five-day inspection of the company's Kashihara City, Japan facilit...
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    FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars

    Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar. The 18-page guidance is one in a series implementing the Biologics Price Competition and Innovation Act of 2009 (BPCIA) that established a pathway for the approval of such follow-on biologics. Four other final guidance documents and two o...
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    EMA to Launch Tailored Biosimilar Scientific Advice Pilot

    The European Medicines Agency (EMA) on Friday announced that it will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars. The tailored procedure will advise developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available (standard  scientific advice  does not include the assessment of existing data). EMA plans to run the pilot until ...
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    FDA to Publicly Disclose ‘Emerging Signals’ Info for Medical Devices

    The public will soon see more prompt notifications on medical device risks and potential risks thanks to guidance finalized Tuesday by the US Food and Drug Administration (FDA). Under the guidance, FDA will issue more prompt notifications to the public about medical device "emerging signals," including information that supports a new causal association or a new aspect of a known association between a device and an adverse event, or new information determined by FDA to h...
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    FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions’

    Fifteen top US Food and Drug Administration (FDA) officials published an article in the New England Journal of Medicine on Thursday calling into question some of the potential uses of real-world evidence (RWE) but also acknowledging that real world research and the concepts of a planned intervention and randomization “are entirely compatible." Defining RWE Rachel Sherman, deputy commissioner for medical products and tobacco in the Office of the Commissioner at FDA, wr...
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    FDA Warns Japanese API Maker Over Data Integrity Issues

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Japanese active pharmaceutical ingredient (API) maker Sekisui Medical Co., Ltd. for a series of data integrity issues at the company's Iwate, Japan site. Data Integrity Data integrity issues have been a growing concern for regulators in recent years. In 2016, both FDA and the European Medicines Agency (EMA) released new draft guidance for industry detailing their expectations for ...
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    FDA Offers Technical Rejection Criteria for Study Data

    For clinical and nonclinical studies starting after 17 December 2016, the US Food and Drug Administration (FDA) is requiring the use of data standards listed in the FDA Data Standards Catalog for all new drug applications (NDAs), biologic license applications (BLAs) and abbreviated new drug applications (ANDAs). Technical rejection criteria is being added to the existing electronic common technical document (eCTD) validation criteria to enforce the deadlines, FDA says. ...
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    European Regulatory Roundup: Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System (10 November 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System A senior politician overseeing the United Kingdom’s exit from the European Union has dismissed the need to retain certain aspects of the country’s current regulatory model post-Brexit. Asked in the House of Commons whether he agreed with industry leaders on the need for the UK to be part of a Europe-...
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    FDA Warns Chinese Drug Manufacturer for Limiting Inspection, Systemic Data Manipulation

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Beijing Taiyang Pharmaceutical Industry Co. on 19 October after the company limited FDA’s ability to conduct an inspection and manipulated manufacturing data. The warning letter follows FDA adding the company to two import alert lists in April, effectively halting its ability to ship products to the US. Barred Entry to Warehouse On 16 November 2015, FDA investigators observed throu...
  • Feature ArticlesFeature Articles

    Draft CFDA Guidance on Drug Data Management Practices

    The China Food and Drug Administration (CFDA) has recently issued a new draft guidance document on data integrity, covering the entire data lifecycle from R&D to commercial production and distribution. This article is a translation of the summary of the draft guidance. On 10 October 2016, CFDA issued draft guidance of drug data management practices for public comment. 1 Its purpose as detailed in Chapter I is the regulating the management of relevant data during th...