The FDA Export Registration Requirements

By Jason Wang, eHow Contributor updated: August 04, 2010



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
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
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
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

This standard lies at the heart of the regulatory program for drugs.S. and what should it contain? Are the methods used in manufacturing (Good Manufacturing Practice. Data for the submission must come from rigorous clinical trials. strength. typically from animal studies.. the opinion of experts. [edit]Clinical trials [1] The legal requirement for approval is "substantial" evidence of efficacy demonstrated through controlled clinical trials. 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. have minimal weight in this process.Prescription drugs Over-the-counter drugs [show]Law [show]Government agencies [show]Process [show]International coordination [show]Non-governmental organizations. and do the benefits of the drug outweigh the risks? Is the drug¶s proposed labeling (package insert) appropriate. or testimonials from patients. 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. 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. that shows the drug is safe enough to be tested in humans. but old medications that have been modified. . GMP) the drug and the controls used to maintain the drug¶s quality adequate to preserve the drug¶s identity. It means that the clinical experience of doctors. Often the "new" drugs that are submitted are not new molecular entities. quality. the maker must first obtain an Investigational New Drug (IND) designation from FDA. This application is based on pre-clinical data. even if they have experienced a miraculous recovery.

[edit]The actual application The results of the testing program are codified in an FDA-approved public document that is called the product label. including what happened during the clinical tests. Generic drugs that have already been approved via an NDA submitted by another maker are approved via an Abbreviated New Drug Application (ANDA). what the ingredients of the drug formulation are. Once approval of an NDA is obtained. 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. which does not require all of the clinical trials normally required for a new drug in an NDA. rather than an NDA. processed and packaged.S.  (Phase 4): These are post-approval trials that are sometimes a condition attached by the FDA to the approval.g. and how it is manufactured. 94 out of 131 (72%) were in eCTD format. the new drug can be legally marketed starting that day in the U. since these trials often involve hundreds of patients and are very expensive. how the drug behaves in the body. [2] [3] The documentation required in an NDA is supposed to tell the drug¶s whole story. 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. 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). [edit]Requirements for similar products Biologics. [4] Assuming that everything is found to be acceptable. drug manufacturers. Phase 2: Various doses of the drug are tried to determine how much to give to patients. since many drugs are toxic and technically not "safe" in the usual sense.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.. package insert or Full Prescribing Information. the results of the animal studies. including a . Phase 3: The drug is typically tested in double-blind. 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. the FDA has 60 days to conduct a preliminary review which will assess whether the NDA is "sufficiently complete to permit a substantive review". Sponsors typically confer with FDA prior to starting these trials to determine what data is needed. from the FDA. [8] Most biological drugs. requiring a somewhat different approval process. Many approved medications for serious illnesses (e. such as vaccines and many recombinant proteins used in medical treatments are generally approved by FDA via a Biologic License Application (BLA). Even relatively safe and well understood OTC drugs such as aspirin can be dangerous if used incorrectly. [7] [6] [5] Of original NDAs submitted in 2009. and frequently inserted into drug packages. Once the application is submitted. cancer) have severe and even life-threatening side effects. A standard review implies an FDA decision within about 10 months while a priority review should complete within 6 months. The main purpose of a drug label is to provide healthcare providers with adequate information and directions for the safe use of the drug. placebo controlled trials to demonstrate that it works. The prescribing information is widely available on the web. The manufacture of biologics is considered to differ fundamentally from that of less complex chemicals.

and the FDA accepted.majority of recombinant proteins are considered ineligible for an ANDA under current US law. because under section 505(b)(2) of the Federal Food. andhyaluronidase are grandfathered under governance of the Federal Food Drug and Cosmetics Act. District Court in Washington. Medications intended for use in animals are submitted to a different center within FDA. 2004. Drug. as well as literature references to the FDA's original decision on Pfizer's Genotropin. Sandoz then sued the FDA in U. But on September 2. a "generic" need not be an exact duplicate of the brand-name original in order to be approved.. Medical devices are approved by a variety of methods depending on the class of the device. Class I medical devices (such as a toothbrush) do not require any approval at all. citing a statutory requirement that the FDA is required by law to act on drug applications within 180 days. D.S. In general. . the Sandoz generics unit of Novartis filed. [9] However. calcitonin. the Center for Veterinary Medicine (CVM) in a New Animal Drug Application (NADA). including biosynthetic insulin. These are also specifically evaluated for their use in food animals and their possible effect on the food from animals treated with the drug. glucagon. Frustrated with the FDA's failure to give them a decision on Omnitrope. clinical. 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. a handful of biologic medicines. A Pre-market Application (PMA) largely equivalent to an NDA is required for class III devices. and comparability data.C. Biologic medicines governed under the Federal Food Drugs and Cosmetics Act has been an area of considerable confusion and dispute for the FDA. 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. 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. and Cosmetic Act. In July 2003. the FDA told Sandoz that the Agency was unable to reach a decision on whether to approve the company's application for Omnitrope. The application was submitted following lengthy discussions with the FDA and contained preclinical. growth hormone.

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