This executive decree modifies regulations regarding the health registration of biological and biotech products in Panama. It establishes new requirements for registering biotech products, including presenting clinical trial data, quality and manufacturing information, risk management programs, and certificates of analysis for each imported batch. Biotech products already registered must now present clinical trials within 60 days to maintain their registration. The decree aims to ensure the efficacy, safety and quality of biopharmaceuticals marketed in Panama.

1. REPUBLIC OF PANAMÁ MINISTRY OF HEALTH
EXECUTIVE DECREE No. 340 (August 27, 2007 )
"Which modifies Chapter V, Title II of Executive decree 178 of July
12, 2001, regulating Act 1 of January 10, 2001, on drugs and other
products for human health "
THE PRESIDENT OF THE REPUBLIC, by the constitutional and
legal authority invested in him,
CONSIDERING:
That Act 1 of 10 of January 10, 2001, on drugs and other products
for human health, establishes a mandatory health registration and
batch control for biological products;
That it is an essential function of the National Direction of Pharmacy
and Drugs of the Ministry of Health to watch over the efficacy,
quality and safety of pharmaceutical products marketed in our
national territory;
That, as established in number 3, article 17 of Act 1 of 10 of January
10, 2001, the Technical Consulting Commission of the National
Direction of Pharmacy and Drugs includes among its functions to
propose, for consideration by the Health Authority, projects for
regulation regarding efficacy testing, formulation changes, stability
studies, bio- engineering products, therapeutic equivalence, clinical
trials and any other required by the Authority;
That number 6, article 25 of Act 1 of 10 of January 10, 2001
empowers the Health Authority to regulate products requiring
presentation of clinical trials as a basic requirement for health
registration;
That article 45 of the Executive Decree 6 of February 21, 2005,
which regulates Chapter IV Title II of Act 1 of 10 of January 10,
2001, regarding therapeutic equivalence, states that the Health
Authority will define specific regulation to establish the
exchangeability of biological and biotech products;
That, in light of current scientific knowledge, it is impossible to
establish exchangeability of biotech products, making it necessary to
adapt the requirements for the health registration of these products,

2. to guarantee their efficacy, safety and quality.
DECREES: Article 1. Chapter V Title II of Executive Decree 178
of July 12, 2001, is modified to read as follows:
CHAPTER V HEALTH REGISTRATION OF BIOLOGICAL
AND BIOTECH PRODUCTS SECTION I OF BIOLOGICAL
PRODUCTS
Article 69. To obtain a health registration for biological products, the
regulations stated in Section 1, “Basic Requirements” of Chapter I,
"Process to obtain a health registration", of Title II, "Of Drugs and
Pharmaceutical products", of Executive Decree 178, must be
observed, in addition to compliance with what the Expert Committee
on Biological Products of the World Health Association has
established, and, in applicable cases, norms set by other regulatory
authorities or organisations, such as the US Food and Drug
Administration (FDA), International Conference for Harmonisation
(ICH) and the European Medication Evaluation Agency (EMEA).
Article 70. Monographs of biological products, in addition to what
has been stated in Article 14 of Executive Decree 178, should
indicate the following: a) Quantitative product description
expressed in mass, in international units, biological activity units, or
protein content (if possible), according to the type of product. When
a diluent is present, this must be described (this information must be
included in the secondary package label).
b) Specifications for sources and techniques or procedures used to
obtain it. c) Procedures used to endure as mush as possible the
absence of potentially pathogenic agents, which could be transmitted
through this type of medication (precaution for cross-
contamination). d) Controls developed during the manufacture
process.
e) Information on precautions that must be taken by people handling
or manipulating them, as well as those that must be observed by
patients. f) Information about how to dispose of waste products.
Article 71. In the secondary package label, besides requirements
stated in Article 38 of Executive Decree 178, the following should
be described: a) The nature and number of excipients adjutants,

