Medicine

The U.S. Food and Drug Administration secures the effectiveness of food and drugs, promotes the supply of safer and less expensive products to their own citizens, and provides accurate and scientifically based information necessary for the use of drugs and foods to maintain and improve public health. We are promoting public health by helping you get it.

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  Application type

  There are two categories of Investigational New Drug application (IND) for sale and for research (non-sale). There are three types of application :

  1. Researcher IND(Investigational New Drug application)

  The application is submitted by the doctor who initiates and conducts the clinical trial, and the investigational drug is administered or dispensed under the direct' direction of the doctor. Doctors may submit an application for approval of a research trial plan to propose a trial for an unlicensed drug or a drug for a new indication or a new patient population.

  2. IND(Investigational New Drug application) for Emergency Use

  The application allows the U.S. Food and Drug Administration to authorize the use of the test drug in situations where time is not allowed for approval of a clinical trial plan pursuant to Article 312.23 or 312.34 of the Code of Federal Regulations. It can also be used for patients who do not meet the conditions of an existing trial plan, or if no approved trial plan exists.

  3. IND(Investigational New Drug application) for treatment purposes

  The application is submitted for an investigational drug that has the prospect of severe or immediate life-threatening symptoms in the clinical trial when a clinical trial is being conducted and a review by the U.S. Food and Drug Administration is in progress. In the case of severe disease, drugs in phase 3 clinical trials or all clinical trials have been completed can be used for treatment according to this section. In the case of immediate life-threatening diseases, even before phase 3 clinical trials, the drug may be available for treatment pursuant to this section unless it is usually prior to phase 2 clinical trials.

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  How to register

  Establishment in a foreign country involved in manufacturing, preparation, dissemination, synthesis or processing of drugs (particularly including repackaging and relabeling) imported or provided for import into the United States (with no exceptions) must participate in initial activities. You must register immediately and register annually.
  
  Drug registration amendments must be submitted in accordance with 21 CFR 207.26
  
  Section 510 of the Act and Part 207 of 21 CFR provide registration information required to be submitted by domestic and international drug establishments. Under these regulations, all registrants must specify the name and full address of each facility, any trade name used in the establishment, the type of title or business (e.g., individually owned, jointly owned or legal), the name of the owner or the operator's name ( In the case of joint ownership, the name of each partner must be included; in the case of a legal entity, the name and the name and title of each officer and director, and the state of the corporation) must be provided.

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  Specific additional information

  In addition to the information required for all registered establishments, certain additional information must be provided in order to register a foreign establishment.
  
  For example, foreign registrants must submit :

  • Name, address, and phone number of the foreign registrant's U.S. agent
  • The name of each importer known to the facility (this means each U.S. company or individual is the owner, consignee, or recipient of the drug in an outpatient facility that is imported into the U.S. Importers do not include customers or patients who ultimately purchase, receive, or administer drugs, unless a foreign facility directly ships the drug to the customer or patient.)
  • The name of the person who imports or provides the drug (this means the name of each agent, broker, or other entity other than the carrier that foreign drug establishments use to facilitate the import of their drugs into the United States)

  To facilitate the registrant's and FDA's response, you must provide an email address of the importer's U.S. agent and phone number and email address of the importer you provide to import or import foreign registrants.
  
  Registrants must submit additional drug facility registration information using Form FDA 2656.16. Likewise, for electronic submissions, registrants must submit the following additional information in their SPL file :

  • Official contractor name, address, phone number, e-mail address
  • Type of work performed at each facility

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  Drug list

  • ☑ Registrants must provide initial inventory information for all commercially distributed drugs upon initial registration of the facility.
  • ☑ Failure to provide any inventory information required by Act 510(j) pursuant to Section 301(p) of Act is a prohibited act and, in addition, if the inventory required by Section 502(o) of Act is not included, the drug It is marked with an unauthorized trademark.
  • ☑ FDA does not accept drug facility registration information from private label distributors (PLDs), but PLDs may request their own NDC label code and submit drug listing information to the FDA.
  • ☑ By submitting drug listing information, PLD assumes full responsibility for compliance with listing requirements.
  • ☑ In this case, when submitting or updating drug listing information, private label distributors must manufacture, prepare, disseminate, synthesize or process (especially, including repackaging and relabeling) the listed drugs. You must prove your registered facility.
  • ☑ For certification of registered facilities by private label distributors, paper format can be used.
  • ☑ If a drug product is listed by PLD, it is also by the owner of a registered facility that manufactures, prepares, disseminates, synthesizes or processes (including, in particular, repackaging and relabeling) the listed drug. It should not be listed.
  • ☑ Registrants (and private label distributors, if applicable) must update their drug listing information and ensure that drugs have not been previously listed and introduced for commercial distribution.

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  IGC’s Competency

  • IGC supports exports of pharmaceuticals to the US with many years of rich experience.
  • Drug FDA registration, drug label review, IND, NDA, ANDA, NADA, ANADA, OTC registration, NDC registration, SPL preparation, and manufacturing facility GMP compliance services.
  • IGC is quick and results-oriented, and provides certification audits through certification bodies and post-certification enhancement/maintenance services to help organizations make the most of GMP quality management.