Information

This barrier is unrelated to the end of the transition period, following the United Kingdom's departure from the EU.

Public ID: PID-9JK4WB

Delays for drug approvals

in Malaysia

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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