International Regulatory Harmonization Amid Globalization of Drug Development Workshop Summary (2013) / Chapter Skim
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3 Overview of the Current Global Regulatory Landscape
3 Overview of the Current Global Regulatory Landscape
Pages 23-34
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ICH1 Toshiyoshi Tominaga, Professor and Director, Food and Drug Evaluation Center, Osaka City University Hospital, began by describing ICH, an initiative cosponsored by the drug regulatory agencies and pharmaceutical manufacturing associations of the following organizations: • Europe (EU/EMA, EFPIA [European Federation of Pharmaceutical Industries and Associations]
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The common technical document includes guidance on formatting trial datasets and data elements, which facilitates review and enables industry to submit its data to different regulatory authorities in a single format. As an example of a completed guideline, Tominaga described guideline Q1A, "Stability Testing of New Drug Substances and Products," which specifies the temperature and humidity conditions under which a drug should be stored in order to demonstrate its stability over different time periods.
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PANDRH3 Drug regulatory harmonization initiatives in Latin America cannot be discussed without reference to broader harmonization initiatives in the Americas and the broader global context. Many regulators in the Latin American region participate in these broader efforts, according to James 3 This section is based on a presentation by James Fitzgerald, Coordinator, Medicines and Technologies, Area of Health Systems based on Primary Health Care, Pan American Health Organization (PAHO)
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. Since then, the mission has evolved, and the organization now also takes into account some of the asymmetries within the region of the Americas, recognizing that there are many well-established national regulatory authorities and some strongly developing ones, as well as some low-income countries that do not have robust regulatory capacity and are not prioritizing harmonization efforts at present.
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At present, however, there is some empirical evidence regarding impact. For example, Fitzgerald pointed out that Technical Document 6, which covers self-evaluation of good laboratory practices, has been implemented by 21 countries; 20 countries have adopted the norms in the document covering pharmacovigilance; and the vaccine common technical document is being implemented partially in 14 countries and completely in 7.
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These regulators have suggested that PANDRH begin to look at convergence by linking its normative processes, which focus on technical harmonization, while building on established capacity within the national regulatory authorities. Accordingly, noted Fitzgerald, PAHO member states adopted a resolution in 2010 to strengthen national regulatory authorities for medicine and biologicals.
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APEC MEMBER ECONOMIES4 APEC was created in 1989 and includes 21 member economies, which account for 40 percent of the world's population, 54 percent of its gross domestic product, and 44 percent of its trade. APEC includes Australia, Canada, China, Japan, Korea, Russia, the United States, and many smaller economies.
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APEC is working to establish official liaisons with other international harmonization initiatives, said Ward, because of the belief that it needs to act as a catalyst for international action on issues that demand a global approach, such as supply chain integrity. APEC's strategic framework outlines a multiyear approach for achieving greater regulatory convergence by 2020; describes guiding principles and the steps necessary to achieve that end; and accommodates different countries' pace.
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The plan's aim is to contribute to a sustainable supply of quality essential medicines to improve public health and promote industrial and economic development on the continent. Regulatory harmonization is seen as a critical factor in facilitating local production of pharmaceuticals, said Ndomondo-Sigonda, ensuring a sound regulatory environment, and encouraging intra- and intercontinental trade.
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Setting priorities for action has taken into account that 54 national regulatory agencies are involved in this effort: each of them works independently and may lack adequate medicines policies and laws; have different requirements and formats; vary in regulators' capacity; operate with minimal transparency; have no clear time lines; and make little to no use of reference evaluations conducted by more stringent national medications review authorities. Because of the severe challenges regulators face, AMRH's first priority for action is to harmonize medicines registration requirements and standards.
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At the continental level, AMRH working groups also have formed, for example, around regulatory capacity development, medicines policies, and regulatory reforms. In July 2012, the AU assembly endorsed a roadmap for shared responsibility on key infectious diseases that emphasized the need to accelerate and strengthen harmonization initiatives and, more important, laid the foundation for a single African medicines agency.
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