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Goals of RA
- Protection of human health
- Ensuring safety, efficacy and quality of drugs
- Ensuring appropriateness and accuracy of product information
Call Us : +91 888 690 4030Email : info@cliniindia.com
Call Us : +91 888 690 4030Email : info@cliniindia.com
Career domainPharma regulatory · Submissions
Pharma regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry.
34Interview Q&As
7Product areas
FDA · EMAUS & EU submissions
CDSCOIndia’s regulator
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Regulatory affairs
The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance, are all considered regulatory professionals.
Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:
Goals & roles
Regulatory affairs acts as the interface between the pharmaceutical industry and drug regulatory authorities across the world.
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Interview questions
34 questions in four groups — pick a group, then open a question to see the answer.
01
8 questions
02
12 questions
03
7 questions
04
7 questions
8 questions
The profession, its goals and where it fits
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.
The main goals of RA are:
The main roles of RA professionals:
They must be detail oriented and able to develop realistic action plans as well as prioritizing work activities – without these there are bound to be difficulties in keeping up with all the tasks.
Regulatory submission is the process through which pharmaceutical companies submit the information about their newly developed healthcare product to a regulatory agency for review. They can also submit their documentation seeking additional knowledge about their device.
The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves a parallel function to the European Medicines Agency of the European Union, the PMDA of Japan and the Food and Drug Administration of the United States.
The United States (US) and the EU are the biggest and the most potential markets in the world and are categorized under the regulated markets, whereas the ROW (Rest of the World) market includes all the emerging markets like Brazil (LATAM), Tanzania (Africa), Russia (CIS), Hong Kong (Asia), etc.
Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) is a specific area within RA that has the ultimate responsibility for providing CMC regulatory leadership and strategy required to achieve regulatory approvals.
12 questions
IND, NDA, ANDA, 505(b)(2), DMF and eCTD
It’s an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA.
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 the USA.
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.
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.
A 505(b)(2) application is a type of NDA for which one or more investigations relied on by the applicant for approval were not conducted by/for the applicant and for which the applicant has not obtained a right of reference.
| New Drug Application (NDA) | 505(b)(2) application |
|---|---|
| All investigations relied on by the applicant for approval were conducted by/for the applicant, and the applicant has a right of reference. | One or more investigations relied on by the applicant for approval were not conducted by/for the applicant, and the applicant has not obtained a right of reference. |
| Generally filed for newly invented pharmaceuticals. | Generally filed for a new dosage form, new route of administration, new indication etc. for already approved pharmaceuticals. |
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:
The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).
7 questions
MAA, ASMF, approval procedures and CEP
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:
An Active Substance Master File (ASMF) 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 the active substance or Active Pharmaceutical Ingredient (API).
An ASMF is submitted as the Applicant’s Part (Open Part) and the Restricted Part (Closed Part). There isn’t any differentiation of DMFs into parts.
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).
It is the certificate which is issued by the Certification of Substances Division of the 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.
7 questions
Harmonised formats for registration dossiers
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.
With respect to format and contents in each module:
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicines, designed to be used across Europe, Japan and the United States. Quality, safety and efficacy information is assembled in a common format through the CTD. The CTD is maintained by the International Council for Harmonisation (ICH).
The CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too, like Canada, Australia etc.
The Common Technical Document is divided into five modules:
The ACTD consists of Parts I to IV which have subsections A to F, whereas the ICH-CTD has 5 modules with subsections that are numbered. The administrative data of Part I is part of the ACTD, whereas Module 1 of the ICH-CTD is purely country specific.
A regulatory dossier means all regulatory documents and filings registered with a drug regulatory authority for a marketing authorisation, containing the administrative, safety, efficacy, quality, non-clinical and clinical data and CMC data for the drug product as it may change from time to time.
A dossier is a collection of documents on a particular subject. Any preparation of a pharmaceutical product for human use goes through the process of reviewing and assessing the dossier of the pharmaceutical product, which contains detailed information about administrative, quality, non-clinical and clinical data.
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