Regulatory Blog

Malaysia NPRA: Electronic Labelling (E-Labelling) Guidance For Pharmaceutical Products

Malaysian Guideline for Application of Clinical Trial Import Licence (CTIL) & Clinical Trial Exemption (CTX)

Malaysia NPRA: Guidelines for Registration of Biosimilars in Malaysia

Malaysia NPRA: Guidance on Drug Registration

Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity

Malaysia's Medical Device Authority: Guideline on Medical Face Mask and Respirator

Malaysia NPRA: Guideline on Electronic Labelling (E-LABELLING) for Pharmaceutical Products

Malaysia’s MDA : Guidance on Classification of Rehabilitation, Physiotherapy & Speech Therapy Device

Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System

Malaysia MD Guidance: How to Submit an Application for Registration of a Refurbished Medical Device

Malaysia’s MDA: Med Dev Guidance on Requirement for Labeling & Change Notification of Registered MD

Malaysia’s MDA: HARMONISED CLASSIFICATION OFMEDICAL DEVICES IN ASEAN

MALAYSIAN (NPRA): VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS

Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT

Guidance on Classification of Rehabilitation Medical Devices -Malaysia’s MDA

Malaysia’s MDA- Draft Medical Device Labeling Guidance

Draft Guidleline on Change Notification For Registered Medical Device-Malaysia’s MDA

Voluntary GVP Inspection on Pharma Product Registration Holders- Malaysia’s NPRA

Malaysia Draft Medical Device Guidance on PERSONAL PROTECTIVE EQUIPMENT (PPE) - REQUIREMENTS

Malaysia's Medical Device Authority Guidance on Refurbished Medical Devices.