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Registration and Regulatory Requirements of Generic Drugs Marketing Authorization in “BRICS” Countries
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The comparative study of generic drug registration in BRICS, was to find out the differences among the guidelines. “BRICS” mainly refers to Brazil, Russia, India, china and South Africa. The regulatory requirements of each country is different from each other, “BRICS” has the fastest growing and largest emerging markets which shows the positive growth in the pharmaceutical companies. The medical regulatory system in the BRICS countries is increasing in the medical profession to safeguard and promote the medicine. The BRICS countries together is consider as important emerging economics, which has 40% of world population. To develop the universal health coverage, The BRICS countries of national institution agreed to join hands with (WHO), world health organization.
Keywords
Regulatory Requirements, Registration Process, Brazil, Russia, India, China and South Africa (BRICS), Generic Products.
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- Marketing Authorization Available from: http://en.wikipedia.org/ wiki/Marketing authorization
- Brazilian National Health Vigilance Sanitaria Available from:
- http://www.ghtf.org/meetings/conferences/9thconference/presentations/latinamerican/waynebrodbeskow.pdf
- National Health Surveillance Agency: http://www.anvisa.gov.br/hotsite/genericos/legis/leis/6360_e.htm
- National Health Surveillance Agency: Resolution no nº 3.675 http://www.anvisa.gov.br/eng/legis/resol/136_03_ redc_e.htm
- National Health Surveillance Agency: http://www.puntofocal.gov.ar/notificotros_miembros/bra226_t.pdf
- National Health Surveillance Agency Legislation Resolution- RE nº 478 http://www.silvademoraes.com.br/site_ingles/jurisprudence/food_drugs_itens.html Drug Registration and Labelling in Brazil: http://www.princeton.edu/~ota/ disk1/1993/9321/932111.PDF
- Russian federation [Online]: Available from: www.roszdravnadzor.ru.
- Registration of Pharmaceutical Products in Russia: http://pharmareg.ru/upload/ReportAChorichFrankfurt.pdf
- Drug regulatory requirements in Russia [Online]: www.pharmabiz.com/article/detnews.asp
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