Malaysia’s NPRA: Guidance for Bioequivalence Inspection
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Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT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