{"id":3008,"date":"2022-11-30T18:46:37","date_gmt":"2022-11-30T13:16:37","guid":{"rendered":"https:\/\/pharmaceuticalcarrier.com\/?p=3008"},"modified":"2022-11-30T21:19:16","modified_gmt":"2022-11-30T15:49:16","slug":"regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry","status":"publish","type":"post","link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/","title":{"rendered":"Top 25 Regulatory Affairs (RA) Interview Questions in Pharmaceutical Industry"},"content":{"rendered":"\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-transparent ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_Regulatory_Affairs\" >What is Regulatory Affairs?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_are_the_goals_of_Regulatory_Affairs_Professionals\" >What are the goals of Regulatory Affairs Professionals?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_are_the_Roles_of_Regulatory_Affairs_professionals\" >What are the Roles of Regulatory Affairs professionals?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_an_Investigational_New_Drug_IND_application\" >What is an Investigational New Drug (IND) application?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_a_New_Drug_Application\" >What is a New Drug Application?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_an_Abbreviated_New_Drug_Application_ANDA\" >What is an Abbreviated New Drug Application (ANDA)?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_a_Generic_Drug_Product\" >What is a Generic Drug Product?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_a_DMF\" >What is a DMF?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#Important_facts_regarding_DMFs\" >Important facts regarding DMFs<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#_What_are_the_types_of_DMFs\" >&nbsp;What are the types of DMF\u2019s?<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_a_505_b2_application\" >What is a 505 (b)(2) application ?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_kind_of_application_can_be_submitted_as_a_505b2_application\" >What kind of application can be submitted as a 505(b)(2) application?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_are_the_examples_of_changes_to_approved_drug_products_for_which_505b2_application_should_be_submitted\" >What are the examples of changes to approved drug products for which 505(b)(2) application should be submitted ?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_are_the_chemical_classification_codes_for_NDA\" >What are the chemical classification codes for NDA?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_are_the_differences_between_NDA_and_505_b2_application\" >What are the differences between NDA and 505 (b)(2) application ? &nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_a_Marketing_Authorization_Application\" >What is a Marketing Authorization Application?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_an_ASMF\" >What is an ASMF?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_are_the_types_of_active_substances_for_which_ASMFs_are_submitted\" >What are the types of active substances for which ASMFs are submitted?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_the_difference_between_DMF_and_ASMF_with_respect_to_submission\" >What is the difference between DMF and ASMF (with respect to submission)?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_ICH\" >What is ICH?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_CTD\" >What is CTD?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_are_the_modules_in_CTD\" >What are the modules in CTD?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-23\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_Orange_Book\" >What is Orange Book?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-24\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_Hatch-Waxman_act\" >What is Hatch-Waxman act?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-25\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_are_the_patent_certifications_under_Hatch-Waxman_act\" >What are the patent certifications under Hatch-Waxman act?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-26\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_is_meant_by_180_day_exclusivity\" >What is meant by 180 day exclusivity?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-27\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/#What_are_the_procedures_for_Approval_of_Drug_in_EU\" >What are the procedures for Approval of Drug in EU?<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_Regulatory_Affairs\"><\/span><strong><em>What is Regulatory Affairs?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Regulatory Affairs in the pharmaceutical industry, is a profession that acts as the interface between the pharmaceutical industry and drug regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing.