Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY
Manila

March 15, 1989

ADMINISTRATIVE ORDER
No. 66 s. 1989

SUBJECT: RULES AND REGULATIONS ON THE PROCESS

OF REVIEW AND EVALUATION OF
QUESTIONED DRUG OR DRUG PRODUCTS

SUMMARY: This Order prescribes the procedure of review and evaluation of questioned drug or drug products
with the end in view of banning the same from the market or restricting the conditions of their
(BFAD) registration. The same procedure or process of review and evaluation may also result to a
confirmation of the efficacy, safety or therapeutic value found by BFAD during the initial
registration of the drug product.

Pursuant to Section 3(c) and 26(a) of Republic Act 3720, as amended, the
following rules and regulations are hereby promulgated to govern the banning from the
market of drugs or drug combinations which have been found unsafe, inefficacious or of
doubtful therapeutic value.

SECTION 1 DEFINITION OF TERMS

1.1 “Banning” is an act to prohibit the importation, manufacture, distribution

and sale of a drug determined to be unsafe, inefficacious or of doubtful
therapeutic value as a consequence of which products containing such
drug or drug combination shall not be registered, or if already registered,
they shall be removed from the registry.

1.2 “Drug” means the active ingredient responsible for the pharmacologic or
therapeutic effect of the product.

1.3 “Pharmaceutical or Drug product” is the finished dosage form that

contains the active ingredient(s), generally but not necessarily in
association with inactive ingredients.

SECTION 2 PROCEDURE FOR REVIEW AND EVALUATION

2.1 The process of review and evaluation is initiated when reliable scientific
information indicates that a drug or combination of drugs is unsafe or
inefficacious or of doubtful therapeutic value; or when there is a
complaint by any party with substantial interest. The complaint should be
properly documented and should include the following information:

2.1.1 proper identification of the drug or combination of drugs

2.1.2 description of reason to doubt its safety, efficacy, or therapeutic
value.

2.2 The BFAD review process will involve the following steps:

2.2.1 Notification of affected drug establishment(s) under whose name

the drug product(s) containing the questioned drug or combination
of drugs was registered. The notification shall also include
 information on the process to be followed in reviewing and
evaluating the drug(s) in question.

2.2.2 Notification of other interested parties, if any, that BFAD is

reviewing the status of the drug.

2.2.3 Submission by all interested parties of materials for against the

subject drug.

2.2.3.1 Position papers shall be submitted, in 5 copies, within

30 days after receipt of notice from BFAD.
2.2.3.2 Automatic extension shall not be granted unless partial
submission has been made. The extension shall be
granted only when extension is expected to yield new
material information and only when public safety will
not compromised.

2.2.4 All interested parties shall be furnished copies of the materials

submitted to BFAD in evidence and shall have fifteen (15)
calendar days after their receipt to examine and comment on
these materials.
2.2.5 BFAD reviews all submissions and determines whether a prime
facie case exists against the drug or combination of drugs.

2.2.5.1 If the case is obviously not meritorious BFAD

recommends dismissal of the case to the Secretary of
Health. Should the Secretary of Health that there is
reasonable ground to reverse the BFAD
recommendation, he shall order a public hearing.

2.2.5.2 If the evidence is enough to support a finding that the

drug is unsafe, inefficacious, or of doubtful therapeutic
value, BFAD makes the necessary recommendation to
the Secretary of Health within 30 days from end of
submissions.

2.2.5.3 If the evidence seems meritorious but does not support

a finding, BFAD undertakes a hearing.

2.2.6 Process of Hearing

2.2.6.1 BFAD will publish the order and date of public hearing
which shall not be later than fifteen calendar days from
the date of the publication of such order.

2.2.6.2 The affected drug establishment must justify continued

BFAD registration of the product on the basis of safety,
efficacy, and therapeutic value of active ingredients it
contains. All interested parties may present additional
documentary evidence to clarify and supplement their
position papers within thirty (30) calendar days from the
date of initial hearing. The verified and authentic
evidence and the position papers shall constitute the
direct evidence on the questioned drug.

2.2.6.3 All parties are entitled to cross-examine the witnesses

that may be presented by the interested parties and
affected drug establishments or witnesses who may be
called by BFAD to establish the authenticity, degree of
accuracy and/or propriety of the reports or documents
 submitted in evidence or to testify to any material fact.
For this purpose, BFAD shall require all parties
concerned to submit a list of these witnesses and the
time frame within which they will testify. The list and the
time frame shall be strictly followed. Any witness not in
the list shall not be allowed to testify. Failure to testify
within the approved time frame shall be deemed a
waiver on the part of the interested party.

2.2.7 The BFAD may call upon a panel of experts, if nec0essary to

provide additional information and to evaluate submissions and
evidence. These experts shall advise BFAD on the matter.

2.2.8 The submissions and the evidence presented in the public

hearing shall be evaluated by BFAD on the basis of current
standards for safety, efficacy and therapeutic value as defined in
A.O. No. 67 s. 1989

ANNOTATION: Administration Order No. 67 s. 1989, the subject of which being the “Revised
Rules and Regulation on Registration of Pharmaceutical Products.” It should be
Noted, however, that the rules refer to “current” standards of safety , efficacy and
Therapeutic value used by BFAD such that whatever may be the revised
standards at the time when the questioned drug is under review will be the basis
of the review and evaluation

2.2.9 The BFAD shall make a recommendation to the Secretary of

Health within thirty (30) days from termination of hearing.

2.2.10 The Secretary of Health shall decide the final action to be taken
and shall duly inform the parties concerned of the decision taken.

2.3 This procedure of review and evaluation does not preclude however the
BFAD from submitting a recommendation to immediately ban a drug and
all products containing it in cases where there is a clear finding if serious
or lethal toxicity constituting undue risk to public safety. In which cases,
the BFAD shall submit its finding and recommendation, together with
records of substantial evidence to the Secretary of Health for immediate
action.

Section 3 SEPARABILITY CLAUSE

In case any provision of these rules and regulations is declared contrary to law or
unconstitutional, other provisions which are not affected thereby shall continue to be in
force and in effect.

Section 4 REPEALING CLAUSE

All other administrative orders, rules, regulations and other administrative

issuance or parts thereof, inconsistent with the provisions of this Administrative Order, are
hereby repealed or modified accordingly.
SECTION 5 EFFECTIVITY

This Order shall take effect fifteen (15) days after its publication in two
newspapers of general circulation.

ANNOTATION: Section 11 (i) of R.A. No. 3720 as amended prohibits the manufacture, importation,
exportation , sale, offering of sale, distribution or transfer of any drug or device which is not
registered with the Bureau…”Therefore, generally speaking, there are only two (2)
situations when the safety, efficacy and therapeutic value of drug product may be evaluated
by BFAD,I.e. (1) when the drug product is sought to be registered or its registration is
sought to be renewed, in which case A.O. 67 s. 1989 will be applied; and (2) when the drug
or drug product is already registered and its safety, efficacy or therapeutic value is
questioned; In this latter case, the procedures prescribed by this A.O. 66 s.1989 will govern
the review and evaluation of the questioned drug.

There is, however, another set of rules governing fixed dose combination drugs, the A.O. 96
s. 1990, that can be considered as either an exception to the general rule or a
complimentary rule intended for the fixed dose combination drugs.

(Sgd) ALFREDO R.A. BENGZON

Secretary