NPRA Malaysia Publishes Guide on Voluntary Good Pharmacovigilance Practices (GVP) Inspection

The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has published the first edition of the “Malaysian Guidance Document on Voluntary Good …

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NPRA Malaysia Publishes Updates on Guidance and Requirements on Conditional Registration of Pharmaceutical Products During Disaster

National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued the third revised version of the guidance and requirements on conditional registration …

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NPRA Malaysia Publishes Frequently Asked Questions on Medicinal Gases

National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued a set of frequently asked questions (FAQs) on medicinal gases in February …

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MDA Malaysia Publishes Guidance Document on Refurbished Medical Devices

The Malaysian Medical Device Authority (MDA) has published a guidance document on the requirements for refurbished medical devices in January …

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NPRA Malaysia Issues Latest Drug Registration Guidance Document

National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued the latest updated version of the Drug Registration Guidance Document (DRGD) in …

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MDA Malaysia Publishes Updated Circular on Conformity Assessment Procedures for Medical Device Approved by Recognised Countries 

The Malaysian Medical Device Authority (MDA) has published an updated circular regarding the conformity assessment procedures for medical devices approved by recognised countries, …

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MDA Malaysia Publishes Updates on Establishments Acting as Authorized Representatives and Establishments Carrying Out Different Activities

The Malaysian Medical Device Authority (MDA) has revoked Circular Letter No. 1/2014 that contains two components, namely establishments acting as authorized representatives (AR) and establishments carrying out …

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NPRA Malaysia and MDA Malaysia Issues Updated Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products

National Pharmaceutical Regulatory Agency (NPRA) Malaysia and Medical Device Authority (MDA) Malaysia have issued an updated guideline, which is the …

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NPRA Malaysia Issues Updated Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption

National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued an updated guideline on clinical trial import licence (CTIL) and clinical trial exemption (CTX) in September 2021.   The updated guideline …

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