TRENDS AND CONSIDERATIONS IN GLOBAL CARDIOVASCULAR DRUG DEVELOPMENT | Page 11

offsets slower start-up and overall research timelines are often shorter in
emerging countries. For countries such as India and China that have many
languages and dialects, regulations that require regulatory documents in multiple
languages can involve significant time and cost.
Harmonized regulatory pathways are being established in some regions including
Asia and Latin America. Most Latin American countries comply with the
“America’s Document” issued by the Pan American Network for Drug Regulatory
Harmonization (PANDRH).

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The 10 member nations of ASEAN (Association of

Southern Asian Nations), which includes Singapore, the Philippines and Thailand,
are evolving common research standards and have established the ASEAN
Common Technical Document.

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The ASEAN-China Free Trade Agreement

comprises the world’s largest trading block of over 2 billion people.
Standards of Care Considerations. Varying standards of care impact study
outcomes and special care must be taken to ensure consistency across
international sites. Sponsors must address varying standards of care when
selecting comparator drugs and when designing trials that will evaluate new CV
agents used in addition to standard of care therapy.