Regulatory bottlenecks such as local QC testing and pre-approval of GMP inspections must go

The APAC pharma and biopharma landscape is rapidly evolving and the market access landscape is increasingly turning complex with the intricate regulatory system.

- Hithaishi C Bhaskar

Eileen Ang, Head of Regulatory Affairs, Takeda APAC

Companies in APAC deal with rapidly changing risk and compliance challenges to remain competitive in the market. While identifying opportunities and roadblocks, it's essential to sharpen regulatory landscape conditions, encourage government initiatives, and nurture the regulatory ecosystems for harmonisation and bilateral relations that can close-nit the markets. Eileen Ang, Head of Regulatory Affairs, Takeda APAC shares the latest APAC regulatory ecosystem insights while navigating through Asia-Pacific markets to understand trends, requirements, and regulations. Edited excerpts;

Can strategic regulatory reforms empower a company to mitigate market access risks to promote its commercialisation, trade, and investment capabilities?

Regulatory agencies should continue working towards harmonising their guidelines with internationally recognised standards or move towards regulatory convergence whereby regulatory requirements become more aligned over time through the gradual adoption of internationally recognised technical guidance documents and standards. Flexibility should be adopted to allow for reliance on or recognition of the assessments already performed by stringent authorities such as the US FDA and EMA in order to accelerate product approvals. Regulatory bottlenecks such as local QC testing and pre-approval Good Manufacturing Practices (GMP) inspections should be removed.