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The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs in the United States. An ANDA is a request to the FDA to manufacture and market a generic drug, and is abbreviated since it does not require clinical trials like a New Drug Application. The key points covered include basic generic drug requirements, the objective of reducing drug costs, comparisons between innovator and generic drugs and between NDAs and ANDAs, the Hatch-Waxman Act of 1984 which established the ANDA pathway, patent certification requirements, and an overview of the ANDA review process.
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The document discusses the abbreviated new drug application (ANDA) regulatory approval process for generic drugs in the United States. It describes the key steps and reviewing bodies involved, including filing review by the Regulatory Support Branch, coordination of reviews by bioequivalence, chemistry, and labeling teams, and final approval. The primary goal of the ANDA process is to determine if the generic drug is bioequivalent to the reference listed drug while ensuring safety and manufacturing quality standards are met.
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The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs. It provides background on the Hatch-Waxman Act of 1984 which established the ANDA pathway. The key points are:
1. The Hatch-Waxman Act aimed to balance innovation and access to medicines by providing incentives for brand and generic drug companies. It allowed generics to rely on brand safety data and established bioequivalence standards.
2. ANDAs contain data to demonstrate a generic drug is bioequivalent to the brand version. This allows generics to enter the market without duplicative clinical trials, lowering costs.
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DMF Drug Master File
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
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The document discusses the Abbreviated New Drug Application (ANDA) process for generic drugs. It provides background on the Hatch-Waxman Act of 1984 which established the ANDA pathway. The key points are:
1. The Hatch-Waxman Act aimed to balance innovation and access to medicines by providing incentives for brand and generic drug companies. It allowed generics to rely on brand safety data and established bioequivalence standards.
2. ANDAs contain data to demonstrate a generic drug is bioequivalent to the brand version. This allows generics to enter the market without duplicative clinical trials, lowering costs.
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Hatch waxman act & amendments ppt
The Hatch-Waxman Act established an abbreviated approval pathway for generic drugs that relies on the safety and efficacy evidence of the branded reference drug. It aims to balance incentives for innovation and generic competition. The Act created ANDAs that allow generics to enter the market after patents and exclusivities expire. It also provides the branded drug up to 30 months to litigate patents against Paragraph IV ANDA challenges and restores some patent term lost during regulatory review.
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DMF Drug Master File
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
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The document provides an overview of the New Drug Application (NDA) process used in the United States to gain approval for new drugs. It discusses how the NDA process has evolved since 1938 to require evidence of both safety and efficacy. It also describes the various sections required in an NDA, including summaries of clinical data, chemistry and manufacturing, labeling, and safety information. The review process for an NDA by the FDA is also summarized, including timeframes for filing and reviewing an application.
Anda
This document summarizes the regulations and history around generic drug applications (ANDAs) in the United States. It explains that an ANDA is an application to produce a generic version of an approved drug that is the same in dosage, strength, and use. The document outlines the basic requirements for generic drugs and discusses the historical approval pathways including ANDAs, paper NDAs, and monographs that preceded the modern system established by the Hatch-Waxman Act of 1984. This law standardized the ANDA process and established provisions to balance generic competition with patent protections for brand drugs.
PMS (post marketing surveillance)
This document discusses post-marketing surveillance (PMS), which refers to monitoring drugs after they have been approved for public use. PMS is important because clinical trials have limitations in terms of patient population size, duration, and ability to detect rare or long-term effects. Sources of PMS information include spontaneous reporting, studies using medical databases, and manufacturer monitoring. Common PMS methods include spontaneous reporting of adverse drug reactions, cohort studies, and case control studies. PMS can help identify new safety issues and provide more information on drug risks and benefits in diverse patient populations.
Medical & Healthcare Products Regulatory Agency (MHRA)
The MHRA is a UK government agency responsible for regulating medicines and medical devices. It was formed in 2003 by merging the Medical Control Agency and Medical Devices Agency. The MHRA aims to protect public health by regulating products to ensure acceptable safety and efficacy profiles. It also aims to educate the public about risks and benefits of products. The MHRA board is composed of a non-executive chairman, six non-executive members, and the agency's chief executive officer. Key functions of the MHRA include regulating clinical trials, assessing safety and efficacy of products for marketing authorization, inspecting manufacturers, and enforcing statutory guidelines.
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Regulatory requirements for new drug approval are in place to ensure medications are safe and effective for consumers. Regulatory affairs evaluate drug development, production, and marketing. Key functions include monitoring legislation changes and ensuring manufacturing and marketing practices comply with regulations. Stringent approval processes were implemented after tragic incidents revealed drug safety issues. Notable regulatory bodies include the FDA in the US and CDSCO in India. Approval involves non-clinical and clinical trials to assess safety, efficacy, and quality before marketing applications like an NDA can be submitted for review. Compliance with regulatory standards is necessary throughout the drug development and approval process.
