International Regulatory Harmonization Amid Globalization of Drug Development Workshop Summary (2013) / Chapter Skim
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6 Finding Solutions: Options and Systemic Approaches
6 Finding Solutions: Options and Systemic Approaches
Pages 57-66
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From page 57... ...
LEGAL FRAMEWORK Numerous times in this workshop the existence of a common legal (and economic) framework in the European Union was cited by par 1 This chapter is based on brief presentations made by a reactor panel that included Vincent Ahonkhai, Deputy Director, Regulatory Affairs, BMGF; Raymond Chua, Group Director, Health Products Regulation Group, Singapore Health Sciences Authority; Mary Lou Valdez, Associate Commissioner, International Programs, and Director, Office of International Programs, FDA; David Wood, Coordinator, Quality, Safety and Standards, WHO; and discussions of workshop participants.
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From page 58... ...
"It is the duty of regulators to use creativity and leadership, not to worry about their statutory authority." For example, he noted, some of FDA's most important harmonization efforts were not created by statute or were legislated after the regulators invented them. COOPERATION AND COLLABORATION Raymond Chua, Group Director, Health Products Regulation Group, Singapore Health Sciences Authority, noted that in the drug regulatory field, PIC/S2 has developed an informal cooperation scheme which aims to encourage member states to recognize each others' inspections, harmonize good manufacturing practice requirements, train inspectors, exchange information, and engender mutual confidence.
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From page 59... ...
Beyond sharing information across agencies, several workshop participants suggested that increased discussion and collaboration with manufacturers might lead to the industry's better understanding of a country's biomedical product needs, and the regulators' better understanding of the policies and practices that would support the companies that are developing these priority products. One example of a regulatory action supporting industry would be harmonized clinical trial regulations for multinational research.
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From page 60... ...
CAPACITY BUILDING Not every country can have the staff and other resources of the world's largest biomedical products regulatory agencies. Although the relatively well-resourced agencies have a different scope of problems than lower income countries, they are reaching out to help build capacity elsewhere.
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From page 61... ...
In a broad sense, the kind of capacity needed is capacity for collaboration, cooperation, and understanding of the global regulatory situation. Capacity building per se does not solve the problems, said Rägo, "You have to know capacities for what and where and when." BUSINESS CASE Although the benefits of international harmonization of medical products regulation may be clear to experts in the field, these benefits are not as clear to everyone else, said Wood.
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From page 62... ...
Valdez emphasized the need to develop a business case that demonstrates how key actions discussed at the workshop -- such as ensuring supply chain integrity, data transparency, data sharing, pharmacovigilance, and use of science-based standards -- would save money and increase the efficiency of regulators and industry alike. While regulators' strength is in leading with the science, she said, they do not do especially well in making an economic argument.
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From page 63... ...
Nasr, Vice President, CMC Regulatory Strategy, GlaxoSmithKline, asked, "Is it to micromanage and evaluate development and manufacturing, or is it to assure quality, safety, and efficacy? " Focusing on the key regulatory functions perhaps needs to precede moving into harmonization, he said,
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From page 64... ...
Compared to regulatory or legislative changes, standards and guidelines would be easier to achieve, as of now, because they do not intrude on national sovereignty rights. ICAO has approached this by setting mandatory global minimum standards, and the biomedical products industry could do the same, with the addition of a second set of standards that responds to any specific local or regional needs.
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From page 65... ...
It engages in many activities that parallel those of drug regulatory authorities: determining priorities, developing policies and standards, coordinating global monitoring, delivering targeted assis tance, and building capacity. Its planning work -- from the global safety level down to regional and national safety plans -- is based on high-level principles accepted by industry stakeholders.
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From page 66... ...
Chua summarized the steps needed as the six Cs: commitment, convergence, communication, cooperation, collegiality, and capacity. In addition to Chua's comments, various individual workshop participants had the following insights about moving forward with harmonization: • Progress requires two essential preconditions: developing strategic and more structured regulatory frameworks and creating a safe space for discussion.
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