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Faculty of Health Sciences
First Semester M. Pharmacy Degree Examination
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Time: Three Hours Max. Marks: 75 Marks
International Regulatory Aspects of FNPCMB
Q.P. CODE: 5123
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
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LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- Write in detail about history and evolution of FFDCA of USA.
- Discuss about organization and structure of EMA.
- Elaborate in detail about drug regulatory approval process in Japan.
- Write in detail about drug regulatory approval process in ASEAN region.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Write briefly about DMF system in US.
- Write about national and mutual recognition procedures in EU.
- Write a note on types of registration applications in China.
- Approval process for IND in USA
- Write a note on Eudralex directives for human medicines.
- Write a note on drug approval in a south Asian country.
- Write briefly about compliance of European pharmacopoeia.
- Short note on post marketing surveillance in Japan.
- Regulatory requirements for registration of drugs in Brazil
- Write a note on marketing authorization transfers (MA).
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