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Guidelines for Clinical Trial

20th Mar, 2024
Application Form - Clinical Trial

Document Name	Updated
Malaysian Guidelines for Good Clinical Practice 4th Edition	Jan-18
Malaysian-Guideline-for-Application-of-CTIL-and-CTX-8th-Ed-Final (Effective on 30 April 2024)	Mac-24
Malaysian-Guideline-for-Application-of-CTIL-and-CTX-7.1-Edition	Sept-21
Guidelines for Good Clinical Practice (GCP) Inspection, Edition 2.1	Dec-20
Malaysian Guideline for Phase I Unit Inspection and Accreditation Programme	Jun-18
Malaysia Guideline for BE Inspection, First Edition	Oct-14
Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First Edition	Jun-16
Malaysian Guideline for Safety Reporting of Investigational Products	Oct-14

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weixin updated an article

Guidelines for Clinical Trial

20th Mar, 2024
Application Form - Clinical Trial

Document Name	Updated
Malaysian Guidelines for Good Clinical Practice 4th Edition	Jan-18
Malaysian-Guideline-for-Application-of-CTIL-and-CTX-8th-Ed-Final (Effective on 30 April 2024)	Mac-2024
Malaysian-Guideline-for-Application-of-CTIL-and-CTX-7.1-Edition	Sept-2021
Guidelines for Good Clinical Practice (GCP) Inspection, Edition 2.1	Dec-2020
Malaysian Guideline for Phase I Unit Inspection and Accreditation Programme	Jun-18
Malaysia Guideline for BE Inspection, First Edition	Oct-14
Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First Edition	Jun-16
Malaysian Guideline for Safety Reporting of Investigational Products	Oct-14

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weixin updated an article

Guidelines for Clinical Trial

20th Mar, 2024
Application Form - Clinical Trial

Document Name	Updated
Malaysian Guidelines for Good Clinical Practice 4th Edition	Jan-18
Malaysian-Guideline-for-Application-of-CTIL-and-CTX-8th-Ed-Final (Effective on 30 April 2024)	Mac-2024
Guidelines for Good Clinical Practice (GCP) Inspection, Edition 2.1	Dec-2020
Malaysian Guideline for Phase I Unit Inspection and Accreditation Programme	Jun-18
Malaysia Guideline for BE Inspection, First Edition	Oct-14
Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First Edition	Jun-16

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weixin updated an article

Guidelines for Clinical Trial

20th Mar, 2024
Application Form - Clinical Trial

Document Name	Updated
Malaysian-Guideline-for-Application-of-CTIL-and-CTX-8th-Ed-Final (Effective on 30 April 2024)	Mac-2024
Malaysian-Guideline-for-Application-of-CTIL-and-CTX-7.1-Edition	Sept-2021
Guidelines for Good Clinical Practice (GCP) Inspection, Edition 2.1	Dec-2020
Malaysian Guideline for Phase I Unit Inspection and Accreditation Programme	Jun-18
Malaysian Guidelines for Good Clinical Practice 4th Edition	Jan-18
Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First Edition	Jun-16
Malaysia Guideline for BE Inspection, First Edition	Oct-14
Malaysian Guideline for Safety Reporting of Investigational Products, First Edition	Oct-14

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weixin updated an article

Application Forms for Clinical Trial

26th Aug, 2020
Application Form - Clinical Trial

Document Name	PDF	MS Word	MS Excel	Current edition	Effective starting 1st May 2024 (PDF version only)
NPRA/427/01-2 Borang Permohonan Lesen Import Percubaan Klinikal (CTIL)			-	Sept-22
NPRA/427/02-2 Borang Permohonan Kebenaran Mengilang Produk-produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX)			-	Sept-22
NPRA/427/03-2 Borang Permohonan Variasi CTIL CTX			-	Sept-22
NPRA/427/08 Borang Penyerahan Yuran Pemprosesan Lesen Import Percubaan Klinikal	-	-	-	-
Standardised file organisation folder for CTIL/CTX application	-	-	-	-
NPRA/433/07-1 CTILCTX Protocol Deviation Template	-	-		Jul-22	-
NPRA/433/06-1 Permohonan Pemeriksaan Untuk Program Akreditasi Bagi Unit Fasa Satu	-		-	Jul-22	-

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weixin updated an article

Application Forms for Clinical Trial

26th Aug, 2020
Application Form - Clinical Trial

Document Name	PDF	MS Word	MS Excel	Current edition	Effective starting 1st May 2024 (PDF version only)
NPRA/433/06-1 Permohonan Pemeriksaan Untuk Program Akreditasi Bagi Unit Fasa Satu	-		-	Jul-22	-
NPRA/427/01-2 Borang Permohonan Lesen Import Percubaan Klinikal (CTIL)			-	Sept-22
NPRA/427/02-2 Borang Permohonan Kebenaran Mengilang Produk-produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX)			-	Sept-22
NPRA/427/03-2 Borang Permohonan Variasi CTIL CTX			-	Sept-22
NPRA/433/07-1 CTILCTX Protocol Deviation Template	-	-		Jul-22	-
NPRA/427/08 Borang Penyerahan Yuran Pemprosesan Lesen Import Percubaan Klinikal	-	-	-	-

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871024565158 updated an article

4 days ago

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Kenyataan Media 22 April 2024- Makluman Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual
23rd Apr, 2024

Press Release 2024
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weixin updated an article

Application Forms for Clinical Trial

26th Aug, 2020
Application Form - Clinical Trial

Document Name	PDF	MS Word	MS Excel	Current edition	Effective starting 1st May 2024 (PDF version only)
NPRA/433/06-1 Permohonan Pemeriksaan Untuk Program Akreditasi Bagi Unit Fasa Satu	-		-	Jul-22	-
NPRA/427/01 Borang Permohonan Lesen Import Percubaan Klinikal (CTIL)			-	Sept-22
NPRA/427/02 Borang Permohonan Kebenaran Mengilang Produk-produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX)			-	Sept-22
NPRA/427/03 Borang Permohonan Variasi CTIL CTX			-	Sept-22
NPRA/433/07-1 CTILCTX Protocol Deviation Template	-	-		Jul-22	-
NPRA/427/08 Borang Penyerahan Yuran Pemprosesan Lesen Import Percubaan Klinikal	-	-	-	-

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