<\/p><div class=\"pharm-content\" id=\"pharm-962235799\"><script async src=\"\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-8402705006112223\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display:block;\" data-ad-client=\"ca-pub-8402705006112223\" \ndata-ad-slot=\"7652789694\" \ndata-ad-format=\"auto\"><\/ins>\n<script> \n(adsbygoogle = window.adsbygoogle || []).push({}); \n<\/script>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_goals_of_Regulatory_Affairs_Professionals\"><\/span><strong><em>What are the goals of Regulatory Affairs Professionals?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Protection of human health<\/li><li>Ensuring safety, efficacy and quality of drugs<\/li><li>Ensuring appropriateness and accuracy of product information<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_Roles_of_Regulatory_Affairs_professionals\"><\/span><strong><em>What are the Roles of Regulatory Affairs professionals?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Act as a liaison with regulatory agencies<\/li><li>Preparation of organized and scientifically valid NDA, ANDA,INDA ,MAA,DMF submissions<\/li><li>Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws<\/li><li>Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans<\/li><li>Advising the companies on regulatory aspects and climate that would affect their proposed activities<\/li><li>Apart from the above main roles, there are various other roles which Regulatory Affairs professionals play.<\/li><\/ul>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-5fc247b4\"><h2 class=\"uagb-heading-text\"><span class=\"ez-toc-section\" id=\"What_is_an_Investigational_New_Drug_IND_application\"><\/span><strong><em>What is an Investigational New Drug (IND) application?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2><\/div>\n\n\n\n<p>It is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA<\/p>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-d3591bae\"><h2 class=\"uagb-heading-text\"><span class=\"ez-toc-section\" id=\"What_is_a_New_Drug_Application\"><\/span><strong><em>What is a New Drug Application?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2><\/div>\n\n\n\n<p>The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.&nbsp; The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDA<\/p>\n\n\n\n<p>In simple words, \u201cIt is an application which is filed with FDA to market a new Pharmaceutical for sale in USA\u201d<\/p>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-bf90ce48\"><h2 class=\"uagb-heading-text\"><span class=\"ez-toc-section\" id=\"What_is_an_Abbreviated_New_Drug_Application_ANDA\"><\/span><strong><em>What is an Abbreviated New Drug Application (ANDA)?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2><\/div>\n\n\n\n<p>It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug.<\/p>\n\n\n\n<p>In simple words, \u201cIt is an application for the approval of Generic Drugs \u201c<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_a_Generic_Drug_Product\"><\/span><strong><em>What is a Generic Drug Product?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A generic drug product is the one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.&nbsp;&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-baa644eb\"><h2 class=\"uagb-heading-text\"><span class=\"ez-toc-section\" id=\"What_is_a_DMF\"><\/span><strong><em>What is a DMF?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2><\/div>\n\n\n\n<p>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.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Important_facts_regarding_DMFs\"><\/span><strong><em>Important facts regarding DMFs<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li>It is submitted to FDA to provide confidential information<\/li><li>Its submission is not required by law or regulations<\/li><li>It is neither approved nor disapproved<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these<\/li><li>It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420<\/li><li>It is not required when applicant references its own information<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"_What_are_the_types_of_DMFs\"><\/span>&nbsp;<strong><em>What are the types of DMF\u2019s?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><strong><em>Type I:<\/em><\/strong>Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA)<\/p>\n\n\n\n<p><strong><em>Type II: <\/em><\/strong>Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product<\/p>\n\n\n\n<p><strong><em>Type III: <\/em><\/strong>Packaging Material<\/p>\n\n\n\n<p><strong><em>Type IV :<\/em> <\/strong>Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation <strong><em>Type V:<\/em><\/strong> FDA Accepted Reference Information (FDA discourages its use)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_a_505_b2_application\"><\/span><strong><em>What is a 505 (b)(2) application ?