Policy and purpose
- Administrative Order No. 86, s. 2000 is issued to facilitate the objective evaluation of New and Registered Drugs.
- The Order is issued to provide adequate information to the consuming public.
- The Order is issued to ensure the safety and efficacy of drugs to protect the health of the people.
Scope: who must comply
- All drug manufacturers must employ a Medical Director (or any equivalent title) under Administrative Order No. 86, s. 2000.
- All drug traders must employ a Medical Director (or any equivalent title) under Administrative Order No. 86, s. 2000.
- All drug distributors/importers must employ a Medical Director (or any equivalent title) under Administrative Order No. 86, s. 2000.
- The Medical Director requirement covers establishments handling and dealing in new and registered drugs.
Staffing requirement and appointment mode
- Drug Establishments required to have a Medical Director must include the Medical Director as part of their staffing complement.
- The Medical Director may work full-time, part-time, or on a consultancy basis.
- Drug Establishments must have the Medical Director registered with the Bureau of Food and Drugs (BFAD).
- BFAD registration is done by the management of the drug establishments, provided the Medical Director is a certified member of the Philippine College of Pharmaceutical Medicine.
Required qualifications of Medical Director
- A Medical Director must be a Doctor of Medicine duly registered with the Professional Regulation Commission.
- A Medical Director must complete a residency training program in a reputable medical facility or must be a faculty member in a recognized medical school, preferably in Pharmacology, for at least three (3) years.
- A Medical Director must have any equivalent training in the field of Pharmacoloy or Clinical Pharmacology for at least three (3) years, consistent with the qualification requirement.
- A Medical Director must have satisfactorily earned the Diploma in Pharmaceutical Medicine or have passed the examinations given by the Specialty Board of Pharmaceutical Medicines within three (3) years of being employed by any pharmaceutical company in the Philippines.
Duties, responsibilities, and operational role
- The Medical Director must clear communications with BFAD regarding New Drugs and Investigational New Drugs.
- Communications must include follow-up of application for registration of New Drugs and Investigational New Drugs and must address matters arising from clinical investigation.
- Clearance of communications must be coursed through the Medical Director, with the assistance of the establishment’s registered pharmacist.
- The Medical Director must approve package inserts, labels, brochures, and other labeling and promotion materials.
- Approval of labeling and promotional materials must be undertaken with the assistance of the registered pharmacist prior to submission to BFAD.
- The Medical Director must serve as a liaison officer with BFAD, Pharmaceutical and Health Care Association of the Philippines, and other equivalent pharmaceutical industry associations, and with the Philippine Medical Association and its specialty and affiliate societies, and with other government agencies and related organizations.
- The Medical Director must implement clinical trial activities, including:
- Preparing or adopting clinical trial protocols for pre-and post-marketing phases of drug development;
- Coordinating the conduct of clinical trials with the clinical investigator(s) and clinical research associates;
- Submitting a complete report on the outcome of a clinical trial to BFAD.
- The Medical Director must provide assistance in the training program of medical representatives, supervisors, pharmacists, and other personnel of the drug establishment.
Supersession and repealing effect
- Administrative Order No. 86, s. 2000 supersedes Administrative Order No. 34, series 1979.
- Administrative Order No. 86, s. 2000 supersedes all other orders inconsistent with this Order.