1 THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ORGANIZATION OF THE DOSSIER PREAMBLE This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD)...
Registration of pharmaceutical products is a challenge and an important task in regulated, semi regulated as well as rest of the world countries. Although the requirements are harmonized in regulated countries byCommon Technical Document (CTD) filing, yet others have enormous diversity in requirements....
The ASEAN Common Technical Dossier (ACTD) was created with the aim to serve as a harmonized guideline for pharmaceutical product registrations in the ASEAN countries. The use of a common format is intended to simplify the registration process and reduce the time and resources needed to put togeth...
The most common structures are various types of public-private partnership (PPP) such as build-operate-transfer (BOT) arrangements. For emerging ASEAN countries, MDB involvement is likely needed. Increasingly, green bonds and "infrastructure bonds" have been issued to attract capital market investors...
b)To promote active collaboration and mutual assistance on matters of common interest in the economic, social, cultural, technical, scientific and administrative fields; c)To collaborate more effectively for the greater utilization of their agriculture and industries, the expansion of their trade, inclu...
Tackling regional water challenges for common prosperity and sustainable development throughout the six countries constitutes the strategic basis for Lancang-Mekong water resources cooperation. China Report ASEAN: During the two LMC summits, what requirements did leaders insist on for water resources ...
Task Force (GHTF) guidance document titled “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)” (Document number: SG1/N011R17). The ASEAN CSDT document is intended to provide a common template for the ...
ASEAN has paddled against global currents in 2018 to offer hope that multilateral initiatives will continue to bring states closer together on common objectives. But trade tensions between ASEAN’s two largest partners — the United States and China — continue to concern the region. Progress on ...
HAVINGregardtotheprinciplesofharmonisationofmedicaldeviceregulations,theharmonisedcommontechnicaldocumentsandtheprogressmadeinitsimplementation HAVEAGREEDasfollows: ARTICLE1 GENERALPROVISIONS 1.MemberStatesshallundertakeallnecessarymeasurestoensurethatonlymedicaldeviceswhichconformtotheprovisionsofthisASEANAgreementonMedicalDevi...
Regional peace and stability through abiding respect for justice and the rule of law in the relationship among countries of the region Collaboration and mutual assistance on matters of common interest in the economic, social, cultural, technical, scientific, and administrative fields Mutual assistance t...