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  • Regulatory NewsRegulatory News

    EMA and FDA to Begin Sharing Commercially Confidential Information

    Editor's note: this article has been updated with a statement from FDA clarifying that the agency must sign a confidentiality agreement with each EU country before unredacted inspection reports may be shared. As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will soon share non-public and commercially confidential information, including trade secret information. The a...
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    FDA Warns Chinese API Maker for Data Integrity Issues

    The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year. Background In March, FDA placed Qinhuangdao on import alert as a result of the inspection findings, an action that raised alarms at the World Health Organization (WHO), as the company is the only prequa...
  • 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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    FDA Warns Two Drugmakers in China and India for Data Integrity Violations

    The US Food and Drug Administration (FDA) has warned two drugmakers, USV Private Limited in Daman, India and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. in Zhangqiu City, China, over data integrity and manufacturing issues uncovered during inspections last year. Data integrity has been a growing area of focus for FDA, with an increasing number of warning letters and Form 483s citing data integrity violations, many for manufacturers in China and India. USV Warning Let...
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    FDA Warns Wockhardt Subsidiary, Says Seven of Company's Facilities Out of Compliance

    The US Food and Drug Administration (FDA) has warned Wockhardt subsidiary Morton Grove Pharmaceuticals over quality control and data integrity issues. In a warning letter dated 17 February, FDA details six violations uncovered during a month-long inspection of the Morton Grove, Illinois facility in January and February 2016. In 2014, FDA issued the site a Form 483 detailing 12 observations covering product testing, recordkeeping and data integrity issues. In a filing ...
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    FDA Warns Megafine Over Data Integrity Violations at Second Facility

    The US Food and Drug Administration (FDA) last month warned Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma Ltd. over data integrity and manufacturing violations at its Gujarat, India facility. The warning letter comes after FDA inspected the Gujarat facility over the course of five days last September, and less than a year after the agency warned Megafine for a host of data integrity violations at its other facility in Maharashtra, India tha...
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    US and EU Forge Landmark Agreement to Mutually Recognize Drug Manufacturing Inspections

    After wrangling over the details of trade secrets and inspection differences, the US and EU on Thursday finally announced they have agreed to mutually recognize one another’s pharmaceutical manufacturing inspections – a deal likely to lead to less duplicative inspections and lower costs on both sides of the Atlantic. Originally part of the Transatlantic Trade and Investment Partnership discussions under President Barack Obama , the agreement will allow US and EU regulat...
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    FDA Warns China API Manufacturer for Data Integrity Violations

    The US Food and Drug Administration (FDA) in late February warned Fosun Pharmaceutical subsidiary, the formerly Chinese state-owned Chongqing Pharmaceutical Research Institute (CPRI), over data integrity issues. The warning letter comes after a four-day inspection of CPRI's active pharmaceutical ingredient (API) and contract research and manufacturing facility in Chongqing, China last May. During the inspection, FDA says it found evidence the company was habitually del...
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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 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 Warns Teva’s Banned Hungary Manufacturing Facility

    The US Food and Drug Administration (FDA) has warned Teva’s Gödöllő, Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as well as the company’s data integrity program. The warning letter, sent on 14 October, followed FDA’s eight-day current Good Manufacturing Practices (cGMP) inspection of the facility, in January 2016. Teva said in an SEC filing that it “has undertaken corrective actions to address both the ...
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    'The Rooms Had Never Been Cleaned': Two New FDA Warning Letters for Chinese Manufacturers

    The US Food and Drug Administration (FDA) has sent warning letters to two Chinese active pharmaceutical ingredient (API) makers over data integrity and good manufacturing practice (GMP) violations. In recent years, FDA has increased its level of oversight of overseas manufacturers, which has led to a greater number of warning letters being issued to such companies. So far in 2016, FDA's Office of Manufacturing Quality has issued 25 warning letters, 11 of which were...