New Drug

Development
and Approval
Process
 • Is the latest law that governs the regulatory activities
of the Food and Drug Administration of the
Food and Drug Philippines.

Administration • The law requires that the FDA must approve a new
drug before it may be legally introduced in
(FDA) Act of commerce.
• The law applies both to locally made and imported
2009 drugs.
• To gain approval for marketing, a drug’s sponsor
(e.g., a pharmaceutical company) must
demonstrate, through supporting scientific
evidence, that the new drug or drug product is
safe and effective for its proposed use.
• The sponsor must also demonstrate that the
various processes and controls used in
producing the drug substance and in
manufacturing, packaging, and labeling are
properly controlled and validated to ensure that
the product meets the established standards of
quality
General Process of Drug
Approval
• The process and time course from drug discovery to approval
for marketing can be lengthy and tedious but are well defined
and understood in the pharmaceutical industry.
Product Insert

• The content of a product’s

approved labeling, represented by
the package insert, is a summary
of the entire drug development
process because it contains the
essential chemistry,
pharmacology, toxicology,
indications and contraindications
for use, adverse effects,
formulation composition, dosage,
and storage requirements, as
ascertained during the research
and development
 • Special regulations apply for the approval of
Special Cases certain new drugs to treat serious or life-
threatening illnesses, such as AIDS and
cancer. These may be placed on an
accelerated or fast-track program for
approval.
 • Also, if there are no satisfactory approved drugs
or treatment alternatives for a serious medical
condition, special protocols may be issued
permitting the use of an investigational drug to
Special Cases treat some patients prior to approval of the
NDA.
• This type of protocol is termed a treatment IND.
• Treatment INDs often are sought for orphan
drugs, which are targeted for small numbers of
patients who have rare conditions or diseases
for which there are no satisfactory alternative
treatments
You may check approved treatment IND’s
here
• https://rarediseases.info.nih.gov/diseases/fda-orphan-drugs
Changes to an • Changes such as labeling or formulation change the
manufacturer needs to apply for SNDA (Supplemental New
approved drug Drug Application)
Generic Drugs

• An abbreviated new drug application (ANDA) is used to

gain approval to market a duplicate (usually a competing
generic product) of a product that is already approved.
• In these instances, the sponsor of the ANDA provides
documentation on the chemistry, manufacturing, controls,
and bioavailability of the proposed product to
demonstrate biologic equivalency to the original product
• Clinical data on the drug’s safety and efficacy are not
required because clinical studies were provided by the
pioneer sponsor.
FDA’S DEFINITION OF A NEW DRUG

• A new drug is any drug that is not recognized as being safe

and effective in the conditions recommended for its use in
the labeling among experts who are qualified by scientific
training and experience
• A drug need not be a new chemical entity to be considered
new. A change in a previously approved drug product’s
formulation or method of manufacture constitutes
newness under the law since such changes can alter the
therapeutic efficacy and/or safety of a product
• A combination of two or more old drugs or a change in the
usual proportions of drugs in an established combination
product is considered new if the change introduces a
question of safety or efficacy
• A proposed new use for an established drug, a new dosage
schedule or regimen, a new route of administration, or a
new dosage form makes a drug or a drug product’s status
new and triggers reconsideration for safety and efficacy.
SUPPLEMENT • A sponsor of an approved NDA may make
AL NEW changes in that application through the filing
of an SNDA
DRUG • Depending on the changes proposed, some
APPLICATION require FDA approval before implementing;
others do not. Among the changes requiring
prior approval:
• A change in the method of synthesis of the drug substance
• Use of a different facility to manufacture the drug substance
where the facility has not been approved through inspection for
Current Good Manufacturing Practice standards within the
previous 2 years
• Change in the formulation, analytical standards, method of
manufacture, or in-process controls of the drug product
• Use of a different facility or contractor to manufacture, process, or
package the drug product
• Change in the container and closure system for a drug product
• Extension of the expiration date for a drug product based on new
stability data
• Any labeling change that does not add to or strengthen a
previously approved label statement
 • In recognition of the international
INTERNATIONAL marketplace for pharmaceuticals and to
CONFERENCE ON achieve global efficiencies for both
regulatory agencies and the
HARMONIZATION pharmaceutical industry, the FDA,
OF TECHNICAL counterpart agencies of the European
Union and Japan, and geographic
REQUIREMENTS representatives from the pharmaceutical
FOR REGISTRATION industries has formed an organization
(ICH)
OF • With the long-range goal of establishing
PHARMACEUTICAL a uniform set of standards for drug
registration within these geographic
S FOR HUMAN USE areas
• The ICH’s work toward uniform standards is focused on three
general areas—quality, safety, and efficacy.