Your Guide to Malaysia
Here below we help you dive deep into the regulatory requirements of Malaysia and answer some of the basic questions.
Still confused with the complete process? - Genedrift assists you with all regulatory requirements as mentioned.
Guide to Drugs
The registration - from start to end !
The registration process at NPRA Malaysia is well defined and mostly electronic. eSubmissions is the primary mode however, hard copies are also required to be submitted. Registration is mandatory for all medicinal products. Site audits are insisted upon unless the site has EU / PICs / regulated market accreditation.
The process requires for online submission of the Dossier with NPRA through their online portal - Quest. A detailed technical sheet along with application form is to be filled and submitted. Depending on the product documentation, a site audit is scheduled for the manufacturing site and also the CRO. However, timelines for each activity are defined, but because of various reasons, these are rarely met.
The process can only be done through local Malaysian company which have a legal registration, in the trade of pharmaceuticals and Quest account access. Samples are not required for purpose of analysis, however, the NPRA may ask us to submit representative samples.
The complete process usually takes between 30 to 42 months.
Depending on requirements, we can file applications through your Quest account or yours !!
Mutual ASEAN Recognition is followed for GMP Clearances. In absence of any accreditation, site audits are triggered upon Dossier submission
Document - Checklist
The NPRA follows Full and Abridged evaluation through ACTD, with various changes according to the Poison / Non Poison Category. The checklist varies for all categories.
As a general reference, we have enclosed here a checklist, fresh filing. FDA accepts only stability studies conducted under Zone IV B conditions.
Need our assistance ! We, at Genedrift can handle this for you.
Click here to download the checklist.
Guide to Drugs
The registration - from start to end !
The registration process at NPRA Malaysia is well defined and mostly electronic. eSubmissions is the primary mode however, hard copies are also required to be submitted. Registration is mandatory for all medicinal products. Site audits are insisted upon unless the site has EU / PICs / regulated market accreditation.
The process requires for online submission of the Dossier with NPRA through their online portal - Quest. A detailed technical sheet along with application form is to be filled and submitted. Depending on the product documentation, a site audit is scheduled for the manufacturing site and also the CRO. However, timelines for each activity are defined, but because of various reasons, these are rarely met.
The process can only be done through local Malaysian company which have a legal registration, in the trade of pharmaceuticals and Quest account access. Samples are not required for purpose of analysis, however, the NPRA may ask us to submit representative samples.
The complete process usually takes between 30 to 42 months.
Depending on requirements, we can file applications through your Quest account or yours !!
Mutual ASEAN Recognition is followed for GMP Clearances. In absence of any accreditation, site audits are triggered upon Dossier submission
Document - Checklist
The NPRA follows Full and Abridged evaluation through ACTD, with various changes according to the Poison / Non Poison Category. The checklist varies for all categories.
As a general reference, we have enclosed here a checklist, fresh filing. FDA accepts only stability studies conducted under Zone IV B conditions.
Need our assistance ! We, at Genedrift can handle this for you.
Click here to download the checklist.
Guide to Cosmetics
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