• Regulatory NewsRegulatory News

    ICH shares "work-in-progress" update to GCP guidance

    The International Conference on Harmonization (ICH) has made available a draft version of its updated principles for good clinical practice. The principles are to be considered a “work-in-progress,” wrote ICH in announcing the availability of the updates, which are still in development by the ICH’s E6(R3) expert working group.   “The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliabl...
  • RF Quarterly

    RF Quarterly, March 2021: Global clinical trials

    Welcome to the inaugural issue of RF Quarterly featuring original, thematically developed content by regulatory experts addressing key areas and emerging issues in the global regulatory landscape. RF Quarterly is a member-exclusive addition to the regular monthly  Regulatory Focus  feature articles and replaces the former quarterly article series. The theme for this issue is Global Clinical Trials.   Clinical trials are an essential component of pharmaceutical re...
  • RF Quarterly

    Clinical trials, good clinical practice, regulations, and compliance

    This article provides an overview of the international and national guidelines associated with clinical trials. The authors highlight the importance of multiregional clinical trials and outline the principles of good clinical practice (GCP) and regulatory compliance.   Introduction Clinical trials are essential components of pharmaceutical research and development. A clinical development program’s broad aim is to treat a specific indication in a certain population to...
  • 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

    EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials

    The European Medicines Agency (EMA) on Thursday opened for consultation a new guideline on the structure and data requirements for a clinical trial application for exploratory and confirmatory trials with advanced therapy investigational medicinal products (ATIMPs). The 53-page guideline addresses development, manufacturing and quality control, featuring sections on quality documentation (including parts on the active substance and the investigational medicinal product)...
  • Regulatory NewsRegulatory News

    European Commission Consults on Orphan Drug Applications

    The European Commission on Tuesday launched a targeted consultation to provide input on a revision of its guideline on the content and format of applications for orphan drug designation, as well as the transfer of designations between sponsors.   "The comments received will be taken into account by the European Commission in the finalization of the guideline on the format and content of application for designation as orphan medicinal products and on the transfer of des...
  • Regulatory NewsRegulatory News

    EMA Consults on Harmonized Antibacterial Drug Development Guideline

    The European Medicines Agency (EMA) on Monday released a draft version of its guideline on developing antibacterial medicines for consultation.   The 30-page guideline, which is now on its third revision, has been updated to reflect a harmonized approach to antibacterial drug development based on the tripartite discussions between EMA, the US Food and Drug Administration and Japan's Pharmaceuticals and Medical Devices Agency.   "Antimicrobial resistance is a glob...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CDSCO Seeks Feedback on Planned Risk-Based Pharmacovigilance Inspection Program

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   CDSCO Seeks Feedback on Planned Risk-Based Pharmacovigilance Inspection Program   The Central Drugs Standard Control Organization (CDSCO) is seeking feedback a proposed risk-based pharmacovigilance inspection model. CDSCO plans to adopt a four-year cycle for pharmacovigilance inspections and prioritize the assessment of companies that introduce new drugs to the marke...
  • Regulatory NewsRegulatory News

    EMA Adopts Guideline on Clinical Trials for Rheumatoid Arthritis Treatments

    The European Medicines Agency (EMA) on Wednesday announced the adoption of a guideline, first drafted in 2011, on the clinical evaluation of medicinal products in the treatment of the autoimmune disease rheumatoid arthritis (RA). "Currently, several biomarkers which may predict disease progression and response are under development. In the future, this may lead to a more individually targeted treatment approach," the guideline said. "Despite significant advances in...
  • Regulatory NewsRegulatory News

    Reproductive Toxicity: FDA Consults on Revised ICH Guideline

    The US Food and Drug Administration (FDA) on Thursday released a draft guidance for consultation on a revision to the International Council for Harmonization (ICH) guideline on reproductive toxicity testing. The draft ICH guideline, S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals , was endorsed by the ICH Assembly in August and is currently in Step 3 of the formal ICH procedure as participating regulators hold public consultations on the guideline...
  • Regulatory NewsRegulatory News

    EMA Drafts Guideline on RSV Treatments and Vaccines

    The European Medicines Agency (EMA) on Tuesday released for consultation a new guideline to help companies develop new medicines, direct-acting antiviral agents, monoclonal antibodies and vaccines to treat and prevent infections caused by the respiratory syncytial virus (RSV). According to EMA, RSV is a common respiratory virus that usually causes mild, cold-like symptoms that most recover from, though RSV can be serious, especially in infants and older adults. Curr...
  • Regulatory NewsRegulatory News

    EMA Consults on Revised Factor VIII Product Guidelines

    The European Medicines Agency (EMA) on Monday issued two draft revised guidelines on plasma-derived and recombinant coagulation factor VIII products that remove requirements for conducting clinical studies in previously untreated patients (PUPs). Background Factor VIII products are used to treat or prevent bleeding in patients with hemophilia A (congenital factor VIII deficiency). The development of inhibitor antibodies is one of the greatest potential complications inv...