Regulatory Affairs – Interview Questions
What is 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.
What Are The Goals Of Regulatory Affairs (RA) Professionals?
The main goal of RA
- Protection of human health
- Ensuring safety, efficacy and quality of drugs
- Ensuring appropriateness and accuracy of product information.
What Are The Roles Of Regulatory Affairs Professionals?
The main role of RA Professionals:
- Act as a liaison with regulatory agencies.
- Preparation of organized and scientifically valid NDA, ANDA, INDA, MAA, DMF submissions.
- 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.
- Apart from the above main roles, there are various other roles which Regulatory Affairs professionals play.
- Keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products.
- Advising on legal and scientific restraints and requirements.
- Collecting, collating and evaluating scientific data.
- Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorisation for the products concerned.
- Giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole.
- Helping the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data.
What is an investigational: New Drug (ind) Application?
It‘s application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA.
What is a 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.
What Are The Chemical Classification Codes For NDA?
- New molecular entity (NME)
- New ester, new salt, or other non-covalent derivative
- New formulation
- New combination
- New manufacturer
- New indication
- Drug already marketed, but without an approved NDA
- OTC (over-the-counter) switch
What Is An 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 ―
What Is A 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.
What Is A DMF?
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 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.
What Are the 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)
What is A 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.
What Kind Of Application Can Be Submitted As A 505(b)(2) Application?
- 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 ?
Change in dosage form.
- Change in strength.
- Change in 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 ingredient.
- Bioinequivalence.
What Is A Marketing Authorization Application (MAA)?
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‘.
What Is An ASMF?
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 Active Substance or Active pharmaceutical Ingredient (API)‖.
What Are The Types Of Active Substances For Which ASMFS Are Submitted?
- New active substances
- Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member State
- Pharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State
What Is The Difference Between DMF & ASMF (with Respect To Submission)?
ASMF is submitted as Applicant‘s Part (Open Part) and Restricted Part (Closed Part). There isn‘t any differentiation of DMF‘s into parts
DMF
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.
ASMF
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 Active Substance or Active pharmaceutical Ingredient (API)‖.
What Is ICH?
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 Active Substance or Active pharmaceutical Ingredient (API)‖.
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)?
- M4 Guideline
- M4Q Guideline
- M4S Guideline
- M4E Guideline
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 Harmonization 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 Are The 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)
What Are The Procedures For Approval Of Drug In EU?
- Centralised Procedure (CP)
- Decentralised Procedure (DCP)
- Mutual Recognition Procedure (MRP)
- National Procedure (NP)
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 A 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 dossier in regulatory affairs?
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.
What are medical device regulatory affairs?
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies.
What does regulatory framework mean?
Regulatory Framework means any laws, regulations, decrees and policies officially developed and approved by the government, for the purposes of regulating SOLID WASTE generation, collection, transport, recycling, reuse, treatment and disposal.
What is a regulatory process?
The Regulatory Process. What is a regulation? Regulations, or rules, are a primary vehicle with which agencies implement specific laws and general agency objectives. They are specific standards or instructions concerning what can or cannot be done by individuals, businesses, and other organizations.
What are regulatory standards?
Definition of Regulatory Standards: Regulatory Standards means all laws, rules, regulations and Regulatory Authority advisory opinions or orders applicable to the manufacturing, marketing, sale, reimbursement and/or pricing of any Products.
What are the statutory and regulatory requirements?
Both statutory requirements and regulatory requirements are those requirements that are required by law. … ―Statutory refers to laws passed by a state and/or central government, while regulatory refers to a rule issued by a regulatory body appointed by a state and/or central government.‖
What is the purpose of regulatory compliance?
In general, compliance means conforming to a rule, such as a specification, policy, standard or law. Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.
What are regulatory affairs in pharmaceutical industry?
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. … Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug.
What is Pharma ROW market?
United States (US) and the EU are the biggest and the most potential markets for in the world and are categorized under the regulated markets, whereas ROW (Rest of the World) market includes all the emerging markets like Brazil (LATAM), Tanzania (Africa), Russia (CIS), Hong Kong (ASIA), etc.
Why do we need regulatory affairs?
The main objective of regulatory affairs is to provide the basis for the assurance of high quality of food products which can increase consumer’s interest for ensuring the efficacy, quality, and safety.
What is regulated drug?
