Delays for drug approvals
Trade barrier summary
Stringent drug approval requirements shortens the period patent protection applies. This approval process is overseen by Malaysia's Drug Control Authority. It can cause delays of around 12 months.
Requirements include:
1. Providing raw data upfront.
2. Registration of active pharmaceutical ingredients.
3. Good manufacturing practice (GMP) inspections of Non-Pharmaceutical Inspection Co-operation Scheme member countries for new drug registrations.
Sectors affected
- Pharmaceuticals and biotechnology
Resolved
No
Date reported
23 May 2019
Last updated
19 July 2022
Public ID
PID-9JK4WB
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