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  • Regulatory NewsRegulatory News

    ICH survey shows strong level of guideline implementation

    Most of the 55 guidelines from the International Council on Harmonisation that relate to quality, safety and efficacy, as well as multidisciplinary guidelines, have been adopted among its 10 non-founding members and observers and 30 pharmaceutical companies, according to the results of a new survey.   The survey was designed to monitor the adequacy and level of implementation to ICH guidelines by regulators and industry and complements one released in 2019 on the adopt...
  • Feature ArticlesFeature Articles

    January’s Regulatory Focus: The impact of disruption on the global regulatory community

    Feature articles during January focused the effects of disruption on global regulatory practice. In context of the COVID-19 pandemic, authors examined expedited approval pathways for test kits in southeast Asian countries; the role of digital promotional strategies in minimizing the impact of the pandemic on advertising, promotion, and labeling; and the importance of continuing soft-skills training during remote working. Under the broader framework of disruption, a group o...
  • Feature ArticlesFeature Articles

    New US dietary guidelines expand nutrient considerations for life stages

    The US Department of Agriculture and Department of Health and Human Services have jointly published the Dietary Guidelines for Americans every 5 years since 1980 to provide science-based dietary recommendations to promote health and prevent chronic disease. The guidelines inform federal food and nutrition policy programs as well as local, state, and national health promotion and disease prevention initiatives. In addition, professionals in public health, healthcare, educat...
  • Regulatory NewsRegulatory News

    EC Publishes New Guidelines on Good Clinical Practices for ATMPs

    Thanks to a 2007 regulation on advanced therapy medicinal products (ATMPs), the European Commission (EC) on Wednesday released new guidelines on the good clinical practice (GCP) requirements for these complex and innovative products that can include gene and cell therapies. The 15-page guidelines discuss clinical trial design, non-clinical studies, quality of the investigational ATMPs, the safe conduct of the clinical trial, upstream interventions on subjects and admini...
  • Regulatory NewsRegulatory News

    ICH Adds Four New Regulatory Observers

    Regulators from Argentina, Israel, Jordan and Saudi Arabia were recently approved by the International Council for Harmonisation (ICH) Assembly as Regulatory Observers. The approvals came at a meeting from 1-6 June in Amsterdam. ICH said the meeting was its largest biannual meeting ever and that progress was made on existing guidelines, training materials to support guideline implementation, the details of an ICH meeting in Silver Spring, MD, on 31 October on the revisi...
  • Regulatory NewsRegulatory News

    EMA Updates on 3Rs Guideline Review

    The European Medicines Agency (EMA) on Tuesday published a report on actions taken to update its guidelines following a review of 3Rs, or replacement, reduction and refinement, principles to reduce the need for animal testing of medicinal products.   In 2014, EMA’s Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP) launched a review to update their guidelines to ensure they align with 3Rs best practices....
  • Regulatory NewsRegulatory News

    FDA Opens for Comment Revised ICH Guideline on Statistical Principles for Clinical Trials

    The US Food and Drug Administration (FDA) on Monday opened for comment a newly revised International Council for Harmonisation (ICH) guideline intended to better align the choice of statistical methods with questions of regulatory importance, and to improve the reliability of decisions about and representations of the effects of medical products. The 31-page draft guidance, according to FDA, clarifies, updates and extends the earlier ICH guidance, entitled "E9 Stati...
  • Regulatory NewsRegulatory News

    Pharmaceutical Inspection Co-operation Scheme Offers New Strategic Plan Through 2019

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week unveiled a new road map for the next two years during its February meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities. Training was cited as PIC/S’ “most important field of activity,” and following the July 2016 launch of the PIC/S Inspectorates’ Academy (PIA), the group says considerations will be made on training inspectors on the revised Annex 1 on steril...
  • 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

    ICH Advances Three Guidance Documents

    The International Council for Harmonisation (ICH) earlier this week announced the advancement of two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase. On the Step 4 front, the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (GCP) advanced. “The current amendment (ICH E6(R...
  • Regulatory NewsRegulatory News

    Amended ICH GCP Guideline Addresses Evolution of Trials Landscape

    The International Conference on Harmonization (ICH) has amended its good clinical practice (GCP) guideline with the aim of helping industry address the increasing scale, complexity and cost of clinical trials. The evolving use of technology and new risk management processes offer opportunities to increase efficiency, ICH says. The updated guideline is intended to provide a unified standard for the regulatory authorities in the EU, Japan, US, Canada and Switzerland to fa...
  • US Throws Out 1995 Standard for Generics Stability Testing, Adopts ICH Standards for NDAs Instead

    The US Food and Drug Administration (FDA) has released a new guidance for industry that pertains to stability testing recommendations for generic drug products submitted under 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) as an abbreviated new drug application (ANDA) or a drug master file (DMF). The June 2013 guidance document, ANDAs: Stability Testing of Drug Substances and Products , explains that, "Over the past few years, the Office of Gener...