What is a DMF?
Ans- 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.
Important facts regarding DMFs
It is submitted to the FDA to provide confidential information. Its submission is not required by law or regulations. It is neither approved nor disapproved
It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these. It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420. It is not required when the applicant references its own information.
Important facts regarding DMFs
It is submitted to the FDA to provide confidential information. Its submission is not required by law or regulations. It is neither approved nor disapproved
It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these. It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420. It is not required when the applicant references its own information.
What are the types of DMF’s?
Ans-
Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA)
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 (FDA discourages its use)
What is a Marketing Authorization Application?
Ans- It is an application filed with the relevant authority in Europe (typically, the UK’s MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine.
As per the UK’s MHRA-
Applications for new active substances are described as ‘full applications’.
Applications for medicines containing existing active substances are described as ‘abbreviated’ or ‘abridged applications’.
What is an ASMF?
Ans-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 ‘know-how’ of the manufacturer of the active substance.
In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical Ingredient (API)”.
What are the types of active substances for which ASMFs are submitted?
Ans-
New active substances. Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member StatePharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State.
What is the difference between DMF and ASMF (with respect to submission)?
Ans-ASMF is submitted as Applicant’s Part (Open Part) and Restricted Part (Closed Part)
There isn’t any differentiation of DMF’s into parts
What is meant by 180-day exclusivity?
Ans-The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the “first” 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.
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 Lipitor ( Atorvastatin calcium).
What is the Full form of abbreviation, CEP?
Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs. It is also informally referred to as Certificate of Suitability (COS).
What is CEP?
It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.
What is CTD?
Ans-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).
CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.
What is ICH?
Ans-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
What are the ICH guidelines to be referred for preparation of registration dossiers/applications of medicines (With respect to format and contents in each module)?
Ans-
- M4 Guideline
- M4Q Guideline
- M4S Guideline
- M4E Guideline
What are the modules in CTD?
Ans-
The Common Technical Document is divided into five modules:
Module 1. Administrative information and prescribing information
Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5)
Module 3. Quality
Module 4. Nonclinical Study Reports (toxicology studies)
Module 5. Clinical Study Reports (clinical studies)
What is a 505 (b)(2) application?
Ans- 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 the applicant and for which applicant has not obtained a right of reference.
What kind of application can be submitted as a 505(b)(2) application?
Ans-
New chemical entity (NCE)/new molecular entity (NME)Changes to previously approved drugs.
What are the examples of changes to approved drug products for which 505(b)(2) application should be submitted?
Ans-
Change in the dosage form. Change in strength Change in the route of administration Substitution of an active ingredient in a formulation product Change in formulation Change in dosing regimen Change in active ingredient New combination Product New indication Change from prescription indication to OTC indication Naturally derived or recombinant active
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