Regulatory and compliance challenges for local and regional manufactures in the ASEAN

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In general there are three types of players in the ASEAN regulated healthcare industries who have differing compliance concerns, for simplification we have named these; Locals, Regional Leaders and Multinationals. In the ASEAN region there are few Multinationals operating manufacturing sites with the exception of Singapore which through aggressive targeting of the industry in providing heavy tax incentives has become the regional base for many of the Multinationals. Out of the other countries then Indonesia has passed legislation in order to require international Pharmaceutical companies to have an operations presence in the country and recently there are signs that point to the larger international and Japanese manufacturing firms returning to setting up facilities in ASEAN.

This article looks at the Regional Leaders:

These companies are ASEAN owned and much more externally driven and focused on growing overseas markets than their Local competition. All of these players grew strongly in their home markets and in some cases are competing on a large revenue basis, comparable now to international levels and the developed South Korean companies.  As differentiation is important to becoming a leader at home and in new locations aboard then The Regional Leaders tend to specialize in more complex processes and dosage forms. Sterile products are typically produced by the more dynamic companies in ASEAN and their products are increasingly exported from the region to Europe, Japan and even the US. The Regional Leaders must and do actively pursue standardization such as PIC/S compliance as this is their ‘passport’ to travel and a very important enabler of future growth both locally regionally and internationally. They consider that the playing field of standardization has yet to be leveled as many of their Local competition may not have invested as heavily in compliance as they have done, thus then often The Regional Leaders are pushing their respective Authorities to harden the application of regulatory requirements in audits and inspections. One of the key compliance needs for these companies is to have access to competent experts in their specialist areas, so there is a demand for international consultants to provide expert help that the Regional Leaders need in order to fulfill the newer GMP and technical requirements.