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  • Regulatory NewsRegulatory News

    FDA Announces Major Agency Reorganization, With Focus on Drug Quality

    The US Food and Drug Administration (FDA) is finally preparing to launch the Office of Pharmaceutical Quality (OPQ), a new effort to focus on the quality of drug products. Background The creation of OPQ was proposed in September 2012 by Janet Woodcock, the director of the Center for Drug Evaluation and Research (CDRH). "Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently ha...
  • Regulatory NewsRegulatory News

    Australian Regulator TGA Undergoing Reorganization

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) has announced (11 September) an internal reorganization as part of broader structural changes within the Department of Health following the Finance Ministry’s call for a " smaller and more rational " government. The D...
  • Goodbye, KFDA: Korean Regulator Gets New Name, Decentralized Authority After Reorganization

    The Korean Food and Drug Administration (KFDA) is no more, the agency said in an announcement on 28 March 2013. Instead, it-like its Chinese counterpart, the China Food and Drug Administration (CFDA), formerly the State Food and Drug Administration-will soon change its name after being reorganized and upgraded in statutory authority. KFDA will now be called the Ministry of Food and Drug Safety (MFDS), it said. The name change closely follows CFDA's, which unceremoniously...
  • 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...
  • EMA Announces Huge Overhaul of Operations, Processes

    The European Medicines Agency (EMA) is preparing to reorganize its operations, processes and offices in 2013, it has announced. In a statement released on its website on 19 December 2012, the agency said the overhaul will be "focused on increasing the efficiency of its scientific activities and information- and communication-technology operations." A particular focus will be placed on how it supports the mission of its scientific committees-the Committee for Medicinal P...
  • Japan's PMDA Reorganizes Biologics Offices

    Japan's Pharmaceutical and Medical Device Agency (PMDA) has reorganized its Offices of Biologics I and Biologics II, respectively, into new entities known as the Office of Cellular and Tissue-based Products and the Office of Vaccines and Blood Products. As of 1 October 2012, the Office of Cellular and Tissue-based Products will be responsible for cellular and tissue-based products, CMC of gene therapy products, CMC/quality of biologics, biosimilars, and Cartagena Act ...
  • Obama to Call for Reorganization, Merger of 6 Federal Agencies

    • 13 January 2012
    • By
    US President Barack Obama plans to issue a statement this morning calling for the reorganization of six federal agencies dealing with trade and commerce, reports The Associated Press. The report quotes an unnamed senior administration official who says that the President will call for the Commerce Department, Small Business Administration, Office of the US Trade Representative, the Export-Import Bank, the Overseas Private Investment Corporation and the Trade and Deve...