This case has been cited 1 times or more.
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2014-03-05 |
PERLAS-BERNABE, J. |
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| The FDA[3] was created pursuant to Republic Act No. (RA) 3720,[4] otherwise known as the "Food, Drug, and Cosmetic Act," primarily in order "to establish safety or efficacy standards and quality measures for foods, drugs and devices, and cosmetic product[s]."[5] On March 15, 1989, the Department of Health (DOH), thru then-Secretary Alfredo R.A. Bengzon, issued Administrative Order No. (AO) 67, s. 1989, entitled "Revised Rules and Regulations on Registration of Pharmaceutical Products." Among others, it required drug manufacturers to register certain drug and medicine products with the FDA before they may release the same to the market for sale. In this relation, a satisfactory bioavailability[6]/bioequivalence[7] (BA/BE) test is needed for a manufacturer to secure a CPR for these products. However, the implementation of the BA/BE testing requirement was put on hold because there was no local facility capable of conducting the same. The issuance of Circular No. 1, s. 1997[8] resumed the FDA's implementation of the BA/BE testing requirement with the establishment of BA/BE testing facilities in the country. Thereafter, the FDA issued Circular No. 8, s. 1997[9] which provided additional implementation details concerning the BA/BE testing requirement on drug products.[10] | |||||