The FDA Export Registration Requirements

By Jason Wang, eHow Contributor 

updated: August 04, 2010
1.

o The FDA imposes strict requirements for exports.

The Food and Drug Administration (FDA) is an agency of the United States government that protects and seeks to improve
public health by regulating and overseeing food safety standards, tobacco products, prescription and over the counter medication,
vaccines, medical devices and instruments, food quality and sets standards on the import and export of various goods. Specific
requirements and conditions for exports are listed in the Export Reform and Enhancement Act of 1996, which focuses on medical
drugs and medical devices.
2. General Export Requirements Under Export Reform and Enhancement Act
o All food, medicines, electronic devices, instruments, or cosmetics must be made according to the specifications
of the buyer, can not conflict with the laws of the country which the product is being exported to, has a label on the outside
packaging that it is intended for export and is intended for domestic sales. The FDA also has a right to regulate and enforce these
standards. This may include comparing the buyer's orders with the actual shipment and inspecting each shipment for quality control.
The FDA can also contact the country to which the shipment is being sent to make sure the shipment does not violate any of that
country's laws.
Types of Export Certificates
o The FDA issues certain certificates to exporters who meet their requirements for exports. The various
certificates are issued based on the products the exporter is exporting. The "Health Certificates for Food/Feed" is required primarily
for trade with countries within the European Union (EU). This certificate is generally not issued by the FDA. Instead, exporters must
directly inform the EU to receive this certificate after meeting EU's import requirements. The "Certificate of Pharmaceutical Products"
conforms to standards set by the World Health Organization and is required for the export of all medications, medical devices, and
other pharmaceuticals. The "Certificate to Foreign Government" is issued for the export of human drugs, animal drugs and other
devices that can be marketed in the United States.
Exports of Unapproved Drugs and Biological Products
o For drugs that have not been approved by the FDA for public release, exporters must prove their drug does not
violate the laws of the country to which they intend to export it. The foreign government must review the safety and effectiveness of
the drug. The reviewers must be medical experts who have experience in pharmaceuticals. The product must be labeled with a sign
of approval by the foreign government.

New Drug Application

From Wikipedia, the free encyclopedia

Regulation of therapeutic goods in

the United States

 Prescription drugs
Over-the-counter drugs

[show]Law
[show]Government agencies
[show]Process
[show]International coordination
[show]Non-governmental
organizations.

v · d · e

The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new

pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following:

 Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks?

 Is the drug’s proposed labeling (package insert) appropriate, and what should it contain?

 Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality

adequate to preserve the drug’s identity, strength, quality, and purity?

Contents

 [hide]

1 Before trials

2 Clinical trials

3 The actual application

4 Requirements for similar

products

5 References

6 See also
[edit]Before trials

To legally test the drug on human subjects in the U.S., the maker must first obtain an Investigational New Drug (IND) designation from FDA. This

application is based on pre-clinical data, typically from animal studies, that shows the drug is safe enough to be tested in humans.

Often the "new" drugs that are submitted are not new molecular entities, but old medications that have been modified.

[edit]Clinical trials

The legal requirement for approval is "substantial" evidence of efficacy demonstrated through controlled clinical trials.[1] This standard lies at the heart

of the regulatory program for drugs. It means that the clinical experience of doctors, the opinion of experts, or testimonials from patients, even if they

have experienced a miraculous recovery, have minimal weight in this process. Data for the submission must come from rigorous clinical trials.

The trials are typically conducted in three phases:

 Phase 1: The drug is tested in a few healthy volunteers to determine if it is acutely toxic.

 Phase 2: Various doses of the drug are tried to determine how much to give to patients.

 Phase 3: The drug is typically tested in double-blind, placebo controlled trials to demonstrate that it works. Sponsors typically confer with

FDA prior to starting these trials to determine what data is needed, since these trials often involve hundreds of patients and are very expensive.

 (Phase 4): These are post-approval trials that are sometimes a condition attached by the FDA to the approval.

The legal requirements for safety and efficacy have been interpreted as requiring scientific evidence that the benefits of a drug outweigh the risks and

that adequate instructions exist for use, since many drugs are toxic and technically not "safe" in the usual sense.