ANDA
The document provides information about abbreviated new drug applications (ANDAs), which are designed to allow approval of generic drug products that are equivalent to already approved brand name drugs. An ANDA must show a generic drug is comparable to the reference drug in dosage form, strength, quality and performance. It does not require preclinical and clinical trials but must demonstrate bioequivalence through bioavailability and bioequivalence studies. The ANDA contents and review process are outlined according to the Common Technical Document format in five quality, nonclinical, and clinical modules.
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eCTD
This document discusses electronic submission of drug applications using the electronic common technical document (eCTD) format. It provides an overview of eCTD, including its module structure and requirements. The key points covered are:
- Regulatory agencies now prefer eCTD format over paper submissions for drug applications due to benefits like reduced storage needs, increased accountability and easier review.
- eCTD format organizes information into modules covering administrative data, summaries, quality documentation, non-clinical and clinical studies reports.
- The document provides guidance on creating an eCTD submission, including use of the required eCTD software and structure, and submitting a test filing to address any issues before final submission.
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This document discusses the differences between sustained release and controlled release drug formulations and their mechanisms of drug delivery. Sustained release aims to slowly release drug over 8-12 hours, while controlled release delivers drug at a predetermined rate according to bodily needs. Mechanisms include dissolution control using matrix or encapsulation methods, diffusion control using reservoir or matrix devices, and combinations of dissolution and diffusion. Common polymers used for coatings include ethyl cellulose and acrylic resins to control drug release rate.
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During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
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- ANDA is an application to the FDA to manufacture and market a generic drug in the US that is equivalent to an approved brand name drug.
- ANDAs are abbreviated because generic drugs do not require clinical trials and provide less information than an NDA for a new drug.
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The document discusses abbreviated new drug applications (ANDAs) for generic drugs. It provides information on:
- ANDAs allow generic drugs to gain approval without duplicating clinical trials by showing bioequivalence to an approved brand name drug.
- The Hatch-Waxman Act established bioequivalence as the basis for approving generic copies and expedites the generic drug approval process.
- ANDAs must contain information on labeling, manufacturing, chemistry and quality controls to demonstrate equivalence to the branded reference drug.
Anda 2011 ppt raaj gprac
The document provides background information on the Hatch-Waxman Act, including:
- It summarizes the key people involved in creating the Act - Henry Waxman and Orrin Hatch.
- It outlines the history of drug regulation legislation leading up to the Hatch-Waxman Act of 1984.
- It describes the objectives and key features of the Hatch-Waxman Act, which established an abbreviated approval pathway for generic drugs to help increase competition and lower drug costs.
pharma regulatory a
This document provides an overview of the global generic pharmaceutical industry and the regulatory process for approving generic drugs in the United States. It discusses key topics such as:
1) The size and growth of the global generic market compared to the overall pharmaceutical industry.
2) How the Hatch-Waxman Act of 1984 streamlined the generic drug approval process in the US through the ANDA pathway.
3) Potential issues with the Hatch-Waxman Act around "evergreening" patents and deals between brand and generic companies that delay generic competition.
Swapnil2
The document provides an overview of the global pharmaceutical industry and the generic drug market. It discusses how the generic drug market is growing faster than the overall pharmaceutical industry. It also summarizes the key requirements for FDA approval of generic drugs, including bioequivalence to the branded version. Additionally, it outlines the Hatch-Waxman Act which aims to balance generic and branded drug competition in the US market.
ANDA FDA APPLICATION
The document discusses the process of drug development and approval, including the role of generic drugs. It covers the following key points:
1. There are 5 stages of drug development from discovery to post-marketing trials. Generic drugs can enter after patents and exclusivity expire through an abbreviated approval process requiring only proof of bioequivalence rather than full clinical trials.
2. The Hatch-Waxman Act of 1984 aimed to balance incentives for innovation with increased generic competition. It established provisions for patent term extensions and periods of marketing exclusivity for innovators as well as an abbreviated approval pathway for generics.
3. Generics must file an ANDA demonstrating bioequivalence to the reference drug and can
Abbreviated New Drug Application [ANDA]
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
NDA Vs ANDA
This document provides an overview of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). NDAs are required for new drugs and include extensive clinical trial data to prove safety and efficacy. The review process takes 12-15 years and is more expensive. ANDAs are for generic drugs and do not require new clinical trials, only proof of bioequivalence. The review process takes 1-2 years and is less expensive. Both application types provide information on chemistry, manufacturing, labeling, and clinical data in a standardized format.
