HARMONISATION OF PHARMACEUTICAL REGULATIONS

KUALA LUMPUR, Aug 18 (Bernama) -- The Pharmaceuticals Product Working Group
has developed an Asean Common Technical Dossiers (ACTD) and Asean Common
Technical Requirements (ACTRs).

This is to enable the group, chaired by Malaysia, to harmonise
pharmaceutical regulations in Asean to facilitate trade in pharmaceuticals.

The health ministry's Centre for Product Registration (National
Pharmaceutical Control Bureau) deputy director Abida Syed M. Haq said the ACTD
covered administrative data, quality, safety and efficacy.

The ACTRs involved quality, safety and efficacy.

"With all these initiatives in place, it is highly likely that a greater
harmonisation in regulatory regimes will be seen in the near future which will
lead to the ultimate goal of timely access to medicines which are safe,
efficiacious and of quality," she said when presenting a paper at the 3rd Annual
Series-Asia Healthcare 2009 here Tuesday.

The paper entitled 'Updates and Emerging Regulatory Challenges-Capitalising
on new Regulatory Regimes in the Asian Pharmaceutical and Medical Markets' was
delivered at the two-day event organised by the Asian Strategy and Leadership
Institute (ASLI).

The Pharmaceuticals Product Working Group was established in 1999 and it is
co-chaired by Thailand.
-- BERNAMA