Reply To: Most Stringent Regulatory Authorities

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Pharma Digests
Pharma Expert

    Stringent Regulatory Authority
    The World Health organisation (WHO) classifies a stringent regulatory authority (SRA) as a national drug regulatory authority that applies stringent quality standards, safety, and usefulness in its regulatory assessment of medicines and vaccines for marketing approval. The approval by the SRA is an indication of the product’s high degree of efficacy and safety.

    Less Stringent Regulatory Aauthority
    A national drug regulatory authority that applies flexibiity in its regulatory assessment of medicines and vaccines for marketing approval in respect to quality standards, safety, and usefulness.