There is a common questions from newly graduated pharmacist -'How do I prepare for a regulatory affairs interview?' In reply of this questions we try to arrange few questions and answer for regulatory affair job exam preparation -
Q1. 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.
Q2. 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.
Q3. What are the types of DMF’s?
- Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- 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
Q4. What is an ASMF?
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)”
Q5. What is an Investigational New Drug (IND) application?
It is an application which is filled with FDA to get approval for legally testing an experimental drug on human subjects in the USA.
Q6. Define Loading dose and Maintenance dose?
Loading dose: The loading dose is one or a series of doses that may be given at the onset of therapy with the aim of achieving the target concentration rapidly.
Maintenance dose: In most clinical situations, drugs are administered in a series of repetitive doses or as a continuous infusion to maintain a steady-state concentration of drug associated with the therapeutic window.
Q7. Which type of tablets are exempted from Disintegration testing?
Chewable Tablets and extended release tablets are exempted from Disintegration testing.
Q8. What is Xenobiotics?
A xenobiotic is a chemical which is found in an organism but which is not normally produced or expected to be present in it. It can also cover substances which are present in much higher concentrations than are usual. Specifically, drugs such as antibiotics are xenobiotics in humans because the human body does not produce them itself, nor are they part of a normal diet.
Q9. What is the potency of a drug?
Drug potency refers to the relative amount of a drug required to produce a desired response. Drug potency is also used to compare two drugs.
Q11. What is CTD?
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.
Modules of CTD -
- 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)
Q12. What is ICH?
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.
Q13. 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.
Q14. 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 “.
Q15. What is an Investigational New Drug (IND) application?
It is an application which is filled with FDA to get approval for legally testing an experimental drug on human subjects in the USA.
Q16. What are the Roles of Regulatory Affairs 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.
Q17. What is ACTD?
ACTD stand for ASEAN Common Technical Dossier. ACTD is organized in four parts -
1. Part I: ToC, Administrative Data and Product Information
2. Part II: Quality Document
3. Part III: Nonclinical Document
4. Part IV: Clinical Document
Q18. What is the difference between CTD and ACTD?
The ICH CTD is divided into 5 modules whereas the ACTD contains of 4 parts, ie., contents wise ACTD is similar to the ICH CTD. But Module wise it is different. Part II of the ACTD contains the pharmaceutical-chemical-biological documentation (the quality information), which corresponds to the ICH Module 3.
Q19. What Are The Goals Of Regulatory Affairs Professionals?
- Protection of human health
- Ensuring safety, efficacy and quality of drugs
- Ensuring appropriateness and accuracy of product information
- Ensuring legal activities
- Applications for new active substances are described as 'full applications'.
- Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’.
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