Reference Regulatory Authorities for Registration of Products in Drug Regulatory Authority of Pakistan (DRAP)

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Arooj Abid

Reference Regulatory Authorities for Registration in Drug Regulatory Authority of Pakistan.

Gesundheit & Medizin

REFERENCE
REGULATORY AUTHORITIES
ACCORDING TO DRAP
AROOJ ABID
PHARM.D, CRCP, R.PH
1

DRAP POLICY GUIDELINES
REGARDING REFERENCE
REGULATORY AUTHORITIES
FOR REGISTRATION OF
DRUGS
2

The molecules/ formulations should
be
(in same dosage form and strength)
alongwith clinical trials.
3

Registered by drug regulatory
agencies of
• USFDA
• Health Canada
• EMA
• TGAAustralia
• PMDA Japan
• United Kingdom
• Germany
• France
4

• Switzerland
• Netherlands,
• Austria
• Denmark
• Sweden
• Norway
• or drugs registered in at least three
European Union countries
5

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Reference Regulatory Authorities for Registration of Products in Drug Regulatory Authority of Pakistan (DRAP)

1. REFERENCE REGULATORY AUTHORITIES ACCORDING TO DRAP AROOJ ABID PHARM.D, CRCP, R.PH 1

2. DRAP POLICY GUIDELINES REGARDING REFERENCE REGULATORY AUTHORITIES FOR REGISTRATION OF DRUGS 2

3. The molecules/ formulations should be (in same dosage form and strength) alongwith clinical trials. 3

4. Registered by drug regulatory agencies of • USFDA • Health Canada • EMA • TGAAustralia • PMDA Japan • United Kingdom • Germany • France 4

5. • Switzerland • Netherlands, • Austria • Denmark • Sweden • Norway • or drugs registered in at least three European Union countries 5