BPFK - CIRCULARS

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CIRCULARS

Circulars - BE
Makluman Susulan Berkaitan Kajian Bioekuivalens bagi Produk Generik Immediate Release Oral Solid Dosage Form yang Bertukar Tapak Pengilangan (620.10 KB pdf)
Direktif Guidance on Biopharmaceutics Classification System (BCS) – Based Biowaiver (302.32 KB pdf)
Direktif Untuk Mewajibkan Penghantaran Notifikasi Oleh Pihak Penaja / Pusat Kajian Bioekuivalens (BE) Kepada BPFK Bagi Semua Kajian BE Yang Tidak Memerlukan Lesen Import Percubaan Klinikal / Kebenaran Mengilang (CTIL/CTX) (1.11 MB pdf)
Bioequivalence Study for Generic, Immediate Release, Oral, Solid Dosage Form Submitted as a Second Source - 2 Jun 2011 (234.71 KB pdf)
Bil (10) dlm BPFK/PPP/01/03 Jld 1 (All generic, immediate release, oral, solid, dosage form containing scheduled poison) - 2 Mac 2011 (1.23 MB pdf)
Bil(8)dlm BPFK/PPP/01/03 Jld 1 (9th list) - 10 Januari 2011 (4.57 MB pdf)
Bil(46)dlm BPFK/PPP/01/03 - 30 Oktober 2009 (1.31 MB doc)
Bil(25)dlm BPFK/PPP/01/03 - 11 Februari 2009 (364.32 KB jpg)
Bil(38)dlm BPFK/PPP/07/1 (7th list) - 6 Ogos 2008 (1.14 MB pdf)
Bil(5)dlm BPFK/PPP/01/03 - 26 Jun 2008 (150.27 KB pdf)
Bil(63)dlm BPFK/02/5/1.3 (6th list) - 15 Ogos 2006 (1.51 MB pdf)
Bil(51)dlm BPFK/02/5/1.3 (kajian semula) - 26 Julai 2005 (848.91 KB pdf)
Bil(85)dlm BPFK/007/3.8 (5th list) - 18 Mac 2004 (350.09 KB pdf)
Bil(85)dlm BPFK/007/3.8 (4th list) - 14 Jun 2002 (420.35 KB pdf)
Bil(50)dlm BPFK/007.3.8 (3rd list) - 8 Mei 2001 (10.64 KB pdf)
Bil(85)dlm BPFK/007.3.7 (2nd list) - 14 Februari 2000 (7.95 KB pdf)
Bil(50)dlm BPFK/007/3.7 (1st list) - 23 Februari 1999 (268.66 KB pdf)
Direktif Penguatkuasaan Keperluan Kajian Bioekuivalens bagi Semua Produk Generik - Immediate Release, Oral, Solid Dosage Form - yang Mengandungi Bahan Aktif Racun Berjadual Serta Akreditasi Pusat Kajian Bioekuivalens (1.23 MB pdf)

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Click the following circulars to view or download:

1. Bil(50)dlm BPFK/007/3.7 (1st list) - 23 Februari 1999 (269 KB, PDF)

2. Bil(85)dlm BPFK/007.3.7 (2nd list) - 14 Februari 2000 (8 KB, PDF)

3. Bil(50)dlm BPFK/007.3.8 (3rd list) - 8 Mei 2001 (11 KB, PDF)

4. Bil(85)dlm BPFK/007/3.8 (4th list) - 14 Jun 2002 (421 KB, PDF)

5. Bil(85)dlm BPFK/007/3.8 (5th list) - 18 Mac 2004 (351 KB, PDF)

6. Bil(51)dlm BPFK/02/5/1.3 (kajian semula) - 26 Julai 2005 (849 KB, PDF)

7. Bil(63)dlm BPFK/02/5/1.3 (6th list) - 15 Ogos 2006 (1550 KB, PDF)

8. Bil(5)dlm BPFK/PPP/01/03 - 26 Jun 2008 (151 KB, PDF)

9. Bil(38)dlm BPFK/PPP/07/1 (7th list) - 6 Ogos 2008 (1166 KB, PDF)

10. Bil(25)dlm BPFK/PPP/01/03 - 11 Februari 2009 (365 KB, JPG)

11. Bil(46)dlm BPFK/PPP/01/03 - 30 Oktober 2009 (1341 KB, WORD)

(Updated: August, 2009)

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