Other Guidelines for Generic Medicine

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Guidelines - Generic Medicine

: Posted By Jauze; 05 October 2018; Hits: 2668

User Rating: 3 / 5

2019
- 4.4 : Post-Marketing Activities 2019-03-13
- Drug Registration Guidance Document : Second Edition – September 2016, Revised July 2019 2019-01-17
- Garispanduan Pelaksanaan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) 2019-01-09
2018
- Direktif Mengenai Syarat Pendaftaran Produk Farmaseutikal Dari Luar Negara Berkaitan Keperluan Amalan Perkilangan Baik (APB) 2018-11-13
- Cold Chain Inspection 2018-09-25
- Guidelines for Clinical Trial 2018-08-30
- Product Validation 3.1 - 3.8 : Active Ingredients 2018-08-29
- Product Validation 4.1 - 4.5 : Excipients 2018-08-29
- Product Validation PV5 - PV18 : Other Information 2018-08-29
- Variation Application For Pharmaceutical Products 2018-07-25
- Dokumen Panduan Keperluan Direktif Bilangan 2 Tahun 2014 dan Bilangan 2 Tahun 2015 2018-07-02
- Guidance Document Foreign GMP Inspection July 2018 2018-07-02
- Guideline For The Submission Of Product Samples For Laboratory Testing 2018-06-12
- Licensing (Manufacturer, Importer and Wholesaler) 2018-01-04
- Guideline on Good Distribution Practice (Third Edition, 2018) 2018-01-01
2016
- Malaysian Pharmacovigilance Guidelines 2nd Edition 2016-09-07
2015
- Template/Guide for Product Information (PI) for Generic Products 2015-07-09
2013
- Good Manufacturing Practice/Good Distribution Practice 2013-05-14

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National Pharmaceutical Regulatory Agency (NPRA)

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