Answer and Explanation: A regulated drug is one that is researched, manufactured, distributed, and administered under the supervision of regulatory authorities and/or..
What is dossier in regulatory affairs?
A collection of papers giving detailed information about particular person or subject.
Dossier and Regulatory Affairs:
Dossier helps,
- To create, assemble, update and publish a composite document(s) from various individual document sources and formats.
- Each document or sub dossier follows its own lifecycle.
What is the difference between CTD and Actd?
The ACTD consists of Parts I to IV which have subsections A to F whereas ICH-CTD has 5 Modules with subsections that are numbered. The administrative data of Part I is part of ACTD whereas Module
1 of ICH-CTD is purely country specific.
What is dossier preparation?
Abstract: Dossier is a collection of documents on the particular subjects. Any preparation of
pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non-clinical and clinical data.
What are regulatory guidelines?
Regulatory Requirements means all applicable laws, rules, regulations, orders, requirements,
guidelines, interpretations, directives and requests (whether or not having the force of law) from and of, and plans, memoranda and agreements with, any Regulatory Authority.
What are the examples of regulated drugs?
Examples of Schedule II narcotics include: hydromorphone (Dilaudid®), methadone (Dolophine®),
meperidine (Demerol®), oxycodone (OxyContin®, Percocet®), and fentanyl (Sublimaze®, Duragesic®). Other Schedule II narcotics include: morphine, opium, codeine, and hydrocodone.
What needs FDA approval?
Which Products Need FDA Approval?
- Human and animal drugs.
- Medical biologics.
- Medical devices.
- Food (including animal food)
- Tobacco products.
- Cosmetics.
- Electronic products that emit radiation.
How are drugs regulated?
Drug regulation: The process of testing, developing and marketing of medicines has to regulated to
protect the interests of the public. Major regulatory bodies include the Food & Drug Administration
(FDA) in the US and the European Medicines Agency (EMA) in Europe.
What makes good regulatory affairs professional?
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
What is regulatory submission?
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.
What are the 4 stages of drug development?
Drug Development Phases
- Phase 1: Discovery and Development.
- Phase 2: Preclinical Research.
- Phase 3: Clinical Research.
- Phase 4: FDA Review.
- Phase 5: FDA Post-Market Safety Monitoring.
What is CMC in regulatory affairs?
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.
What is CTD format?
The Common Technical Document (CTD) is a set of specifications for an application dossier for the
registration of Medicines and designed to be used across Europe, Japan and the United States. … Quality (pharmaceutical documentation)
How is dossier prepared in pharmaceutical products?
Abstract: Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non-clinical and clinical data.
What does Ich stand for?
International Council for Harmonisation
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.
What is a dossier file?
A dossier is a collection of papers or other sources, containing detailed information about a particular person or subject.
How do you make a dossier?
To create a dossier On the home page or any folder page, click Create, and then select New Dossier. Your dossier is created and displayed, containing a single blank visualization. …
You can add data to the dossier in any of the following ways. … The selected data is added to your dossier as a dataset.
What is eCTD submission format?
eCTD The Electronic Common Technical Document (eCTD) is the standard format forsubmitting applications, amendments, supplements, and reports to FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).
What are FDA guidelines?
About FDA Guidances
Guidance documents represent the Agency’s current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bindFDA or the public.
Is the FDA a regulatory agency?
The Food and Drug Administration (FDA) is a government agency established in 1906 with the passage of the Federal Food and Drugs Act.
What is the difference between compliance and regulatory?
In general, compliance means conforming to a rule, such as a specification, policy, standard or law. Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.
What are the 7 classifications of drugs?
7 Drug Categories
(1) Central Nervous System (CNS) Depressants. CNS depressants slow down the operations of the brain and the body.
(2) CNS Stimulants. (3) Hallucinogens.
(4) Dissociative Anesthetics. (5) Narcotic Analgesics.
(6) Inhalants.
(7) Cannabis.
Do natural products need FDA approval?
The law does not require cosmetic products and ingredients, except for color additives, to be approved by FDA before they go on the market. … You are legally responsible for making sure your cosmetics are safe and properly labeled, in compliance with all the laws and regulations that apply to them.
- What does CMC stand for in drug development?
CHEMISTRY, MANUFACTURING, AND CONTROL
Together, these processes are known in preclinical and clinical development as chemistry, manufacturing, and control (CMC). Many aspects of drug development focus on satisfying the regulatory requirements of drug licensing authorities.