ANDA.pptx
An Abbreviated New Drug Application (ANDA) allows generic drug manufacturers to file an application to obtain approval for a generic version of an approved drug. The ANDA contains data to demonstrate the generic drug is bioequivalent to the reference listed drug. If approved, the generic drug can provide a safe, effective, and lower-cost alternative to patients. The ANDA process helps expedite approval of generic drugs and increase competition in the pharmaceutical market.
Naresh... anda ppt
This document provides information about abbreviated new drug applications (ANDAs) and the generic drug approval process. It defines a generic drug and ANDA, outlines the basic requirements for an ANDA, and describes the evolution and key aspects of the ANDA pathway established by the Waxman-Hatch Act of 1984. This includes the requirements for bioequivalence testing and patent certifications that allow generic drugs to be approved without duplicative clinical trials. The Center for Drug Evaluation and Research (CDER) at the FDA is responsible for reviewing ANDAs to approve safe and effective generic drug products.
ANDA Filling Process
The document discusses generic drugs and the Abbreviated New Drug Application (ANDA) process. It explains that an ANDA contains data to review and approve a generic drug as a safe and effective alternative to the original brand name drug. It provides details on the Hatch-Waxman Act which established the modern generic drug approval pathway and allows generics to reference clinical data from the branded version. The document also outlines the requirements for generic drugs to be approved as well as the various certification pathways in the ANDA process.
New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)
The document summarizes the key differences between a New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA). An NDA is required for approval of new pharmaceuticals and contains extensive nonclinical and clinical data to establish safety and effectiveness. An ANDA is for generic drugs and contains bioequivalence data comparing it to an existing approved drug, but does not require new clinical trials. The review process is shorter for ANDAs compared to NDAs. The document also discusses patent certification requirements for ANDAs and exclusivity periods for orphan drugs.
Global Submission ANDA.pptx
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
To reduce the price of the drug. To reduce the time development. Increase the bioavailability of the drug in comparison to reference list drug.
Global Submission ANDA-.pdf
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
Global Submission ANDA.pptx
An ‘Abbreviated New Drug Application (ANDA)’ is an application for a U.S. generic drug approval from FDA under section 505(j) for an existing licensed medication or approved drug. A generic drug product is one that is comparable to a patented drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
Hatch-Waxman Act Using bioequivalence as the basis for approving generic copies of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) , also known as the Hatch-Waxman Act.
The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, established the modern system of government generic drug regulation in the United States under section 505(j) of the FD&C Act.
The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research.
GDUFA10 was signed into law to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry.
Office of generic drug (OGD) strongly encourages submission of bioequivalence, chemistry and labeling portions of the application in electronic format.
This guidance details the information that should be provided in each section of the common technical document (CTD) format for human pharmaceutical product applications2 and identifies supporting guidance documents and recommendations issued by FDA to assist applicants in preparing their ANDA submission.
Generic drug ppt
The document discusses the generic drug development process and the Hatch-Waxman Act. It defines generic drugs as being identical to brand name drugs in active ingredients, dosage form, quality and therapeutic effects. The generic drug approval process involves submitting an Abbreviated New Drug Application to the FDA that demonstrates bioequivalence to the brand name drug. The Hatch-Waxman Act established the modern system of generic drug regulation, providing incentives for generic drugs to gain FDA approval and compensating brand name drugs for patent time lost during regulatory review.
Abbrevated New Drug Applications- Basics
The document discusses Abbreviated New Drug Applications (ANDAs), which are applications for generic drug approval submitted to the FDA. Key points:
- ANDAs are used to gain approval for generic versions of off-patent drugs without requiring costly preclinical and clinical testing, as long as they are proven to be bioequivalent to the branded version.
- The Hatch-Waxman Act of 1984 established the modern ANDA pathway, allowing generics to reference pioneer drug data and challenging patents to bring cheaper drugs to market sooner.
- ANDAs must demonstrate the generic drug is identical to the branded reference drug in active ingredients, strength, dosage form, route of administration, quality and labeling. Bioequival
Global submission of abbreviated new drug application (
An abbreviated new drug application (ANDA) contains data submitted to regulatory agencies like the FDA for approval of generic drug products. ANDAs are abbreviated because generic drugs do not require new clinical trials, but must demonstrate bioequivalence to the branded reference drug. The Hatch-Waxman Act established bioequivalence standards and created provisions encouraging generic drug development. ANDAs include information on manufacturing, labeling, and patent certifications. Regulatory review of ANDAs evaluates bioequivalence data and facility inspections to determine approval of generic drugs in the US, Europe, and India.