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>505 (b)(2) application is a type of NDA for which one or more investigations relied on by applicant for approval were not conducted by\/for applicant and for which applicant has not obtained a right of reference.<\/p>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-c0bf7209\"><h2 class=\"uagb-heading-text\"><span class=\"ez-toc-section\" id=\"What_kind_of_application_can_be_submitted_as_a_505b2_application\"><\/span><strong><em>What kind of application can be submitted as a 505(b)(2) application?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2><\/div>\n\n\n\n<ul class=\"wp-block-list\"><li>New chemical entity (NCE)\/new molecular entity (NME)<\/li><li>Changes to previously approved drugs<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_examples_of_changes_to_approved_drug_products_for_which_505b2_application_should_be_submitted\"><\/span><strong><em>What are the examples of changes to approved drug products for which 505(b)(2) application should be submitted ?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Change in dosage form.<\/li><li>Change in strength<\/li><li>Change in route of administration<\/li><li>Substitution of an active ingredient in a formulation product<\/li><li>Change in formulation<\/li><li>Change in dosing regimen<\/li><li>Change in active ingredient<\/li><li>New combination Product<\/li><li>New indication<\/li><li>Change from prescription indication to OTC indication<\/li><li>Naturally derived or recombinant active ingredient<\/li><li>Bioinequivalence<\/li><\/ul>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-93b62c33\"><h2 class=\"uagb-heading-text\"><span class=\"ez-toc-section\" id=\"What_are_the_chemical_classification_codes_for_NDA\"><\/span><strong><em>What are the chemical classification codes for NDA?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2><\/div>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>Number<\/strong><\/td><td><strong>Meaning<\/strong><\/td><\/tr><tr><td>1<\/td><td>New molecular entity (NME)<\/td><\/tr><tr><td>2<\/td><td>New ester, new salt, or other noncovalent derivative<\/td><\/tr><tr><td>3<\/td><td>New formulation<\/td><\/tr><tr><td>4<\/td><td>New combination<\/td><\/tr><tr><td>5<\/td><td>New manufacturer<\/td><\/tr><tr><td>6<\/td><td>New indication<\/td><\/tr><tr><td>7<\/td><td>Drug already marketed, but without an approved NDA<\/td><\/tr><tr><td>8<\/td><td>OTC (over-the-counter) switch<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-47c6e785\"><h2 class=\"uagb-heading-text\"><span class=\"ez-toc-section\" id=\"What_are_the_differences_between_NDA_and_505_b2_application\"><\/span><strong><em>What are the differences between NDA and 505 (b)(2) application ?<\/em><\/strong> &nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2><\/div>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>S.No.<\/strong><\/td><td><strong>New Drug Application (NDA)<\/strong><\/td><td><strong>505 (b)(2) Application<\/strong><\/td><\/tr><tr><td>1.<\/td><td>All investigations relied on by applicant for approval were conducted by\/for applicant and for which applicant has right of reference<\/td><td>One or more investigation relied on by applicant for approval were not conducted by\/for applicant and for which applicant has not obtained a right of reference<\/td><\/tr><tr><td>2.<\/td><td>Generally, filed for newly invented pharmaceuticals.<\/td><td>Generally, filed for new dosage form, new route of administration, new indication etc for all already approved pharmaceutical.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong><em>Note: <\/em><\/strong>505 (b)(2) application is a type of NDA.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_a_Marketing_Authorization_Application\"><\/span><strong><em>What is a Marketing Authorization Application?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Ans-<\/strong> It is an application filed with the relevant authority in the Europe (typically, the UK&#8217;s MHRA or the EMA\u2019s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine.<\/p>\n\n\n\n<p>As per the UK\u2019s MHRA:<\/p>\n\n\n\n<p>Applications for new active substances are described as &#8216;full applications&#8217;.<\/p>\n\n\n\n<p>Applications for medicines containing existing active substances are described as &#8216;abbreviated\u2019 or \u2018abridged applications\u2019.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_an_ASMF\"><\/span><strong><em>What is an ASMF?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong><em>Ans-<\/em><\/strong>Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or &#8216;know-how&#8217; of the manufacturer of the active substance.<\/p>\n\n\n\n<p>In simple words, \u201cIt is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical Ingredient<\/p>\n\n\n\n<p>(API)\u201d.&nbsp;<\/p>\n\n\n\n<h2><span class=\"ez-toc-section\" id=\"What_are_the_types_of_active_substances_for_which_ASMFs_are_submitted\"><\/span><strong><em>What are the types of active substances for which ASMFs are submitted?