The World Health Organisation (WHO) defines reliance as the act whereby the regulatory authority in one jurisdiction takes into account and gives significant weight to assessments performed by another regulatory authority or trusted institution, or to any other authoritative information, in reaching its own decision. The relying authority remains independent, responsible and accountable for the decisions taken, even when it relies on the decisions, assessments and information of others.

NPRA is committed to ensuring the quality, safety, and efficacy of medicinal products while facilitating timely public access through rigorous regulatory oversight. By practicing reliance, NPRA enhances regulatory efficiency, optimises resources, and accelerates access of essential medicines and vaccines to the public.

The reliance mechanism is applied by leveraging the work performed by other regulatory bodies on the same products intended for the local market. This mechanism is initiated to reduce duplication of effort and enables NPRA to emphasise the risk-based approach in regulatory activities. Reliance procedures provide a more efficient review process and ultimately early access to pharmaceutical products in the market.

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NPRA relies on the National Regulatory Authorities (NRAs) approved by the Drug Control Authority as listed below:

1. European Medicines Agency (EMA)
2. Health Canada
3. Health Sciences Authority (HSA) Singapore
4. Medicine and Healthcare products Regulatory Agency United Kingdom (UKMHRA)
5. Pharmaceuticals and Medical Devices Agency (PMDA) Japan
6. Swissmedic
7. Therapeutic Goods Administration (TGA) Australia
8. United States Food and Drug Authority (USFDA)

Malaysia adheres to the OECD Mutual Acceptance of Data (MAD) for Good Laboratory Practice (GLP). Therefore, NPRA accepts pivotal non-clinical safety study data (e.g., toxicology, reproductive toxicity, immunotoxicity) from OECD-MAD GLP-compliant laboratories in member and adherent countries without requiring duplicate testing. This also extends to recognizing GLP inspections and their outcomes from these countries.

NPRA is also a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). This enables NPRA to accept GMP certificates and inspection reports from other PIC/S member regulatory authorities (as listed on the PIC/S website) as well as National Regulatory Authorities with a cooperation agreement, such as an MRA, with PIC/S.

As an ASEAN member, NPRA also accepts GMP certificates and inspection reports from ASEAN Listed Inspection Services (ASEAN LIS) under the ASEAN Sectoral MRA for GMP Inspection. In addition, NPRA also accepts bioequivalence studies conducted at bioequivalence centres listed under the ASEAN MRA for Bioequivalence Study Reports of Generic Medicinal Products.