E-Library - Information At Your Fingertips: Printer Friendly 30 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 Under Republic Act No. 10354,[14] the Food and Drug Administration is likewise given the authority to determine whether a drug or device is considered an abortifacient.[15] In order for a contraceptive to be considered medically safe and non-abortifacient, it must have been registered and approved by the Food and Drug Administration in accordance with its "scientific and evidence-based medical research standards."[16] In addition to the regular registration and certification process required for established drugs and new drugs, Market Authorization Holders (MAHs) must also undergo a process to determine if their contraceptive is safe and nonabortifacient. Before the effectivity of Republic Act No. 10354, the Center for Drug Regulation and Research followed this procedure for the registration of contraceptives: Step 1. The FDA receives applications of MAH [Market Authorization Holder] through its Public Assistance, Information and Receiving (PAIR) Unit. Step 2. The FDA evaluates whether the MAH submitted complete documents for review. Step 3. The FDA schedules and decks the application for registration to the evaluator. Step 4. The Junior Evaluator of the CDRR Registration Section, Human Drugs-Chemistry Manufacturing and Controls Unit evaluates the contraceptive product for quality. The Junior Evaluator of the CDRR Registration Section, Human Drugs-Clinical Research Unit and FDA medical consultants evaluate the contraceptive product for safety and efficacy, as applicable. Step 5. The Senior Evaluator of the CDRR Registration Section, Human Drugs-Chemistry Manufacturing and Controls Unit and Senior Evaluator of the Clinical Research Unit checks [sic] the findings of the Junior Evaluators. Step 6. The FDA Consultants and the Evaluators meet for final assessment and recommendation. Step 7. Issuance of CPR/Notice of Deficiencies/Letter of Denial. Step 8. The FDA uploads a copy of the CPR at the FDA Inventory System. The FDA also uploads the product details such as registration number, generic name, brand name, dosage strength and form, the NIAH, and CPR Validity at the FDA website. Step 9. Release of the CPR or letter through PAIR Unit.[17] 4/21/2020, 9:19 AM