Rajkumar Gupta, M.Pharm., Regulatory Mentor at Perfect Pharmaceutical consultants Pvt Limited, dia. 1 proside professional regulatory services on GMP Audits/Training, ANDA, NDA IND, CEP, DMF, PV. PSUR, Contact perfectdossiers@ gmail.com visit: www:perfectdossier.com marketing authorization for generic drugs are called as abbreviated new drug application in USA required to hold information on safety and efficacy of the drug products; hence the application is termed as abbreviated. 6. | Does Marketing Yes. Itis necessary for all the products which Authorization is also come under preview of the definition of drug required for veterinary Drugs, Medical Devices, Cosmetics, diagnostics in us? 7. | What is the difference The regulatory system in US is uniform between regulatory system | throughout the state. in US and Europe? ‘The regulatory system in Europe is two tires. Finstly, every state in Europe has own regulatory system governed by state drug authorities Secondly, there are central bodies like EMA & EDQM which govern entire European Union 8. | What is US DMF? 1 isa voluntary filing of admin and technical documents related to quality of drugvexci and packaging materials for review in connection with ANDA/NDA 9._| What is eCTD? Electronic Common Technical documented 10. | Name the different ‘Admin modules included in US| Summary crp? Quality Saiety Efficacy 11. | What are C& P Actions? | The actions designed to Correct and prevent the deviation/unauthorized changes in the quality system 12. | What are CDER, CBER | CDER = Centre of Dig Evaluations and Research and CVP? CBER : Centre for Biological Drugs Evaluations and Research CVP= Centre for veterinary products 13. | What is IND, ANDA and | IND: Investigational New Drug Application NDA? ANDA: Abbreviated New Drug Application NDA : New Drug Application 14. | What is FINN? Who Recommended Intemational Non proprietary maintains the same? Name. It is maintained by WHO 15. | What is patent and ‘The patent proprietary Names are the trade name proprietary name? Who | assigned by the owner of the product assigns it? 16. | What is ICH? Name TCH | ICH stands for International Conference for Core members? Harmonization It has bas ally five members and many observer © Copyright by Mr. Rajkumar Gupta, August 2014 india. All rights reserved.