Regulatory Affairs:- Regulatory Affairs in a Pharmaceutical industry, is a profession which 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.
Goals Of Regulatory Affairs Professionals:- Protection of human health ensuring safety, efficacy and quality of drugs ensuring appropriateness and accuracy of product information
Roles Of Regulatory Affairs Professionals:-  Act as a liaison with regulatory agencies, preparation of organised and scientifically valid NDA, ANDA,INDA,MAA,DMF submission ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans advising the companies on regulatory aspects and climate that would affect their proposed activities.
Investigational New Drug (IND) Application:- It is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA
New Drug Application(NDA):-  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. The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDA. In simple words, “It is an application which is filed with FDA to market a new Pharmaceutical for sale in USA”
Abbreviated New Drug Application (ANDA):-  It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug. In simple words, “It is an application for the approval of Generic Drugs “
Generic Drug Product:- 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.
Drug Master File (DMF):- It is submitted 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 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 applicant references its own information.

Types Of DMF’s:-

  • 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, Flavour, Essence, or Material Used in Their Preparation.
  • Type V: FDA Accepted Reference Information (FDA discourages its use)

505 (b)(2) Application:- 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.
Marketing Authorisation Application:- It is an application filed with the relevant authority in the 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 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’.
Active Substance Master File (ASMF):- It 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)”.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH):- It 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.
Common Technical Document (CTD):- It 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.
Modules In CTD:- 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)
Orange Book:- It is the commonly used name for the book “Approved Drug Products  Equivalence Evaluations”, which is published by USFDA. 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.
Hatch-Waxman Act:- It is the popular name for Drug Price Competition and Patent Term Restoration Act, 1984. 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 “first-to-file” an ANDA against holders of patents for branded counterparts. In simple words “Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics ”.
Patent Certifications Under Hatch-Waxman Act:- 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 “Orange Book” for the innovator drug. This certification must state one of the following:

  • that the required patent information relating to such patent has not been filed (Para I certification).
  • that such patent has expired (Para II certification).
  • that the patent will expire on a particular date (Para III certification).
  • that such patent is invalid or will not be infringed by the drug, for which approval is being sought (Para IV certification). 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.

180 Day Exclusivity:- 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).
Procedures For Approval Of Drug In EU:-
Centralised Procedure (CP)y
Decentralised Procedure (DCP)
Mutual Recognition Procedure (MRP)
National Procedure (NP)
Certificate Of Suitability To The Monographs Of The European Pharmacopoeia        (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.
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