Category: fda registration drug

GENERIC DRUGS – AN OVERVIEW

A generic drug is a medicine created to be the equivalent to an already marketed brand-name drug in dosage form, safety, strength, route of administration, feature, physical characteristics, and intended use. The similarities between generic drug and brand-name medicine helps to demonstrate bio-equivalence, which shows  that a generic medicine works in the same way and gives the same clinical benefit as its brand-name type. In other words, generic medicine can be taken as an equal substitute for its brand-name equivalent.  FDA Generic Drugs program conduct inspections of manufacturing plants every year and monitor the drug safety after it has been approved and marketed.

Even though generic drugs and brand-name drugs share the same active ingredients, safety, strength, efficiency and the intended use, the trademark laws in the United States do not allow them to have the same look exactly like other drugs which is already on the market.

Cost difference between Generic medicine and Brand-name medicine

Companies that develop new drugs, like other new products are protected by patents that restrict other companies from manufacturing and marketing the same drug. The patent protects the company’s investment in developing the drugs by giving the sole right to market the drug till the patent is in effect.  FDA allows certain period of marketing exclusively the brand-name medicine till the patents and marketing exclusive rights expire. After that, it approves the generic version of the same drug.  Generic drugs cost less than their brand-name equivalent because they do not need to repeat animal and clinical studies that were required for brand-name drugs to demonstrate its safety and efficiency.  This is also known as “abbreviated new drug application.” The competition between the brand-name drug and multiple generic drugs is the main reason for low-cost generic drug.

Demonstration of ANDA

ANDA must demonstrate the generic medicine is equivalent to its brand-name counter part by the following ways.

  • Contain the same active ingredients as the brand-name drug. Active ingredients make the drug effective against the disease or condition it is treating. Inactive ingredients may vary.
  • Be identical in strength, dosage form and route of administration. If the brand-name drug is a capsule and is taken orally, so is the generic.
  • Treat the same medical condition.
  • Be absorbed into the bloodstream at a similar rate and over the same period of time.
  • Meet the same requirements for identity, strength, purity and quality.
  • Be manufactured under the same strict standards that FDA demands of brand-name drugs.

FDA will make sure that the medicines both generics and brand- name sold in the United States are safe and effective by conducting testing in its laboratories or through research contract and grants.  Also FDA encourages physicians and consumers to notify FDA of any adverse side effects when using the drugs and medical devices which FDA regulates by reporting them at MedWatch.

Liberty Management Group , a leading FDA consulting firm in the United States provides assistance with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consutltant

Mail : office@libertymanagement.us

http://www.fdahelp.us

CERTIFICATE TO FOREIGN GOVERNMENT (CFG)

Certificate to Foreign Government (CFG) is document prepared by FDA issued for legally marketed devices in the U.S that are in compliance with the regulations of FD&C act.

Medical devices that are legally marketed in the United States can be exported to anywhere in the world without getting approval from FDA.  Although FDA does not restrict the export of legally marketed, certain importing countries require a certification from FDA stating that the firm, or its devices are in compliance with U.S. FDA regulations. Foreign government will ask for official assurance that the products exported to their countries are in compliance with US FDA regulations such Good manufacturing Practice (GMP) requirements. In that cases, U.S companies can request a certificate to foreign government (CFG) also known as Certificate of Free sale to FDA.

The certificate to foreign government (CFG) is a self-certification process. By completing the required form, a firm confirms that it is registered with FDA and listed their device with FDA, that each product is legally marketed in the U.S. and is not the subject of an open recall, that all facilities involved in the manufacturing process are complying with the FDA’s regulations, and that each product is being exported from the U.S.

Requirements to get the Certificate to Foreign Government (CFG)

  1. The manufacturing facility must have a valid medical device establishment registration
  2. All devices must be listed with FDA
  3. The devices must have cleared Premarket notification (510K) or Premarket Approval (PMA) unless it is exempted by the regulation.
  4. The device should meet all the medical device labelling requirements as of 21 CFR 801 and 809.
  5. The device should be manufactured in accordance with 21CFR 820 also known as Good Manufacturing practice unless it is exempted by the regulation.

Certificate to Foreign government can be requested through CECATS system.  It is a voluntary electronic system that allows the manufacturers and initial importers to request export documents online. CECATS can be accessed by logging into FDA Furls account.

The fees for export certificate from CDRH is $175 for the first certificate and $85 each for additional certificate upon the request from the customer.

