Most Stringent Regulatory Authorities

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  • #5468
    Belal
    Participant

      Can anyone share the most stringent 10 pharmaceutical regulatory authorities?

      #5469
      Pharma Digests
      Pharma Expert

        Here is the list of most stringent regulatory authorities:
        1. US FDA
        2. EMA (European Union)
        3. ANVISA (Brazil)
        4. Health Canada
        5. TGA (Australia)
        6. PMDA (Japan)
        7. SAHPRA (South Africa)
        8. NPRA (Malaysia)
        9. NPMA (China)
        10. HSA (Singapore)

        It may slightly vary based on the cGMP practice and clinical study requirements.

        • This reply was modified 2 months ago by .
        #5473
        aid
        Participant

          Following regulatory authorities also highly stringent:
          UK MHRA
          Swissmedic
          SFDA
          Danish Medicines Agency
          Norwegian Medicines Agency

          #6262
          FRD
          Participant

            What is the difference between most stringent and less stringent regulatory authority?

            #6267
            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.

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