Direktif untuk menerima permohonan Lesen Import Percubaan Klinikal (CTIL) dan Kebenaran Mengilang Produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX) bagi produk biologik (kecuali produk Cell And Gene Therapy) yang melibatkan kajian klinikal First-in-Human (FIH)

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National Pharmaceutical Regulatory Agency (NPRA)

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

  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

 

 

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