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The Elusive Single-Point-of-Entry


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-05-01-2011
Volume 0
Issue 0

Considering Big Pharma's trade objectives, the success of regional regulatory harmonization is not insignificant

With Malaysia's local manufacturers and Big Pharma increasingly looking to trade in the ASEAN Economic Community, the success of regional regulatory harmonization is not insignificant. Disparities in regulatory frameworks continue to create obstacles for both international and regional companies entering the region's markets. Cheah Chor Eng, country manager of Invida Malaysia, says that "while there are multilateral steps being taken by the ASEAN leaders towards regional harmonization ... this desired state is still a number of years off." However, with Asia leading the global economic growth, the time to invest is now.

Cheah Chor Eng, Malaysia Country Head, Invida Malaysia

Local Malaysian manufacturers pay a penalty when entering the more capricious regulatory environments of their neighbors. the Malaysian Organisation of Pharmaceutical Industries (MOPI) confirmed that that the "protectionist standpoint of other ASEAN members" dramatically reduced the size of this export market to the AEC. Multinationals have also faced a number of sales compliance issues when navigating these diverse regulatory systems. Within ASEAN, only Singapore and Malaysia seem fully engaged in the harmonization process, having signed a Mutual Recognition Agreement (MRA) for their GMP production facilities. The MOH is energetically collaborating with the Pharmaceutical Products Working Group of the AEC to improve trade conditions and harmonize procedures. In the meantime, marketing and distribution companies such as Invida will continue to be seen as what Cheah calls a "gateway to Asia Pacific for companies looking to grow their footprint in the region."

Sinclair Pharma's CEO Chris Spooner (left) and Invida Group's CEO John Graham after signing a long-term collaboration agreement where Invida would be Sinclair's exclusive partner in Asia Pacific

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