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 …

read more...

NPRA Malaysia Issues Updated Guidance Document on Foreign GMP Inspection

National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued an updated guidance document on foreign GMP inspection in August 2021.  The main update is …

read more...

NPRA Malaysia Issues Updated Guidelines for Pharmacovigilance

National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued two updated guidelines for pharmacovigilance in August 2021.   The updated guidelines are:  “Malaysian Guidelines on Good …

read more...

Singapore HSA and Malaysia NPRA Launch the HSA-NPRA Generic Medicines Work Sharing Initiative

The Health Sciences Authority (HSA) Singapore and the National Pharmaceutical Regulatory Agency (NPRA) Malaysia have launched the HSA-NPRA Generic Medicines Work …

read more...

NPRA Malaysia Issues Updated Guidance Document on Conditional Registration of Pharmaceutical Products During Disaster

National Pharmaceutical Regulatory Agency (NPRA) Malaysia issued an updated guidance document on the requirements of Conditional Registration of Pharmaceutical Products during Disaster, in July 2021.  The main …

read more...

Malaysia MDA Issues Guidelines for Application for Medical Device Advertisement Approval – Requirements  

This guideline specifies the requirements for advertisement of medical devices that require approval and no approval required.  The following materials …

read more...

Malaysia NPRA Strengthens Regulatory Control of Medicinal Gases Classified as Drugs

Malaysia NPRA issues Directive 8 of 2021 on Strengthening of the Implementation of Products Regulatory Control – Medical Gas Products …

read more...

Malaysia NPRA Issues Directive on Registration and Enforcement of Cell and Gene Therapy Products(CGTPs) in Stages

On 14 Dec 2020, Malaysia NPRA issues Directive 19 of 2020 on Registration And Enforcement Of Cell And Gene Therapy Products(CGTPS …

read more...

Malaysia MDA Launches New Version of Search System MEDICAL DEVICE AUTHORITY REGISTER for Registered Medical Devices and Licensed Establishments

On 4th November 2020, the Medical Device Authority of Malaysia issued an announcement to announce that the old PBPP Search …

read more...

More News