Abriviated new drug application 505(j) filling
An abbreviated new drug application (ANDA) allows generic drug manufacturers to file for FDA approval of a generic drug. The ANDA relies on the safety and efficacy data of an approved innovator drug and must demonstrate bioequivalence through bioavailability/bioequivalence studies. There are different types of ANDA applications including Paragraph I, II, III, and IV, with Paragraph IV applications being used when a generic applicant is attempting to enter the market before patent expiration by claiming the patents are invalid or would not be infringed by the generic product. The ANDA review process involves a 30 month stay if the innovator sues for patent infringement within 45 days, during which time the first approved generic receives 180 days of market
Regulatory Affairs Interview Questions .pdf
This document provides definitions and explanations of key concepts and terms related to regulatory affairs in the pharmaceutical industry. It defines regulatory affairs as the interface between the pharmaceutical industry and drug regulatory authorities, and describes their main roles as ensuring safety, efficacy and quality of drugs; ensuring appropriate product information; and acting as a liaison with regulatory agencies in submissions and ensuring compliance. It goes on to define various application types such as NDA, ANDA, IND, MAA, DMF and ASMF. It also covers regulatory guidelines, agencies and procedures.
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New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)
New Drug Application(Nda) Vs Abbreviated New Drug Application (Anda)
Global submission of abbreviated new drug application (
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Anda.ppt
- 1. ANDA for generic drug ways & means of US registration for foreign drug Submitted by: Submitted to : Sishant Rav Divya Dr. Hafsa Ahmad M.Pharm First Year ( Pharmaceutics ) BBAU Lucknow 1
- 2. Contents Introduction Basic generic drug requirement Objective of ANDA Innovator Vs. Generic Comparson between NDA & ANDA Generic drug approval Hatch-Waxman act 1984 General provision of this act Broad outline for ANDA Information required for filing ANDA Patent Certification The Orange Book Review of ANDA References 2
- 3. DEFINITION of 'Abbreviated New Drug Application (ANDA)' A written request to the U.S. Food and Drug Administration (FDA’s CDER) office of generic drug, to manufacture and market a generic drug in the United States. Abbreviated New Drug Applications are “abbreviated” since they do not require the applicant to conduct clinical trials and require less information than a New Drug Application. If an ANDA is approved, the generic drug will be listed in the Orange Book, which lists all medicines the FDA has found to be safe and effective. 3
- 4. Basic Generic Drug Requirements Are Same active ingredient Same route of administration Same dosage form Same strength Same condition for uses Inactive ingredient already approved in similar NDA 4
- 5. Main objective of ANDA To reduce the price of drug. To reduce the time development. To increase the bioavailability. 5
- 6. Innovator & Generic S.N. Parameters Innovator (Brand ) Generic (Chemical ) 1 Active ingredient Same Same 2 Safety & Efficacy Same Same 3 Performance/standar ds Same Same 4 Cost More expensive Less Expensive 5 FDA inspection of manufacturing process Yes Yes 6 FDA received report of adverse reaction Yes Yes 7 FDA received drug labelling Yes Yes 6
- 7. Comparison between NDA and ANDA S.No. NDA ANDA 1 Application for New drug Application for Generic Drug 2 Take long time ( 12-15 Yrs. ) Take less time ( 1-2 Yrs. ) 3 More Expenditure of money Comparatively less 4 Cost of drug more Cost of drug less 5 Non-clinical & clinical study are essential Both are not essential 6 Bioavailability & Bioequivalence studies are essential Only Bioequivalence study essential 7
- 8. Generic Drug Approval In 1970 FDA established the ANDA For review and approval of generic version. Before 1978 generic product applicant were required to submit the complete safety & efficacy through Clinical Trial. Post 1978 generic product applicant were required to published report of such trial 8
- 9. Hatch-Waxman Act 1984 Hatch-Waxman commonly known as “Drug Price Completion & Patent Term restoration Act 1984 This act dealing with approval of Generic drug 9
- 10. General provision of the act Maintaining list of patent Only bioequivalence study required No need clinical trial Para-I,II,III and IV certification Bolar Provision Data exclusive period for new molecule entities Extension of the original patent term 10
- 11. Broad outline for ANDA Product must meet appropriate standards of Identity. Strength. Quality and Purity Efficacy and safety should be equivalent to brand product already established 11
- 12. Information required for filing ANDA Product’s formulation Manufacturer’s procedure Control procedure Testing Facilities Dissolution profile Labelling 12
- 13. Patent Certification While filling an ANDA, the generic manufacturer is required to one of the following four certification The subject of the reference brand name listed in the ORANGE BOOK 13
- 14. Certification Para I certificate: There is no patent for the drug listed in the orange book Para II certificate: Patent is listed but expired Para III certification : Patent is listed . Is valid but the generic wants approval to market the drug once the pertinent patent expires 14
- 15. Certification Para IV certificate: Is the most critical of all and gives to almost all the anti-competitive practices associated with the Hatch-Waxman amendments of the EED and C act 15
- 16. The Orange Book The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information. For more information on the Orange Book including its history, 16
- 18. 18
- 20. 20