Jul 24, 2023 BY No Comments

Evolving Landscape of Non-Clinical Study in Regulatory Approval Process

Late last year, a significant law was passed by the United States (US) called as “FDA Modernization Act...

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May 26, 2023 BY No Comments

Complex Generic Product Registration

The boundaries of a generic product registration are expanding at a greater rate yearly. It has evolved far...

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Mar 20, 2023 BY Comments Off on Biologics & Biosimilars, are they an equivalent to the originator product ?

Biologics & Biosimilars, are they an equivalent to the originator product ?

This is a question still lingering in the pharmaceutical industry for some time. Biologics/biosimilars are not like the...

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May 30, 2018 BY No Comments

Registration Process Scenario in Malaysia

Registration of pharmaceutical products in Malaysia is not as straight forward process as compared to other ASEAN countries....

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May 30, 2018 BY No Comments

Classification of Products

In Malaysia, there are several classes of pharmaceutical registration regulated by NPRA. These would include New Chemical Entity,...

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May 30, 2018 BY No Comments

Registration System by NPRA

For registration of any pharmaceutical products with NPRA, the entire process is done online with soft copies of...

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