International Regulatory Harmonization Amid Globalization of Drug Development Workshop Summary (2013) / Chapter Skim
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4 Areas of Need for Harmonized Standards and Barriers to Progress in Addressing the Gaps
4 Areas of Need for Harmonized Standards and Barriers to Progress in Addressing the Gaps
Pages 35-48
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, FDA, began his presentation by summarizing the current environment for drug regulatory harmonization. He said harmonization is occurring across a wide range of activities, from regulatory policies to technical standard setting.
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Here, consistent standards of data collection, access, and storage would enable much greater efficiencies, more robust research, and expanded pharmacovigilance. Gaps in information about how FDA's regulatory structures work are addressed in CDER's Forum for International Drug Authorities.
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GAPS FROM THE PERSPECTIVE OF NONGOVERNMENTAL ORGANIZATIONS, FOUNDATIONS, AND PRODUCT DEVELOPMENT PARTNERSHIPS2 Based on his experiences, Vincent Ahonkhai, Deputy Director, Regulatory Affairs, Bill & Melinda Gates Foundation (BMGF) , has a perspective that combines the views of both the private and public sectors.
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In clinical trials, he cited the African Vaccine Regulatory Forum (AVAREF) , the European and Developing Countries Clinical Trials Partnership, and the Critical Path to Tuberculosis (TB)
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Qualification of Innovative Development Methods and Drug Development Tools4 Martha A Brumfield, Director, International and Regulatory Programs, C-Path, identified the following key issues discussed by participants in this breakout group: 4 This subsection is based on the presentation by Martha A
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Under Europe's Marketing Authorization Applications process (equivalent to FDA's NDAs) , Brumfield noted that manufacturers may receive scientific advice from the EMA.5 If this advice pertains to use of 5 "Scientific advice is when the [EMA]
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, identified the following key issues discussed by participants in this breakout group: • Increasing requirements by regulatory authorities of different countries for minimal proportional representation of subjects from the home country in multiregional clinical trials pose difficulties. Liberti said the discussion of the topic centered on whether such requirements reflect real scientific and clinical concerns or whether in some cases they are motivated by political factors or a lack of confidence in other countries' data.
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premarketing safety reporting requirements. Clinical Trials In addition to occasional cultural differences and language barriers that impede the smooth operation of multiregional trials, Ball noted the discussion of numerous bureaucratic obstacles, including 7 This subsection is based on the presentation by Leslie Ball, Assistant Commissioner, International Programs, and Deputy Director, Office of International Programs, FDA.
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Third, at the study site level, additional barriers may arise -- for example, sites may lack sufficient capacity to carry out the trial, a problem more likely to arise when the trial involves neglected diseases or takes place in developing countries. In addition, she noted there may be specific programmatic complications, such as differing requirements for pediatric drug development, which may encounter barriers at all three levels.
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Postmarket Safety Surveillance9 Andy Stergachis, Professor of Epidemiology and Global Health, Adjunct Professor of Pharmacy, Director, Global Medicines Program, School of Public Health, University of Washington, identified the following key needs discussed by participants in this breakout group: • Strengthen capacity around postmarket safety surveillance before attempting harmonization and convergence, but with those factors in mind. • Bring more countries into ICH.
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Manufacturing Standards and Process10 Diane Zezza, Vice President, Global Regulatory CMC, Novartis Pharmaceuticals Corporation, stated that the breakout discussion focused on two key areas: CMC reviews and good manufacturing practices. CMC Reviews Zezza stated that members of this breakout group began their identification of challenging areas of non-harmonization for industry, regulators, and patients with the lack of harmonization of dossier content.
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Some countries require additional import testing, and unexpected results may affect the supply of a product or trigger recalls. Zezza noted that individual suggestions for ways to tackle these problems, short of a centralized global filing procedure, included • development of mutual recognition agreements for dossier review and approval of CMC content; • assessment of whether WHO's Certificate of Pharmaceutical Prod uct process might evolve to include CMC reviews; and • application of the fundamental principles of the QBD paradigm in an effort to reduce postapproval changes, acknowledging that the QBD approach has not yet achieved its full potential.
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She noted potential opportunities to extend ICH's success in the manufacturing arena by persuading all countries to commit to implementing its common data requirements and by linking the ICH guidances to trade agreements. In the developing countries, the existence of multiple, non-harmonized pharmacopeias creates a persistent challenge.
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