18 May 2016, Siem Reap, Cambodia
GaBI organized the Second Asia-Pacific Roundtable on Non-Biological Complex Drugs on 18 May 2016 in Siem Reap, Cambodia in collaboration with the ASEAN ACCSQ-PPWG.
The Second Asia-Pacific Roundtable on Non-Biological Complex Drugs is a thought-leadership roundtable on non-biological complex drugs (NBCDs) for regulators who are key representatives (heads of delegation) from ASEAN ACCSQ–PPWG Member States from Cambodia, Indonesia, Lao PDR, Myanmar, Philippines, Thailand, Vietnam to discuss and exchange viewpoints with experts from Europe and the US to identify the need for a reflection or guidance on how to evaluate such nanosimilars and NBCD follow-ons to provide safety and efficacy of treatment. Eighteen participants, speakers included, attended the meeting.
The meeting focused on regulatory assessment principles. An open discussion session on informal debate of a harmonized ASEAN guidance on regulatory evaluation of follow-on NBCDs and to identify applicable measures was held during the meeting.
You can download the speakers’ presentations of this roundtable meeting:
An EDQM view on characterization of non-biological complex drugs
Generic or follow-on versions of small molecules and large molecular complexes
FDA and EMA: regulatory situation of NBCDs
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