E-Library - Information At Your Fingertips: Printer Friendly 31 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 Republic Act No. 10354, however, explicitly outlines the steps the Food and Drug Administration must undertake in order to identify if a particular contraceptive or intrauterine device is non-abortifacient: Section 7.04 FDA Certification of Family Planning Supplies. - The FDA must certify that a family planning drug or device is not an abortifacient in dosages of its approved indication (for drugs) or intended use (for devices) prior to its inclusion in the EDL. The FDA shall observe the following guidelines in the determination of whether or not a drug or device is an abortifacient: a) As defined in Section 3.01 (a) of these Rules, a drug or device is deemed to be an abortifacient if it is proven to primarily induce abortion or the destruction of a fetus inside the mother's womb or the prevention of the fertilized ovum to reach and be implanted in the mother's womb; b) The following mechanisms do not constitute abortion: the prevention of ovulation; the direct action on sperm cells prior to fertilization; the thickening of cervical mucus; and any mechanism acting exclusively prior to the fertilization of the egg by the sperm; c) In making its determination, the FDA shall use the best evidence available, including but not limited to: meta-analyses, systematic reviews, national clinical practice guidelines where available, and recommendations of international medical organizations; d) In the presence of conflicting evidence, the more recent, betterdesigned, and larger studies shall be preferred, and the conclusions found therein shall be used to determine whether or not a drug or device is an abortifacient; and e) Should the FDA require additional expertise in making its determination, an independent evidence review group (ERG) composed of leading experts in the fields of pharmacodynamics, medical research, evidence-based medicine, and other relevant fields may be convened to review the available evidence. The FDA shall then issue its certification based on the recommendations of the ERG.[18] Upon the effectivity of the Implementing Rules and Regulations of Republic Act No. 10354, all "health care drugs, supplies, and products" with prior Certificates of Product Registration must undergo a re-certification process with the Food and Drug Administration to prove that they are safe and non-abortifacient.[19] In order to aid the re-certification process of Marketing Authorization Holders of contraceptive drugs, the Center for Drug Regulation and Research formulated the steps to be undertaken: Step 1. Identify contraceptive products in the database. Create another 4/21/2020, 9:19 AM