Application Forms Biologics

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Document Name MS Word PDF Updated
GLP Compliance Form Download   15 May 2024
Checklist for Manual Submission Download   23 July 2024
CGTPs Stage I & II Manual Screening Form Download   9 June 2022
Appendix 1 (Format for Clinical Studies Conducted/Ongoing/Planned in Malaysia); Appendix 2 (Format for Synopsis of Individual Studies) Download   2 May 2024



National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400




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