• Regulatory NewsRegulatory News

    ICH Updates on Guidelines, Future Topics

    The International Council for Harmonisation (ICH) on Friday said it has made “significant progress” on new and existing guidelines following a weeklong meeting in Charlotte, North Carolina earlier this month.   ICH also said it has finished implementing the reforms set out in 2015 to make the organization more global.   “Three years on from the reform of ICH, all organizational changes have been implemented,” ICH writes, noting that its membership has grown to incl...
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    FDA, EMA and PMDA Plot Harmonized Path for Antibiotics

    Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), met in Tokyo last month to plot out an approach that would allow drugmakers to conduct a single development plan for new antibiotics. The meeting, part of an ongoing effort by the three agencies to spur antibiotic development in light of growing concerns about antimicrobial resistance, was the third between the three ...
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    ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data

    The International Conference for Harmonization (ICH) on Wednesday released the concept paper and business plan for its upcoming guideline on targeted approaches to safety data collection. ICH says the goal of the guideline, referred to as ICH E19, will be to provide "harmonized guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemen...
  • Feature ArticlesFeature Articles

    Regulatory Harmonization Initiatives

    This article provides an overview of global regulatory harmonization initiatives and addresses how various regulatory and other organizations are working toward improving access to medicinal products, such as pharmaceuticals and medical devices, and increasing quality through internationally harmonized inspection standards. Introduction Government bodies, non-governmental associations and trade organizations all play a role in regulatory harmonization and convergence ...
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    EMA, Drugmakers Weigh FDA Draft Guidance on Physiologically Based PK Analyses

    With an eye toward more harmonization, the European Medicines Agency (EMA) earlier this month weighed in on the US Food and Drug Administration’s (FDA) draft guidance on physiologically based pharmacokinetic (PK) analyses, alongside pharmaceutical companies including Novartis, Merck and Bayer. EMA EMA’s Pharmacokinetic Working Party (PKWP) and the Modelling and Simulation Working Group (MSWG) are developing a “ Guideline on the Qualification and Reporting of Physiologi...
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    European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Maps International Regulatory Coordination Initiatives to Show Overlaps, Gaps The European Medicines Agency (EMA) has mapped cooperative regulatory initiatives to better understand how and where international peers are working together. EMA found there were a “myriad of initiatives but no strategic coordination,” prompting it to warn regulators are duplicating effo...
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    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...
  • 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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    Pharmaceutical Regulators Propose Principles for Indication Extrapolation for Biosimilars

    The International Pharmaceutical Regulators Forum’s (IPRF) Biosimilars Working Group (BWG) on Tuesday released a reflection paper outlining principles that regulators around the world can use for extrapolating indication(s) during the authorization process for new biosimilars. Background The IPRF was created as a safe harbor for discussion and promotion of harmonization among regulatory authorities and Regional Harmonization Initiatives (RHIs), including 11 regula...
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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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    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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    EU Proposes More Structured Convergence With FDA on Pharma Regulations

    The European Union has offered a new proposal that would further harmonize the pharmaceutical regulations between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), which could speed new drug approvals and manufacturing inspections in both regions. The seven-page proposal, released ahead of Transatlantic Trade and Investment Partnership (TTIP) negotiations between the EU and the US, would create a specific annex in those trade talks o...