Late last year, a significant law was passed by the United States (US) called as “FDA Modernization Act 2.0”. This act essentially allows pharmaceutical companies to apply to US FDA (Food and Drug Administration) to employ alternative non clinical testing instead of animal testing which is the defining standard for a determine its safety, efficacy & toxicity in animals prior to studying it in humans.

For a regulatory approval, it is a mandatory requirement for pharmaceutical companies to provide the animal nonclinical testing data as part of its development process to the regulatory authority for New Chemical Entities (NCE) and Biologics/Biosimilars products. With this law, alternative studies not involving animals can be used (eg cell-based assays, microphysiological systems, bioprinted or computer models) to support the development process of the product. It is important to note that this law is isolated to be used in the US only, but it sets a precedence to other stringent regulatory authorities.

In Malaysia, the submission for a Non Clinical Animal testing is mandatory for NCE and Biologics/Biosimilar product registration. As Malaysia is a member country of OECD Principles of Good Laboratory Practice, the Pivotal Non Clinical Animal data submitted to Malaysia for registration has to be conducted in a facility that abides by the OECD Mutual Acceptance of Data (MAD) Good Laboratory Practice (GLP) monitoring program.

Our consultants have the experience to identify and apply this crucial requirement of NPRA for registration of NCE or Biologic/Biosimilar to our clients to ensure a quality submission dossier to the authority. Contact us for more information !

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