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  • Regulatory NewsRegulatory News

    New Guidance Clarifies Saudi Labeling Requirements for Medical Devices

    Content provided by  Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA). The guidance  clarifies labeling rules previously included in the Saudi Medical Devices Interim Regulation more so than adds any new or altered requirements. Among the key clarifi...
  • As China's FDA Undergoes Regulatory Consolidation, Its Chief Promoter Gets a Name Change

    For years, the China Center for Pharmaceutical International Exchange (CCPIE) has been a semi-public institution aimed at helping the China Food and Drug Administration (CFDA) establish cooperative agreements and relationships with outside entities, particularly outside China. Going forward, it will continue to do and be just that, only under a different name. According to the agency's website, CCPIE is now the China Center for Food and Drug International Exchange (CCFD...
  • Changes to Medical Device Law Clear China’s State Council

    China's State Council Executive Committee cleared a Revised Medical Devices Bill on 12 February 2014 that modernizes China's current device law, which was first implemented more than a decade ago. The changes include adjustments to the definition of medical devices and device classification rules; additional measures for monitoring the quality of medical device production and risk monitoring; new medical device adverse event monitoring, including traceability and reca...
  • China in High Risk Regulatory Phase, According to CFDA Commissioner

    In a recent interview with the press, China Food and Drug Administration (CFDA) Commissioner Zhang Yong noted that the country has entered a development phase for regulated industry that is marked by a high incidence of safety risks.  He attributes this current phase to the country's rapid economic development, which has also led to the rapid growth of local regulated industry.  Based on international experience as a reference point, China's regulated indust...
  • China's SFDA Becomes CFDA amidst Consolidation of Power and New Leadership

    Say goodbye to China's State Food and Drug Administration (SFDA); instead, say hello to its new name, the China Food and Drug Administration (CFDA). The agency recently underwent a reorganization that saw much of China's food and drug regulatory powers consolidated into the agency, elevating it back to a ministerial-level agency directly under the State Council. Since 2008, the agency had been downgraded to a position of lesser importance after a series of corruption s...
  • China Recognizes Device Electromagnetic Testing Centers

    In December 2012, China's State Food and Drug Administration's (SFDA) National Medical Standardization Technical Committee issued a standard (YY 0505-2012) that is equivalent to the international electromagnetic compatibility testing standard (IEC 60601-1-2), with an effective date of 1 January 2014. To date, the SFDA says it has recognized a number of medical device testing institutions that are qualified to carry out the detection of electromagnetic compatibility of...
  • Consolidation of China's SFDA Grants Agency More Prestige, Power

    China's State Food and Drug Administration (SFDA) will soon be revamped and given additional authority under a planned governmental reorganization that will see various regulatory oversight agencies consolidated under its authority, reports various news outlets. Need for Change: A Crisis of Confidence News of the reorganization broke last week in a report by the South China Morning Post , which wrote that the National People's Congress (NPC)-the last under outgoing Pr...
  • China FDA Report Claims Reduced Drug Lag

    A new report released by China's State Food and Drug Administration's (FDA) Center for Drug Evaluation shows that review and approval times for clinical trial applications for most drugs averages about 8 months per products, while oncology products fare the best at five months. The report , released 28 February 2013, also noted that "the gap between the time-to-market of imported drugs at home and abroad also significantly shortened" relative to years prior. The SFDA e...
  • China's SFDA Announces Major Reforms to Drug Regulatory Process

    China's State Food and Drug Administration (SFDA) has announced that it is implementing a series of reforms designed to improve the drug review and approval process, "and to promote the healthy development of China's pharmaceutical industry."  Wang Lifeng, director of the SFDA's drug registration department, said the plan provides incentives for the research and development of innovative clinical drugs, adding that the approval process will be shortened for these...
  • China Finalizes Revised Drug Distribution Rules

    China's State Food and Drug Administration (SFDA) has announced the release of the revised pharmaceutical Good Supply (Distribution) Practices (GSP) slated to take effect on 1 June 1 2013, with a three-year transition period for the implementation by companies of the mandated quality control system. Drug makers who fail to meet the amended GSP standards by 2016 will not be allowed to continue operations, regulators said. This is the first major revision of the GSPs i...
  • China Orders Foreign Drug Companies to Designate Local Agents

    China's State Food and Drug Administration (SFDA) issued a Notice on 29 January 2013 to provinces, municipalities and ports concerning the implementation of the national electronic monitoring system for imported pharmaceuticals, which will require foreign-based companies to have a local designate. Foreign companies must designate a local Chinese pharmaceutical company, pharmaceutical wholesaler, subsidiaries or offices as their electronic monitoring agent in China.&nbs...
  • China Sets Deadlines for Drug GMP Implementation

    China's State Food and Drug Administration (SFDA), the National Development and Reform Commission, the Ministry of Industry and Information Technology, and the Ministry of Health issued on 21 December 2012, a joint notice to the provinces and municipalities setting forth deadlines for implementation of the revised good manufacturing practices (GMPs) by the pharmaceutical industry.  Injectable drug manufacturers must implement the revised GMPs by 1 January 2014, a...