RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    FDA Warns Teva API Plant in China

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 10 April to Teva for deficiencies related to an active pharmaceutical ingredient (API) manufacturing site in Hangzhou, China. The letter, first disclosed in an SEC filing in which the company said it would respond by 1 May, includes two observations for failing to establish written procedures to monitor the progress and control the performance of processing steps that may cause v...
  • Regulatory NewsRegulatory News

    MHRA Investigates GMP Deficiency Trends From 2016

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Tuesday released a new report on the trends seen from inspecting pharmaceutical manufacturing plants and evaluating their good manufacturing practices (GMPs) in 2016. Compared to 2015, MHRA conducted 21 more total GMP inspections in 2016, and three more foreign inspections. But like in 2015, the most cited deficiency for 2016 was related to companies’ quality systems. Sterility assurance, producti...
  • Regulatory NewsRegulatory News

    AdvaMed CEO Confident of Device Tax Repeal This Year

    The Advanced Medical Technology Association's (AdvaMed) President and CEO Scott Whitaker said Tuesday he's confident that the medical device tax introduced under the Affordable Care Act will be repealed this year. Whitaker made the remarks during a call with reporters on Tuesday, where he also discussed potential changes to the US Food and Drug Administration's (FDA) inspection program for devices. Device Tax Repeal Despite the stalling of the Obamacare replacement b...
  • Regulatory NewsRegulatory News

    FDA Office of Regulatory Affairs Realignment to Begin in May

    The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren. Shuren made the announcement to members of the House Energy & Commerce Committee on Tuesday at a hearing on the Medical Device User Fee Amendments , which must be reauthorized by 30 Septemb...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Increases Inspections Following Adoption of Risk-Based Approach (7 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Steps up Initial GMP Inspections After Adopting Risk-Based Approach The Therapeutic Goods Administration (TGA) of Australia has increased initial inspections of drug manufacturing plants at home and overseas. TGA reported double-digit increases in the number of initial inspections of local and foreign firms in the back half of last year following the introduction ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Senators Look to Overhaul Medical Device Inspections

    Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks dramatically alter the US Food and Drug Administration's (FDA) process for inspecting device manufacturers. Specifically, the bill calls for FDA to implement a more consistent, risk-based inspection process, as well as to improve communications with device makers regarding inspections and findings. "The current device facility inspection process lacks transparency, predictability an...
  • Regulatory NewsRegulatory News

    EMA Outlines GCP Inspection Plan for 2017

    The European Medicines Agency (EMA) on Tuesday released its 2017 work plan for good clinical practice (GCP) inspections, which involves collaborating with the US Food and Drug Administration (FDA) to limit duplicative inspections. Among other expectations for the coming year, the EMA’s GCP Inspectors Working Group will develop new and revised guidelines on the redaction of inspection reports to protect personal data and commercially confidential information, as well as ...
  • Regulatory NewsRegulatory News

    Do FDA’s Foreign Offices Help Keep US Drugs Safe? GAO Says Answer is Unknown

    A new Government Accountability Office (GAO) report offers some good news and some bad news for the US Food and Drug Administration’s (FDA) foreign offices: The good news is that foreign inspections of drug, medical device and food manufacturing sites are increasing year over year, but the bad news is that FDA has yet to determine whether these foreign offices meaningfully contribute to US drug safety. Back in 2008, FDA opened its first foreign offices as part of its res...
  • Regulatory NewsRegulatory News

    FDA and MHRA Break Down Foreign Inspection Data

    Both the US Food and Drug Administration (FDA) and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) are slowly ramping up their inspections of foreign manufacturers, according to the latest statistics. On FDA’s side, investigators conduct on-site inspections of regulated foreign establishments to proactively ensure the safety and efficacy of products manufactured abroad and sold in the US. In FY 2016 , FDA conducted 78 foreign inspections of human dru...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Offers Draft Guidance on Generic Drug Manufacturing Inspections (3 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Ends OTC Status of Codeine Drugs Following Review The Therapeutic Goods Administration (TGA) of Australia has reclassified codeine-containing drugs as prescription-only medicines. TGA decided to prohibit over-the-counter (OTC) sales of products containing codeine after reviewing the safety and efficacy of the painkiller and assessing how it is handled by foreign r...
  • Regulatory NewsRegulatory News

    Japan Joins International API Manufacturing Inspection Program

    Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced Thursday that it will join with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators to improve the efficiency and effectiveness of good manufacturing practice (GMP) inspections for sites producing active pharmaceutical ingredients (APIs). “PMDA has decided to join this program from 24 November 2016,” the agency said in an announcement. “The participation in...