Liberty Management Group, a leading FDA consulting firm provides assistance with FDA Medical device registration, device listing and certificate to foreign government application.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us

http://www.fdahelp.us

OVER-THE-COUNTER (OTC) DRUG PRODUCTS

Over-the-Counter drugs (OTC)  also known as nonprescription drugs are medications sold directly to consumers without a prescription from a physician. OTC drugs are in general considered as safe and effective for use by the consumers without getting treatment from a healthcare professional.  There are more than 300,000 OTC drugs are marketed with about 800 active ingredients.

Although there are more than 80 therapeutic categories of OTC drugs, starting from acne products to weight management drugs, FDA is not approving OTC products, but Center of Drug Evaluation and Research (CDER) ensures that OTC drugs are properly labeled and its ingredients listings. For each category, FDA developed an OTC drug monograph and published in the Federal Register. OTC drug monograph provided guidance which covers doses, acceptable ingredients, formulations and labelling requirements.  When the company adheres to OTC monograph, it can make and market an OTC drugs without FDA’s pre-approval.  OTC monographs defines the safety, efficiency and labeling of all OTC active ingredients. The drugs for which the active ingredients is not OTC monograph, has to apply for New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

FD&C acts requires firms that manufacture, contract manufacture, repack or re-label or salvaging of OTC drugs in the United States or that are offered for import in the U.S are required to register with FDA and renew their registration annually. Also domestic and foreign establishments must list all drugs that they manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Foreign firms are required to identify a U.S agent and importers at the time of registration.

FDA Drug establishment registration needs to be submitted electronically using Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. The firms must use FDA’s Electronic Submission Gateway (ESG) to submit SPL files.

Private Label Distributors (PLD) are not required to register their establishment with FDA, however they have to apply for their own Labeler code and list their drugs with FDA. FDA has a released a list of summary of registration and listings requirements for the manufacture or distribution of human pharmaceuticals, which can be seen at https://www.fdahelp.us/Pdf/Drug.pdf

Drug establishments that are registered with FDA must list all the products they manufacture for commercial distribution under their own labeler code, which includes the API manufacturers, bulk manufacturers, contract manufacturers, re-packers and re-labelers.

FDA has published a regulation establishing standardized content and format for the labeling of OTC drug products (Drug Facts labeling). The Drug Facts labeling for OTC drug products is intended to make it easier for consumers to read and understand OTC drug product labeling and use OTC drug products safely and effectively. All drugs or drug products in finished package form is considered as misbranded if it does not comply with FDA labeling requirements.

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

DMF – DRUG MASTER FILES

A Drug Master File (DMF) is a document submitted by a drug manufacturer to US FDA which is used to provide confidential detailed information about facilities, procedures, or things used in the manufacturing, processing, packaging, and storing of one or more human drugs. A DMF is submitted when more companies work in partnership to manufacture a drug product, which allows the company to protect is its intellectual property rights from its partner while complying with regulatory constraints as well for disclosing of processing procedures.

DMF’s are submitted to support regulatory regulations and prove the quality, safety and effectiveness of a product for getting Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application(ANDA), another DMF and Export Application. However, DMF submission is NOT a substitute for an IND, NDA, ANDA or Export Application. As per FDA regulation, DMF submission is not required by law, it is solely depends to submitters discretion.

As per FDA, there are five types of DMF’s

  • Type I  : Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II  : Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III :  Packaging Material
  • Type IV  : Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V :  FDA Accepted Reference Information

All DMF submissions must be in the English language which should contain transmittal letter, administrative information about the submission and must include specific information about the DMF type.

All foreign DMF holders are required to appoint an U.S agent, however domestic DMF holders do not need a representative to submit it.

DMF holders should submit an annual report on the same date of their original submission.  Annual report should contain all the information including name and address of DMF holder, corporate headquarters, Manufacturing/ processing facility, contact for FDA communication, agents (if any),statement of commitment and signed statement by the DMF holder assuring that the DMF is current.

Starting from May 5, 2018 onwards, new DMFs other that Type III, as well as all documents submitted to existing DMFs excluding Type III are required to submit DMF using Electronic Common Technical Document (eCTD).  DMFs that are not submitted through eCTD after May 5, 2018 will be rejected, however for Type III DMFs the requirement will be effective from May 5, 2020 onwards.