Many approved medications for serious illnesses (e.g., cancer) have severe and even life-threatening side effects. Even relatively safe and well

understood OTC drugs such as aspirin can be dangerous if used incorrectly.

[edit]The actual application

The results of the testing program are codified in an FDA-approved public document that is called the product label, package insert or Full Prescribing

Information.[2] The prescribing information is widely available on the web, from the FDA, [3] drug manufacturers, and frequently inserted into drug

packages. The main purpose of a drug label is to provide healthcare providers with adequate information and directions for the safe use of the drug.

The documentation required in an NDA is supposed to tell the drug’s whole story, including what happened during the clinical tests, what the

ingredients of the drug formulation are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and

packaged. Once approval of an NDA is obtained, the new drug can be legally marketed starting that day in the U.S.

Once the application is submitted, the FDA has 60 days to conduct a preliminary review which will assess whether the NDA is "sufficiently complete to

permit a substantive review". If the NDA is found to be insufficiently complete (and reasons for this can vary from a simple administrative mistake in the

application to a requirement to reconduct much of the testing), then the FDA rejects the application with the issue of a Refuse to File letter which is sent

to the applicant explaining where the application has failed to meet requirements. [4]
Assuming that everything is found to be acceptable, the FDA will decide if the NDA will get a standard or accelerated review and communicate the

acceptance of the application and their review choice in another communication known as the 74-day letter. [5] A standard review implies an FDA

decision within about 10 months while a priority review should complete within 6 months. [6]

Of original NDAs submitted in 2009, 94 out of 131 (72%) were in eCTD format.[7]

[edit]Requirements for similar products

Biologics, such as vaccines and many recombinant proteins used in medical treatments are generally approved by FDA via a Biologic License

Application (BLA), rather than an NDA. The manufacture of biologics is considered to differ fundamentally from that of less complex chemicals,

requiring a somewhat different approval process.

Generic drugs that have already been approved via an NDA submitted by another maker are approved via an Abbreviated New Drug

Application (ANDA), which does not require all of the clinical trials normally required for a new drug in an NDA. [8] Most biological drugs, including a

majority of recombinant proteins are considered ineligible for an ANDA under current US law. [9] However, a handful of biologic medicines, including

biosynthetic insulin, growth hormone, glucagon, calcitonin, andhyaluronidase are grandfathered under governance of the Federal Food Drug and

Cosmetics Act, which appears to be because these products were already approved when legislation aimed at regulating biotechnology medicines was

later passed as part of the Public Health Services Act.

Biologic medicines governed under the Federal Food Drugs and Cosmetics Act has been an area of considerable confusion and dispute for the FDA,

because under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, a "generic" need not be an exact duplicate of the brand-name original in

order to be approved. In July 2003, the Sandoz generics unit of Novartis filed, and the FDA accepted, an ANDA for a "follow-on" version of Pfizer's

brand-name human growth hormone (Genotropin) that that Sandoz named Omnitrope using the 505(b)(2) pathway. The application was submitted

following lengthy discussions with the FDA and contained preclinical, clinical, and comparability data, as well as literature references to the FDA's

original decision on Pfizer's Genotropin. But on September 2, 2004, the FDA told Sandoz that the Agency was unable to reach a decision on whether

to approve the company's application for Omnitrope. Frustrated with the FDA's failure to give them a decision on Omnitrope, Sandoz then sued the

FDA in U.S. District Court in Washington, D.C., citing a statutory requirement that the FDA is required by law to act on drug applications within 180

days. Medications intended for use in animals are submitted to a different center within FDA, the Center for Veterinary Medicine (CVM) in a New

Animal Drug Application (NADA). These are also specifically evaluated for their use in food animals and their possible effect on the food from animals

treated with the drug.

Medical devices are approved by a variety of methods depending on the class of the device. A Pre-market Application (PMA) largely equivalent to an

NDA is required for class III devices, and a 510(k) clearance that shows the device is "substantially equivalent " to a predicate device already on the

market is required for class II devices. In general, Class I medical devices (such as a toothbrush) do not require any approval at all.