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>New active substances<\/li><li>Existing active substances not included in the European Pharmacopoeia (Ph.<\/li><\/ul>\n\n\n\n<p>Eur.) or the pharmacopoeia of an EU Member State<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Pharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_the_difference_between_DMF_and_ASMF_with_respect_to_submission\"><\/span><strong>What<em> is the difference between DMF and ASMF (with respect to submission)?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>ASMF is submitted as Applicant\u2019s Part (Open Part) and Restricted Part (Closed Part)<\/p>\n\n\n\n<p>There isn\u2019t any differentiation of DMF\u2019s into parts<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_ICH\"><\/span><strong>What is ICH?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Ans-<\/strong>International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.<\/p>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-e184fe93\"><h2 class=\"uagb-heading-text\"><span class=\"ez-toc-section\" id=\"What_is_CTD\"><\/span><strong><em>What is CTD?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2><\/div>\n\n\n\n<p><strong>Ans-<\/strong>The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).<\/p>\n\n\n\n<p>CTD format for submission of drug registration applications\/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.&nbsp;<\/p>\n\n\n\n<p><strong><em>What are the ICH guidelines to be referred to<\/em><\/strong><strong><em> preparation of registration dossiers\/applications of medicines (with respect to format and contents in each module)?<\/em><\/strong><\/p>\n\n\n\n<p>M4&nbsp;&nbsp; Guideline&nbsp;<\/p>\n\n\n\n<p>M4Q Guideline<\/p>\n\n\n\n<p>M4S Guideline<\/p>\n\n\n\n<p>M4E Guideline<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_modules_in_CTD\"><\/span><strong><em>What are the modules in CTD?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Common Technical Document is divided into five modules:<\/p>\n\n\n\n<p>Module 1. Administrative information and prescribing information<\/p>\n\n\n\n<p>Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5)<\/p>\n\n\n\n<p>Module 3. Quality&nbsp;<\/p>\n\n\n\n<p>Module 4. Nonclinical Study Reports (toxicology studies)<\/p>\n\n\n\n<p>Module 5. Clinical Study Reports (clinical studies)<\/p>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-eece9cef\"><h2 class=\"uagb-heading-text\"><span class=\"ez-toc-section\" id=\"What_is_Orange_Book\"><\/span><strong><em>What is Orange Book?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2><\/div>\n\n\n\n<ul class=\"wp-block-list\"><li>It is the commonly used name for the book \u201c<strong>Approved Drug Products with Therapeutic Equivalence Evaluations<\/strong>\u201d, which is published by USFDA.<\/li><li>It contains the list of 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.<\/li><\/ul>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-46b3bf63\"><h2 class=\"uagb-heading-text\"><span class=\"ez-toc-section\" id=\"What_is_Hatch-Waxman_act\"><\/span><strong><em>What is Hatch-Waxman act?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2><\/div>\n\n\n\n<p><strong>Ans-<\/strong>It is the popular name for <strong>Drug Price Competition and Patent Term Restoration Act, 1984<\/strong>. It is considered as the landmark legislation which established the modern system of generic drugs in USA. Hatch-Waxman amendment of the federal food, drug and cosmetics act established the process by which, would be marketers of generic drugs can file Abbreviated New Drug Application (ANDA) to seek FDA approval of generic drugs. Paragraph IV of the act, allows 180 day exclusivity to companies that are the &#8220;first-to-file&#8221; an ANDA against holders of patents for branded counterparts.<\/p>\n\n\n\n<p>In simple words \u201cHatch-Waxman act is the amendment to Federal, Food, Drug and<\/p>\n\n\n\n<p>Cosmetics act which established the modern system of approval of generics \u201d<\/p>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-ddeecac7\"><h2 class=\"uagb-heading-text\"><span class=\"ez-toc-section\" id=\"What_are_the_patent_certifications_under_Hatch-Waxman_act\"><\/span><strong>What are the patent certifications under Hatch-Waxman act?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2><\/div>\n\n\n\n<p><strong>Ans-<\/strong>As per the Hatch and Waxman act, generic drug and 505 (b) (2) applicants should include certifications in their applications for each patent listed in the \u201cOrange Book\u201d for the innovator drug. This certification must state one of the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>that the required patent information relating to such patent has not been filed (Para I certification);<\/li><li>that such patent has expired (Para II certification);<\/li><li>that the patent will expire on a particular date (Para III certification); or<\/li><li>that such patent is invalid or will not be infringed by the drug, for which approval is being sought(Para IV certification).