• ICH Looks to Increase Transparency of its Activities, Processes with New Procedures Manual

    Within regulatory circles, one might argue the biggest trend in recent decades has been the shift toward global harmonization, with a large number of groups launching to help bring about a convergence of good regulatory practices resulting in benefits for both regulators and industry alike. But if a critique is present, it is that the processes by which this harmonization occurs can often be unnecessarily opaque, limiting the input of all but the most well-connected compa...
  • FDA Announces Major Funding for WHO to Support Regulatory Capacity, Harmonization

    US regulators have announced a five-year, multimillion-dollar contract with the World Health Organization (WHO) intended to support regulatory science and enhance global regulatory capacity through improved harmonization and the development of standards. The Office of International Programs The funding opportunity is made available through FDA's Office of International Programs (OIP), now headed by John Taylor, acting deputy commissioner, and Mary Lou Valdez, associat...
  • Medical Device Industry Comes Together to Slam Proposed Regulation on Clinical Trials

    The medical device industry is none too pleased with a proposed regulation released in February 2013 that would require all companies to make sure their clinical trials, no matter where in the world those trials are conducted, to adhere to US clinical trials regulations. Background The US Food and Drug Administration's (FDA) draft regulation, Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices , would notably require sponsors to o...
  • OECD Calls for Regulatory Harmonization to Support Global Clinical Trials System

    The Organization for Economic Co-operation and Development (OECD), a long-standing global governance group focused on economic issues, has called for countries around the globe to harmonize their clinical trials regulations in an attempt to save both costs and lives. Background In a statement, OECD said it was troubled by "increasingly complex and inconsistent clinical trial regulations," which it said were causing delays, increasing costs and leading to fewer clinical ...
  • GHTF Says Final Goodbyes, Shutters Website

    So long, Global Harmonization Task Force (GHTF). The global medical device harmonization body has finally disbanded, leaving its unfinished work to the International Medical Device Regulators Forum (IMDRF), a successor organization comprised of officials from regulatory agencies-not industry-around the world. The organization had been a mainstay among the regulatory harmonization movement. Formed in 1992 by EU, US, Japanese, Australian and Canadian regulatory and industr...
  • IOM Calls for Regulatory Harmonization

    • 28 November 2012
    The Institute of Medicine (IOM) wants the practice of regulatory affairs to be a little bit easier, particularly for low-resource countries and companies conducting international clinical trials. In an announcement on 28 November 2012, the prestigious healthcare agency said it plans to hold a meeting on regulatory harmonization, the process by which countries and organizations standardize their regulatory processes. IOM has long been interested in regulatory topics. W...
  • ICH Working Group Calls for Revisions to Q7 Guideline

    The International Conference on Harmonisation (ICH) has published a new concept paper regarding the standardized regulation of good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs), the first step in reforming the organization's Quality 7 (Q7) Guideline. The paper, endorsed by ICH's Steering Committee in October 2012 and released in November 2012, refers to the widely-used Q7 GMP Guidance for APIs , released in November 2000. The document, I...
  • Feature ArticlesFeature Articles

    Harmonizing Drug Regulations in the Gulf Region

    Currently, approximately 20% of countries globally have fully operational pharmaceutical regulations. Of the remainder, half have regulations of varying capacity and 30% have either very limited or no drug regulation. The reality is many developing countries cannot ensure the safety, efficacy and quality of medicines available on their markets because of limitations in staffing, standard systems and training. 1 Conversely, in developed countries where resources are les...
  • RAPS' LatestRAPS' Latest

    Regulators, Industry Discuss Potential Impact of IMDRF

    The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body, but you wouldn't know it by looking at its membership or its ambitions. The organization, launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), sports an impressive array of members for an organization in its infancy: the US Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), Brazil's Nationa...
  • Asian Regulatory Harmonization Plan Calls for Investments in Regulatory Capacity

    The Asian Harmonization Working Party (AHWP), a standards harmonization group focused on medical devices, has released a strategic framework and two proposed standards for public comment. The group, established in 1999, includes 23 countries across Asia, Latin America and the Middle East and now considers itself the, "Largest medical device regulatory harmonization body in the world." The group's forward-looking strategic framework, which it bills as the " Strategic Fra...
  • US, Canada Announce Extensive New Harmonization Efforts

    The White House's Office of Management and Budget (OMB) has announced the next stage in a regulatory harmonization agreement first launched in early May 2012 between the US and Canada, with life science regulations expected to enter into a process of harmonization between the two countries. The 30 July announcement by OMB includes four regulatory areas scheduled for harmonization: an electronic submission gateway, common monographs for over-the-counter (OTC) drugs, g...
  • FDA Adopts ICH Guidance on Pharmaceutical Quality

    The US Food and Drug Administration (FDA) released new guidance on 25 July for industry regarding three quality documents released by the International Conference on Harmonization (ICH) related to how manufacturers and sponsors can best prepare these documents for inspection by regulators in the US, EU and Japan. The guidance is co-sponsored by FDA's Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), both of which are in charge ...