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Regulatory Focus™ > News Articles > Emerging Markets: The ASEAN Harmonization Scheme: Another CTD—Another Challenge to the Industry

Emerging Markets: The ASEAN Harmonization Scheme: Another CTD—Another Challenge to the Industry

Posted 01 November 2008 | By

In keeping with the trend toward international and regional trade cooperation, several regional pharmaceutical harmonization initiatives have been developed to establish cooperation among involved countries to minimize efforts and speed their access to new medicines. A typical harmonization initiative for the regulation of drug registration is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), a tripartite collaboration of the regulatory authorities of Europe, Japan and the US. Non-ICH countries also have expressed the need to develop a harmonization process, which has resulted in the formation of these regional harmonization initiatives. One of the most successful and effective is the ASEAN harmonization initiative. ASEAN means Association of Southeast Asian Nations and includes 10 member states: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. ASEAN was established in 1967 to promote regional economical unity and cooperation by establishing the ASEAN Free Trade Area1 (AFTA). The strategic ASEAN partnership has led to a pharmaceutical harmonization initiative that complements and facilitates the objectives of AFTA by enforcing cooperation in the area of public health and developing a harmonization scheme of pharmaceutical regulations for ASEAN member countries.

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