ADMINISTRATIVE ORDER No. 2014-0040

SUBJECT : REVISED GUIDELINE ON THE NEED / ROLE OF A MEDICAL DIRECTOR IN THE PHARMACEUTICAL INDUSTRY


I. Rationale

Administrative Order 34 s 1979 was issued by the Bureau of Food and Drugs (BFAD), now the Food and Drug Administration (FDA), to require pharmaceutical laboratories and drug departments handling and dealing with new drugs to have a Medical Director. The primary responsibility of the Medical Director is to review clinical protocols and supervise the conduct of clinical trial and to review product labels. This issuance was superseded by Administrative Order 86 s 200 to clearly set the FDA requirements for drug establishments to have a Medical Director, his/her qualifications, roles and responsibilities among others.

The Food and Drug Administration has undergone a series of reforms to improve the efficiency of its operations ad improved compliance of the industry to policies, guidelines, rules and regulation for the protection for the protection of public health and welfare, with the passage on several Republic Acts, notably RA 9502, otherwise known as the Universally Accessible Cheaper and Quality Medicines Act of 2008; RA 9711 or the FDA Act of 2009, Administrative Order 009 s 2011 o the National Policy and Program on Pharmacovigilance, and other pertinent FDA Circulars on Post Market Surveillance, Clinical Trials, Adaptation of the Mexico City and Kuala Lumpur Principles, among other.


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