<\/li><\/ul>\n\n\n\n<p>A certification under paragraph I or II permits the ANDA to be approved immediately, if it is otherwise eligible. A certification under paragraph III indicates that the ANDA may be approved when the patent expires.<\/p>\n\n\n\n<h2><span class=\"ez-toc-section\" id=\"What_is_meant_by_180_day_exclusivity\"><\/span><strong><em>What is meant by 180 day exclusivity?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Ans-<\/strong>The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the \u201cfirst\u201d generic applicant who challenges a listed patent by filing a paragraph IV certification and thereby runs the risk of having to defend a patent infringement suit.<\/p>\n\n\n\n<p>180 Day Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of&nbsp; Lipitor ( Atorvastatin calcium).<\/p>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-f824191f\"><h2 class=\"uagb-heading-text\"><span class=\"ez-toc-section\" id=\"What_are_the_procedures_for_Approval_of_Drug_in_EU\"><\/span><strong><em>What are the procedures for Approval of Drug in EU?<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2><\/div>\n\n\n\n<p>Centralised Procedure (CP)<\/p>\n\n\n\n<p>Decentralised Procedure (DCP)<\/p>\n\n\n\n<p>Mutual Recognition Procedure (MRP)<\/p>\n\n\n\n<p>National Procedure (NP)<\/p>\n\n\n\n<p>For more articles on regulatory guidance follow below link<\/p>\n\n\n\n<p><a href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/latest-articles\/\">Click here<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>What is Regulatory Affairs? Regulatory Affairs in the pharmaceutical industry, is a profession that acts as the interface between the pharmaceutical industry and drug regulatory authorities across the world. It is mainly involved in the registration of the drug products<\/p>\n<p><a href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/2022\/11\/30\/regulatory-affairs-ra-interview-questions-in-pharmaceutical-industry\/\" class=\"blog-read-more\">Read More<\/a><\/p>\n","protected":false},"author":1,"featured_media":3013,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","footnotes":""},"categories":[32],"tags":[152,31,153,149,9,150,154],"class_list":["post-3008","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-guidance","tag-dra","tag-fda-guidance","tag-pharma-interview","tag-pharmaceutical-regulatory-affairs","tag-pharmaceuticals","tag-ra","tag-top-25-questions"],"uagb_featured_image_src":{"full":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2022\/11\/RA-image.jpg",1920,1080,false],"thumbnail":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2022\/11\/RA-image-150x150.jpg",150,150,true],"medium":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2022\/11\/RA-image-300x169.jpg",300,169,true],"medium_large":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2022\/11\/RA-image-768x432.jpg",640,360,true],"large":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2022\/11\/RA-image-1024x576.jpg",640,360,true],"1536x1536":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2022\/11\/RA-image-1536x864.jpg",1536,864,true],"2048x2048":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2022\/11\/RA-image.jpg",1920,1080,false],"authorship-box-avatar":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2022\/11\/RA-image-150x150.jpg",150,150,true],"authorship-box-related":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2022\/11\/RA-image-70x70.jpg",70,70,true],"sow-carousel-default":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2022\/11\/RA-image-272x182.jpg",272,182,true]},"uagb_author_info":{"display_name":"Tanaji Janwale","author_link":"#molongui-disabled-link"},"uagb_comment_info":66,"uagb_excerpt":"What is Regulatory Affairs? Regulatory Affairs in the pharmaceutical industry, is a profession that acts as the interface between the pharmaceutical industry and drug regulatory authorities across the world. It is mainly involved in the registration of the drug productsRead More","amp_enabled":true,"_links":{"self":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts\/3008","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/comments?post=3008"}],"version-history":[{"count":5,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts\/3008\/revisions"}],"predecessor-version":[{"id":3017,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/posts\/3008\/revisions\/3017"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/media\/3013"}],"wp:attachment":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/media?parent=3008"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/categories?post=3008"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/tags?post=3008"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}