Liberty Management Group Ltd, a leading FDA consulting group in the United States, provides assistance DMF eCTD submissions, US agent service, DMF closure and reactivation request submission to FDA.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

DRUG LABELING

Drug label is a printed information which is included with any OTC drugs, prescription drugs or any dietary supplements. Drugs labels are regulated by FDA and provide information to healthcare providers and patients on safe and effective use of the product. The information on the labels must be accurate and should not be misleading

All drugs or drug products in finished package form is considered as misbranded if it does not comply with FDA labeling requirements. The labels needs to have the name and place of business of the manufacturer, packer or distributor.

All registered drug establishments which includes API manufacturer, bulk manufacturer, contract manufacturer, repackers, relabelers are required to list their products under their own labeler code, however NDC number is not required to appear on all drug labels, including the label of any prescription drugs given to a customer.

Drugs labels should contain all drug facts which includes active ingredients, purpose and uses of the drug, directions, other information, inactive ingredients, phone numbers if there is any questions or comments.

When there is an expiration date on the drug products, it should appear on the container and also in outer package. However, if it is a single dose drug product packed in individual cartons, the expiry date should be on the individual carton not on the product container.

Manufacturers, Contract manufacturers, repackers, relabelers, and private label distributors of a human prescription drugs or an over-the-counter (OTC) drugs that is regulated under the FD&C act are not required to have bar code on the products. However, if the same drug product that are sold or used in the hospitals are required to put bar code on their products.

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

HOMEOPATHIC DRUG REGISTRATION AND LISTING WITH FDA

Homeopathy is an alternative medicine created by a German Scientist which claims that a substance that causes the symptoms of a disease in healthy people would cure similar symptoms in sick people.

Any drugs labeled as homeopathic has to be listed in the Homeopathic Pharmacopeia of the United States (HPUS).

FDA does not approve products labeled as homeopathic products. The products labeled as homeopathic contains a range of substances resulting from plants, healthy or dead animal or human sources, minerals and chemicals.

Homeopathic products currently marketed here in US have not been reviewed by FDA to check its safety and effectiveness to treat, diagnose, cure or prevent any disease or conditions.

Under FD&C act, Homeopathic drugs products are subject to same regulations as OTC drugs.

As per FDA, companies which manufacture, prepare, propagate and compound homeopathic drugs must register with FDA as drug establishment and list their drugs with FDA by creating a SPL.

Homeopathic drug product labeling must comply in same regulations as any other drugs products.

Liberty Management Group Ltd, provides assistance with homeopathic drugs establishment registration, drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us.

www.fdahelp.us

COMPOUNDING PHARMACY REGISTRATION

Compounding is a method of mixing, combines or alters ingredients of a drug to manufacture a medication custom made to the needs to individual patient under the supervision of licensed pharmacist, or a licensed physician or an outsourcing facility.

Compounded drugs are not FDA-approved. FDA does not check these drugs to assess their safety or efficiency before they reach patients. It is only the responsibility of State board of pharmacy to monitor state-licensed pharmacies that compound drugs in accordance with regulation of section 503A of the FD&C, although FDA has some control over their operations.

Outsourcing facilities registered under section 503B are regulated by FDA and must stratify cGMP requirements and will be inspected by FDA.

An outsourcing facility is geographic location or address where the drugs are compounded. An outsourcing facility has to be in compliance with section 503B and must comply with cGMP requirements.

If an outsourcing facility engages in compounding non-sterile drugs and animal drugs, mixing, diluting or repacking biological products do not need to register as an outsourcing facility as the drugs compounded are not eligible for exemption form 503B for FD&C act.

All Outsourcing facilities that engages in compounding sterile human drugs needs to register with FDA using CEDR system.

All outsourcing facilities must renew their registration between Oct 1st and Dec 31st and pay the annual establishment registration fees for every year as long as they wish to register as an outsourcing facility.

PRODUCT REPORTING PROCEDURES

The drug products manufactured from December 1 through May 31 must submit drug product reporting between June 1 and June 30. In the same way, the drug products manufactured from June 1 through November 30 must submit drug product reporting between December 1 and December 30.

Each product report must include all sterile and non-sterile drug compounded in the outsourcing facility must include active ingredient and its strength, NDC number of source drug or bulk active ingredient, dosage and route of administration, package description, number of individual units manufactured and NDC number of end product (If assigned)

LMG provide assistance with FDA registration of Outsourcing facilities.

Sudha S

Regulatory Consultant

Mail – office@libertymanagement.us

http://www.fdahelp.us

Published on: January 9, 2019