E-Library - Information At Your Fingertips: Printer Friendly 33 of 48 http://elibrary.judiciary.gov.ph/thebookshelf/showdocsfriendly/1/63027 applicant and the public. 2. Review and evaluation of extraneous evidence, e.g., scientific journals, meta-analyses, etc. Step 8. Assess and review the documentary requirements submitted by the applicant. Technical reviewers considered scientific evidence such as meta-analyses, systemic reviews, national and clinical practice guidelines and recommendations of international medical organizations submitted by the companies, organizations and individuals to be part of the review.[20] In a certification proceeding for contraceptives, contraceptives must undergo both the scientific testing necessary for all drugs to test for its safety and efficacy. In addition, contraceptives must likewise be tested for non-abortifacience. Best evidence of non-abortifacience include "meta-analyses, systematic reviews, national clinical practice guidelines where available, and recommendations of international medical organizations."[21] In case of conflict, "more recent, better-designed, and larger studies shall be preferred."[22] The Food and Drug Administration is also authorized to constitute "an independent evidence review group (ERG) composed of leading experts in the fields of pharmacodynamics, medical research, evidencebased medicine, and other relevant fields."[23] Re-certification proceedings, on the other hand, involve a preliminary review of the physiology of the female reproductive system and the classification, regulatory status, and mechanism of hormonal contraceptives in other countries, as well as a two-part evaluation process.[24] The first part is a review of the chemistry, manufacture, and control of the product while the second part evaluates all the scientific data submitted.[25] The present controversy revolves around whether the Food and Drug Administration's authority to determine whether a contraceptive is non-abortifacient is quasi-judicial in nature, and therefore must adhere to the due process standards required of administrative proceedings. Considering the Food and Drug Administration's heavy reliance on scientific data and the highly technical nature of the certification and non certification process, the proceeding is not quasi-judicial in nature. II An administrative agency performs a quasi-judicial function when it has "the power to hear and determine questions of fact to which the legislative policy is to apply and to decide in accordance with the standards laid down by the law itself in enforcing and administering the same law."[26] Its quasi-judicial functions require the agency to "investigate facts or ascertain the existence of facts, hold hearings, weigh evidence, and draw conclusions from them as basis for their official action and exercise of discretion in a judicial nature."[27] Otherwise stated, an agency performs 4/21/2020, 9:19 AM