3. preservatives and/or any other added substance that might cause an
adverse reaction.
b) The dose and number of doses contained per package, and the
source. c) The diluent used for reconstitution (when applicable). d)
Precautions and warnings as corresponds. e) Symbols and phrases
with warnings about the need for cold storage.
SECTION II OF BIOTECH PRODUCTS
Article 71-A. Biotech products for human consumption are defined
as biological protein products developed through genetic
engineering, obtained using recombinant nucleic acid (DNA and
RNA) combination techniques, monoclonal antibodies and
others. Article 71-B. To obtain a Health Registration for biotech
products, the following is required:
a) A formal request presented by an attorney. b) Certificate of
Pharmaceutical Product, World Health Organization type, issued by
the health authority of the country of origin or Certificate of Free
Sale and corresponding Certificate of Good Manufacturing
Practices, both issued by the health authority of the country of
origin. c) Labels and packaging d) Monograph of the product to
be registered e) Samples f) Quali-quantitative formula g)
Analysis method h) Certificate of Analysis i) Specifications of
sources and techniques or procedures used to obtain the active
principle j) Process for manufacturing the finished product, and
product specifications to guarantee batch-to-batch uniformity k)
Procedures used to ensure as much as possible the absence of
potentially pathogenic agents or immune reactions l) Analytical
patterns when required m) Product stability studies. Those
requiring reconstitution must present stability studies before and
after reconstitution n) Conditions for storage, distribution and
transportation. o) Clinical trials showing safety, efficacy and
quality of the product, or comparative trials versus the innovator
product p) Risk management programme and drug surveillance
plan q) Prior control r) Approval by a qualified pharmacist; it can
be the Regent Pharmacist s) Approval by the National Pharmacist
College
Article 71-C. Clinical trials mentioned in point "o" of article 71-B of

4. this Executive Decree should be phase I, II and III clinical trials. As
for comparative trials, these will include clinical, non-clinical and
quality aspects, in order to determine its similarity to the innovator.
Article 71-D. The National Direction of Pharmacy and Drugs will
take, as a reference for assessing clinical and comparative trials,
recommendations from the Expert Committee on Biological
Products of the World Health Association, and technical guidelines
from other regulatory authorities and organisations, e.g. the US Food
and Drug Administration (FDA), the International Conference for
Harmonisation (ICH) and the European Medication Evaluation
Agency (EMEA).
Article 71-E. Monographs of biological products, in addition to what
is stated in article 14 of Executive Decree 178, should indicate the
following:
a) Quantitative product description expressed in mass, in
international units, biological activity units, or protein content (if
possible), according to the type of product. When a diluent is
present, this must be described (this information must be included in
the secondary package label). b) The nature and amount of
excipients and any other substance that might cause an adverse
reaction.
c) Sources of raw materials d) Instructions for preparation,
management and administration of the product e) Information about
how to dispose of waste products f) Storage and transportation
conditions
Article 71-F. In the secondary package label, besides requirements
stated in Article 38 of Executive Decree 178, the following should
be described: a) The dose and number of doses contained per
package b) The diluent used for reconstitution (when applicable)
c) Precautions and warnings as corresponds d) Symbols and
phrases with warnings about the need for cold storage.
Article 71-G. For import or marketing, the Certificate of Analysis
will be required for each batch of product, issued by the person
responsible for Quality Assurance for the manufacturing lab or
license holder.

5. Article 71-H. Biotech products that already have registrations and
those that have already started the registration process, which have
not presented clinical trials, must present them as stated in point "o"
of article 71-B of this Executive Decree, within sixty (60) calendar
days. Not complying with this requirement will be a cause for
suspending the health registration.
Article 71-I. All license holders of biotech products already
approved or undergoing approval must present a risk management
programme and a drug surveillance plan within 60 calendar days,
which must consider all risks identified during product development
and potential risks during use.
Article 2. This Executive Decree is valid starting on the date of its
publication in the Official Legal Journal. Issued in Panama City,
August 27, 2007.
LET IT BE COMMUNICATED AND OBSERVED
CAMILO A. ALLEYNE Ministry of Health
MARTIN TORRIJOS ESPINO President of the Republic