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    FDA Finalizes Guidance on Providing Postmarket Safety Reports in ICH Format

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance describing the conditions under which companies can use an alternative reporting format to satisfy postmarketing safety reporting requirements. The guidance explains the intricacies of how applicants can use an alternative reporting format, known as the International Council for Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), in place of the US periodic adverse drug expe...
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    FDA Begins Consultation on Update to ICH Pediatric Clinical Trials Guidance

    The US Food and Drug Administration (FDA) on Monday launched a three-month public consultation on an addendum to the International Council for Harmonisation's (ICH) guidance on pediatric clinical trials. The addendum, E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population , is intended to supplement ICH's E11 guidance by expanding  the discussion on issues related to pediatric clinical trials in light of scientific and regulatory ...
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    ICH Looks to Revamp GCP Guidelines, Adds New Members

    Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week. Following discussions, ICH said it plans to conduct a broad review of its guidelines related to GCP and clinical trial design, beginning with a reflection paper expected in early 2017. "This will include updating current guidance on interventional trials and expand on...
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    ICH Proposes Two New Guidelines

    The International Council for Harmonisation (ICH) has announced two new guidelines, with one (M9) providing recommendations to support the biopharmaceutics classification of medicinal products, while the other (M10) applies to the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies. Both of the new plans for the guidelines are part of efforts to harmonize regional differences in guidance documents and were finalized by ICH ...
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    WHO Seeks API Manufacturers for Prequalification Program

    The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and treatment of HIV/AIDS, hepatitis B and C, tuberculosis, malaria, neglected tropical diseases, influenza, diarrhea and support reproductive health. WHO invites manufacturers of selected APIs to submit Expressions of Interest (EOIs) for API evaluation and says the ultimate aim of...
  • ICH and Pharmaceutical Inspection Co-operation Scheme: No Expectations for China or India to Join

    While China and India continue to supply most of the world with pharmaceuticals (and continue to be plagued by quality and data integrity concerns), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Council on Harmonisation (ICH) – two of the largest international pharmaceutical regulatory schemes – say neither China nor India has any plans to join either group in the near future. Paul Hargreaves, chair of PIC/S, explained to attendees at the P...
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    FDA Begins Consultation on Two ICH Guidelines

    The US Food and Drug Administration (FDA) has issued two new International Council for Harmonisation (ICH) guidelines for public consultation: one on multi-regional clinical trials (MRCTs) and one on microsampling in study animals. Once ICH adopts a guideline, it then goes to ICH's five regulatory members in the US, EU, Canada, Japan and Switzerland for regional or national consultation before it can be implemented as an internationally harmonized document. Multi-Region...
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    ICH Adds 14 New Observers, Adopts New Guidelines at Lisbon Meeting

    The recently renamed International Council for Harmonisation (ICH) is adding new pharmaceutical and medical device regulators, industry groups and the US Pharmacopeia (USP) into its ranks as observers. The push to increase membership is part of the council’s global expansion . Announced at ICH’s June meeting in Lisbon, the new observers, who follow the addition of five regulatory authorities and regional health initiatives in December 2015, include: Association of...
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    FDA Issues New Draft Guidance on Elemental Impurities

    The US Food and Drug Administration (FDA) on Thursday issued new draft guidance on elemental impurities in drugs, with the goal of helping manufacturers comply with recent International Council for Harmonisation (ICH) and United States Pharmacopeial Convention (USP) standards. Specifically, the guidance is meant to help sponsors of new and generic drugs comply with standards established in USP General Chapters <232> Elemental Impurities – Limits and <233> Elemental...
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    FDA Offers Regional Specifications on Submission of ICSRs for Drugs and Biologics

    The US Food and Drug Administration (FDA) on Wednesday released the technical specifications to assist interested parties in electronically submitting individual case safety reports (ICSRs) and ICSR attachments to its Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The 19-page specifications document describes FDA’s technical approach for submitting ICSRs, for incorporating regional terminology, and for adding ...
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    ICH Genomic Sampling Guidance: FDA Begins Consultation

    The US Food and Drug Administration (FDA) on Thursday launched a two-month public consultation for input on a recently drafted International Conference for Harmonization (ICH) guideline on genomic sampling. Specifically, the guideline, E18 Genomic Sampling and Management of Genomic Data , seeks to create uniform standards for collecting, storing and handling genomic samples used in clinical trials. According to ICH, the guideline "will clarify points to consider ...
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    Seven Pharmaceutical Regulators and NIH Collaborate to Build Drug Ingredient Database

    Drug regulators from the US, Europe, Canada, France, Netherlands, Germany and Switzerland are attempting to build a database of substances used in medicinal products to ease the exchange of such information. The database, known as Global Ingredient Archival System (ginas), provides a common identifier for all APIs and provides a consistent definition of substances globally, consistent with the ISO 11238 standard . The effort, which its developers describe as similar ...