Malaysia: NPRA directs use of the July 2026 DRGD revision
NPRA posted on 16 July 2026 a directive dated 10 July 2026 requiring use of the Drug Registration Guidance Document, Third Edition, 12th Revision July 2026.
On 16 July 2026 the National Pharmaceutical Regulatory Agency posted a directive on use of the Drug Registration Guidance Document (DRGD), Third Edition, 12th Revision July 2026. The directive itself is dated 10 July 2026 and is published as Direktif Bil. 18 Tahun 2026.
The DRGD is NPRA’s main guidance for drug registration in Malaysia. Sponsors preparing new applications or variations should use the July 2026 revision rather than an earlier edition.
Source: NPRA, Direktif untuk penggunaan DRGD Third Edition, 12th Revision July 2026.
Related markets: Malaysia
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