International Regulatory Harmonization Amid Globalization of Drug Development Workshop Summary (2013) / Chapter Skim
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1 Introduction
1 Introduction
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Additionally, biopharmaceutical companies seeking global markets need to submit applications for approval of a given product to the regulatory authorities of many different countries, each of which could introduce scientific requirements discordant with those of the manufacturer's home market. Differing data requirements across countries may necessitate additional clinical trials and animal studies, increasing the cost of potentially important medicines and slowing patient access to them.
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. The forum maintains a sustained focus on the need for improving the clinical trials enterprise to support more efficient and effective new drug development, including holding two public workshops exploring approaches to clinical trial transformation; see Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary (IOM, 2010)
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fore deemed the regulatory system to be a key factor in public health safety. The committee further noted that the regulatory authorities in low- and middle-income countries often cannot perform all of the necessary responsibilities and asserted "The FDA cannot do its job well without substantive improvements in the capacity of its counterpart agencies in emerging economies." Specifically, the committee called for the sharing of inspection reports as an important first step in mutual recognition and international regulatory harmonization.
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Bollyky, Council on Foreign Relations The co-chair of the IOM's Forum on Drug Discovery, Development, and Translation and workshop co-chair Steven K Galson, Global Regulatory Vice President, Amgen Inc., emphasized the forum's function as an ongoing neutral place where stakeholders in government, academia, industry, foundations, consumers, and patient groups meet to discuss and confront issues of mutual interest and concern, including the most pressing problems in critical areas of drug development.
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Honig stated that harmonization facilitates the expansion of clinical trial activity. When researchers use clear, shared standards, he said, it is easier for regulators to accept multiregional trial data for their country.
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Furthermore, either rules or common expectations may be needed regarding the handling of trial data and when to disclose them. Recent annual growth rates in clinical trial participation in many nonWestern countries have been in the double digits.
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, which has advanced considerably, manufacturers had to seek registration approval for their products in Europe, one country at a time. Now, centralized BOX 1-2 Selected International Harmonization Effortsa • nternational Conference on Harmonisation of Technical Requirements for I Registration of Pharmaceuticals for Humans (ICH)
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New kinds of therapies, biological products, and dosage forms, and an increased industry focus on lifecycle management -- from a product's inception in the laboratory to the end of its patent life -- will likely be on the ICH agenda in the future, said Honig. Challenges for Existing Harmonization Initiatives A large gap in regulatory capacity and expertise between emerging and developed countries remains, said Honig.
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175) further stated, "Although the reasons for this innovation deficit 6 Thissection is based on the presentation by Hubert Leufkens, Chair, Dutch Medicines Evaluation Board, and Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University for Pharmaceutical Sciences.
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Diagnosis of psychiatric conditions varies from one country to another 2. In oncology, use of overall survival rates versus progression-free survival as endpoints; or in diabetes, the use of blood glucose levels versus or in addition to other measures, with an increas ing preference for clinical outcome measures, rather than simple biomarkers 3.
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. Similarly, a study of differences in regulatory actions by FDA and the European Union related to biologicals appeared at first to suggest these differences were quite large, but further analysis indicated that clinically relevant differences were much smaller (Giezen et al., 2008)
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