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  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Shifts to Random Inspections (6 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DTAB Proposes Stipulations to Indian Plan for Permanent Licenses The Indian Drugs Technical Advisory Board (DTAB) has given its conditional support to end the need to renew licenses to make, sell and test drugs. DTAB is broadly in favor of the idea, but has suggested stipulations that are more burdensome than those proposed by the Drug Controller General of India (DCG...
  • Regulatory NewsRegulatory News

    FDA Calls on Pharma Companies to Join Manufacturing Inspection Program

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday announced the launch of the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program, which is meant to help OPQ staff learn more about industry’s drug development and manufacturing processes. The program, which aims to bring groups of OPQ staff to observe operations of commercial manufacturing, pilot plants and pharmaceutical test...
  • Regulatory NewsRegulatory News

    US, EU Look to Mutually Recognize GMP Inspections by January 2017

    The US and EU say they have made more progress on harmonizing good manufacturing practice (GMP) inspections and could reach a deal by January 2017, according to a report on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP). Progress on mutually recognizing GMP inspection has been ongoing since June , particularly as the US Food and Drug Administration (FDA) has observed at least eight audits since 2014 and as six additional aud...
  • Regulatory NewsRegulatory News

    FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation

    The US Food and Drug Administration (FDA) on Monday released a summary of hospital inspection findings, as well as Form 483s for 15 hospitals, detailing failures of the hospitals to report medical device-related adverse events. Several high-profile hospitals were included in the list, including Los Angeles-based Cedars-Sinai Medical Center and Boston-based Brigham and Women’s Hospital , for their failure to keep written medical device reporting procedures and to repo...
  • Regulatory NewsRegulatory News

    FDA Warns Japanese Company for Impeding Inspection

    The US Food and Drug Administration (FDA) has warned Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA investigator from conducting an inspection of the company's facility in Takasago City, Japan, last December. According to FDA, Nippon Fine Chemical employees physically blocked an FDA investigator from conducting portions of the inspection, refused to hand over records and prevented FDA from taking photographs of eq...
  • Regulatory NewsRegulatory News

    EU, Japan to Share More Information on GMP Inspections

    The European Directorate for the Quality of Medicines and Healthcare (EDQM) this week announced a new agreement with Japanese authorities to share more information on the outcome of good manufacturing practice (GMP) inspections of manufacturing sites of active pharmaceutical ingredients (APIs) of interest to both Europe and Japan. The agreement follows the exchange of letters on 13 September 2016 in which Japan’s Pharmaceutical Safety and Environmental Health Bureau of ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Australia to Adopt 10 EMA Guidelines (4 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia Starts Consultation on Planned Adoption of 10 EMA Guidelines The Therapeutic Goods Administration (TGA) of Australia is seeking feedback on its plan to adopt 10 European Medicines Agency (EMA) guidelines. Most of the documents are replacements for existing EMA texts previously adopted by TGA, but some, such as guidelines on clinical development of drugs agai...
  • Feature ArticlesFeature Articles

    Surviving Your First FSMA Inspection

    This article provides an overview of the new FSMA regulations and suggests some recommended steps to prepare for inspections, including preventive controls, supply chain management and good record keeping practices. Introduction Without question, the US Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) is the most significant food safety law of our generation. The original Federal Food, Drug, and Cosmetic Act of 1938, included a single sentence ...
  • Regulatory NewsRegulatory News

    FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies

    The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies. The 142-page proposed rule outlines what’s referred to as a “GLP Quality System,” which will involve additional management responsibilities and standard operating procedures (SOPs), as well as a more nuanced approach for multi-site ...
  • Regulatory NewsRegulatory News

    Indian Sites From Pfizer, Wockhardt Face Complications After GMP Inspections

    • 08 August 2016
    Pfizer and Wockhardt are struggling to keep pace with pharmaceutical good manufacturing practice (GMP) regulations as two recent inspections of their manufacturing sites in India resulted in a US ban for Wockhardt and a temporary suspension of the Pfizer site. For Pfizer, the inspection of its Chennai-based site, acquired as part of its $16 billion purchase of Hospira, was a joint effort for officials from four regulators: the US Food and Drug Administration (FDA), UK’s...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Quality Issues Push TGA to Seek New Source for Angina Drugs (2 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Looks for new Sources of Angina Drug After Quality Issue Threatens Supply The Therapeutic Goods Administration (TGA) of Australia has started talking to manufacturers about establishing an alternative source of glyceryl trinitrate (GTN) tablets. Officials initiated the search to minimize the impact of quality problems at Arrow Pharmaceuticals, the sole supplier o...
  • Regulatory NewsRegulatory News

    GAO on Drug Shortages: FDA’s Prioritization of Generic Injectable ANDAs is Helping

    As the number of new drug shortages has generally decreased since 2011, the US Government Accountability Office (GAO) said that although it cannot establish a causal link, the US Food and Drug Administration’s (FDA) prioritization of reviewing hundreds of applications and supplements during the time period GAO examined helped address some of those shortages. New drug shortages peaked in 2011, with 257 reported, GAO says in a recently released report, though that number ...