What is the regulatory authority in India for pharmaceutical companies?
The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for Indian
pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines.
Who are the members of ICH?
ICH is now constituted by 16 Members and 28 Observers, after the ICH Assembly in 2018 approved
TFDA, Chinese Taipei as a new Regulatory Member, and MMDA, Moldova, NPRA, Malaysia, NRA,
Iran, SCDMTE, Armenia and TİTCK, Turkey as new Observers.
Is dossier a French word?
“Dossier,” the French word for such a compendium of spine-labeled folders, was picked up by English speakers in the late 19th century. It comes from “dos,” the French word for “back,” which is in turn derived from “dorsum,” Latin for back.
What is a research dossier?
The term dossier refers to the application materials used when applying for academic jobs. … The career development center is available to review all aspects of your dossier with you when you are applying for academic jobs. Below is an overview of teaching portfolios and teaching, research, and personal statements.
What is a dossier in Micro strategy?
About Dossiers. A dossier is an interactive display that you can use to quickly and easily explore your business data. For example, you can: View visual representations of the data (called visualizations) in the dossier to make the data easier to interpret.
What is node extension in eCTD?
Node Extension Node extensions are a way of providing extended organisational information in
the eCTD. The node extension should be visualised as an extra heading in the CTD structure and should be displayed as such when the XML backbone is viewed.
What is FDA CFR?
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration.
What are CGMP guidelines?
The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and
controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
Does FDA regulate alcohol?
The Federal Alcohol Administration Act (―FAA‖) regulates the interstate and foreign commerce of wine, spirits, and malt beverages and bestows general authority to oversee these products to the TTB. Despite this, the labeling of some beers and some wines are regulated by the FDA.
What is a regulatory risk?
Regulatory risk is the risk that a change in laws and regulations will materially impact a security, business, sector, or market.
Why is regulatory compliance?
Protects your company. The regulations are there for a reason – they help protect your business, your
employees, and your customers. Failing to adhere to regulatory compliance requirements can open you up to risks beyond just fines.
What class of drug is crack?
Crack cocaine is a Schedule II substance under the Controlled Substances Act. Schedule II drugs, which include PCP and metham- phetamine, have a high potential for abuse.
What percentage of drugs makes it through clinical trials?
New MIT Study Puts Clinical Research Success Rate at 14 %. Nearly 14percent of all drugs in clinical trials eventually win approval from the FDA — a much higher percentage than previously thought, according to a new study from the MIT Sloan School of Management
What are the 3 main GCP principles?
Three basic ethical principles of equal importance, namely respect for persons, beneficence, and justice, permeate all other GCP principles. Research involving humans should be scientifically justified and described in a clear, detailed protocol.
What are the three parts of a dossier?
Though there is no specifically recognized format, the teaching dossier typically consists of two basic components: a teaching narrative statement or philosophy, which is a short reflective narrative (two to three pages), and an appendix, which consists of supporting documentation.
How do I create a dossier?
To create a dossier. On the home page or any folder page, click Create, and then select New Dossier. Your dossier is created and displayed, containing a single blank visualization. If the Getting Started page is displayed, click Get Started to open the dossier.
What is DMF in pharma?
Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF.
What is NeeS submission?
This Guidance Document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic format to the National Competent Authorities in the EEA (hereafter referred to as NCAs). This document details the requirements for the submission of Non- eCTD electronic Submissions (NeeS).
Who controls the CFR?
The CFR is divided into 50 titles that represent broad areas subject to federal regulation. The CFR annual edition is the codification of the general and permanent rules published by the Office of the Federal Register (part of the National Archives and Records Administration) and the Government Publishing Office.
What does 510k mean?
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
What is dossier in pharma?
―Registration Dossier‖ of the pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product to be approved /registered / marketed in a country
CAREER PATH
The Drug Regulatory Affairs certification course organised with the help of Industry professionals from Regulatory Affairs. Training is recognized across the globe. Because of the increased adoption of the technology in various small and large pharmaceutical companies the participants are able to find the job opportunity easily. The leading companies hire Drug Regulatory Affairs to provide the most complete regulatory reporting which gains productivity in the pharmaceutical firms. The Drug Regulatory Affairs can pursue a wide range of career paths.
The following are the job titles:
- Consultant – Regulatory Affairs Executive
- Regulatory Executive
- RIMS
- Risk management specialist
