Malaysia NPRA Updates Expansion Scope of The Requirements For The Bioequivalence (BE) Study Centres Accreditation And Exemption Of The BE Study Inspection Assessment

In line with current developments, the scope of BE study center inspection requirement has been expanded.

The Immediate Implementation scope is as follows:

1. BE studies conducted at BE study centers during the validity period of the listing in the ASEAN BE Center List involve:

• Generic products and generic products where the innovator product has never been registered in Malaysia that are immediate-release, oral, solid dosage forms, with systemic actions that contain scheduled poison active ingredients.

2. Products eligible for evaluation through the FRP procedure:

• All generic products in the form of oral tablets/capsules that are immediate-release, modified release, effervescent, dispersible, orodispersible, sublingual, buccal and chewable that contain scheduled poison active ingredients.
• Generic products where the innovator product has never been registered in Malaysia.

For more information, kindly refer to the link:

https://npra.gov.my/easyarticles/images/users/1153/DCA/Direktif/Bil.3-Tahun-2025_Direktif-Perluasan-Skop-Keperluan-Akreditasi-Pusat-Kajian-BE–Pengecualian-Penilaian-Pemeriksaan-Kajian-BE.pdf

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