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ananth ☆ India, 2018-10-31 11:23 (2369 d 06:14 ago) Posting: # 19506 Views: 3,337 |
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Dear All, Can you please suggest, which regulatory guidelines is followed in Morocco for bio-equivalence studies. thanks and regards Ananth Prabhu |
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rajasekharkakarla ☆ India, 2018-11-01 09:05 (2368 d 08:33 ago) @ ananth Posting: # 19511 Views: 2,825 |
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Dear Ananth, The Council of Government, adopted the draft decree n ° 2-17-429 modifying and completing the decree n ° 2-12-198 of the 21 Rajab 1433 (June 12th, 2012) relating to the bioequivalence of the medicines generics. Presented by the Minister of Health (MOH), this draft decree is part of the adherence to the latest recommendations of the World Health Organization (WHO) and new international standards for bioequivalence. This text includes several provisions, including the definition of bioequivalence, bioavailability, reference product and indications, said the minister, adding that it is also necessary to determine the conditions necessary to conduct a bioequivalence study. Regards, Rajasekhar Kakarla |
Ing. Helmut Schütz