Snapshot

The FRP- Reliance (Abbreviated Review) pathway has been developed by the National Pharmaceutical Regulatory Agency of Malaysia.

This pathway can be used where new drug products, generic medicines and biologics including cell and gene therapy products (CGTPs)..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from ASEAN Australia Brazil Canada China EU-EMA Japan Mexico Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States WHO

Target time assessment is 90 working days. Screening and correspondence (applicant time) are not included in the timeline..