QuestionsQuestions (ADMINISTRATIVE ORDER NO. 86, S. 2000)
It sets guidelines to facilitate objective evaluation of new and registered drugs, provide adequate information to the consuming public, and ensure the safety and efficacy of drugs to protect public health.
All drug establishments that handle and deal in new and registered drugs, including drug manufacturers, drug traders, and drug distributors/importers under AO 56, s. 1989.
No. The Medical Director may work full-time, part-time, or on a consultancy basis.
The management must register the Medical Director with the BFAD, provided that the Medical Director is a certified member of the Philippine College of Pharmaceutical Medicine.
He/She must be a Doctor of Medicine registered with the PRC; must have finished a residency training program in a reputable facility or be a faculty member in a recognized medical school (preferably in pharmacology) for at least three (3) years or equivalent training; and must have earned the Diploma in Pharmaceutical Medicine or passed the Specialty Board of Pharmaceutical Medicines exams within three (3) years of being employed in the Philippines.
The Medical Director must satisfactorily earn the Diploma or pass the Specialty Board exams within three (3) years of being employed by any pharmaceutical company in the Philippines.
All communications regarding New Drugs and Investigational New Drugs must be cleared through the Medical Director, with assistance of the registered pharmacist of the establishment.
Clearance of all communications with BFAD regarding New Drugs and Investigational New Drugs, including follow-up of application for registration and matters arising from clinical investigation.
The Medical Director must approve all package inserts, labels, brochures, and other labeling and promotion materials.
These approvals must be undertaken with the assistance of the registered pharmacist of the establishment prior to submission to BFAD.
Serve as liaison officer with BFAD; the Pharmaceutical and Health Care Association of the Philippines and other equivalent industry associations; the Philippine Medical Association and its specialty and affiliate societies; and other government agencies and related organizations.
Prepare or adopt clinical trial protocols for pre- and post-marketing phases; coordinate the conduct of clinical trials with investigators and clinical research associates; and submit a complete report on the outcome of a clinical trial to BFAD.
Assist in the training program of medical representatives, supervisors, pharmacists, and other personnel of the drug establishment.
It supersedes Administrative Order No. 34, series 1979, and all other orders inconsistent with it.
Upon publication in two (2) newspapers of general circulation, and it states it shall take effect immediately upon such publication.
Because the guidelines aim to protect public health by ensuring proper evaluation and supervision of new/registered drugs, proper information to consumers, and compliance-related responsibilities that support drug safety and efficacy.