The ASEAN CTD (ACTD)

Not only has the (e)CTD taken hold in Europe, North America, Japan, and Australia, but it even has given rise to some pseudo-CTD standards. Many of us have heard about the NeeS standard being used in Europe by some agencies to accept eSubmissions in cases where either the sponsor or regulator can't (or won't) yet accept eCTDs.

The ASEAN (Association of Southeastern Asian Nations) have observed this and are now drafting the ASEAN CTD, a standard derived from the CTD.

So, what does it look like? Well, it's similar to the CTD, but a little off. In place of the 5 modules, the ACTD organized the submission into 4 parts. This is done because ASEAN members usually only receive reference applications -- applications to put a drug on the local market that has already been approved elsewhere. As a result, the need for detailed documentation is lessened -- most study reports are not required to be submitted.

Module 1 in the CTD (the regional and registration information) is still present as Part I in the ACTD. ICH M2 is dropped and the summaries are absorbed into the subsequence parts. Quality information (ICH M3) is Part II of the ACTD, Nonclinical (ICH M4) is Part III, and Clinical (ICH M5) is Part IV. The comparison pyramids below should give a rough idea of the differences.


Further reading is available on other online sources -- a good starting point is searching "ACTD" at the Singapore HSA website...especially for English speakers. :)

So, why should drug companies consider the ACTD as a part of their global regulatory operations? Well, as this presentation by Hunton & Williams alludes to, the economic benefits of free trade between ASEAN nations and Europe (and presumably North America as well) could be huge (Powerpoint presentation here).