[Belal]

Can anyone share the most stringent 10 pharmaceutical regulatory authorities?

[Pharma Digests]

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 3 months, 1 week ago by .

[aid]

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

[FRD]

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

[Pharma Digests]

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.

[Author]

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