The US Food and Drug Administration (FDA) on Monday said it is drafting and seeking comment on the use of standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements for electronic submission. FDA, which is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document, said the move to standardize PQ/CMC data elements and terminologies will improve the efficiency and quality of th...

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...

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...

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...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Asks to Suspend Authorizations of Four Imaging Agents After Reviewing Safety The Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorizations for four linear gadolinium contrast agents. PRAC put forward the proposal after finding “convincing evidence” accumulations of gadolinium are present in the brain many month...

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 ...

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...

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...

Top officials at the US Food and Drug Administration (FDA) are defending the agency's flexibility to accelerate the availability of products by considering diverse data sources in product submissions. In an article in Nature Reviews Drug Discovery on Friday, Rachel Sherman, deputy commissioner for medical products and tobacco in the Office of the Commissioner at FDA, writing alongside former FDA Commissioner Robert Califf and other high-ranking agency officials, argue ...

The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March. Among those provisions of the law that must be acted upon within 90 days of the law’s enactment (or by 13 March) inc...

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...

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...