Rajkumar Gupta, M.Pharm. . Regulatory Mentor at Perfect Pharmaceutical consultants Pot Limited, India. 1 provide professional regulatory services on cGMP Audits/Training, ANDA, NDA IND, CEP, DMF, PV. PSUR, Contact pesfectdossiers@ gmail.com vist: www.perfectdossier com 28. | What are the common Suspension of License regulatory actions for Debarment for manufacturing noncompliance? Debarment for Export Cancellation of marketing Authorization Fine Imprisonment Defamation through public notices/display ‘Compensation for loss/damage due to unwarranted death/injury Recall of the distributed products wosal of stocks Panel enquiry 29. | What are the obligatory | cGMP, GLP, GDP , MAA,ANDA.NDA.CEP, compliances for DMFEDMF, ACTD, SUPAC filings, manufacturing and Pharmacovigilance, PSUR,CT, BA/BE studies, marketing the drugs? Annual reports , Labelin; What is RTF? It isa refusal to filean ANDA/NDA or other submissions by FDA when it is grossly incomplete or when it is improperly presented. 31. | What is Field Copy? ‘The copy of regulatory submission (NDA or ANDA or IND) which is marked for making remarks during Site Audit. 32. | What is priority Review? | IT is a review on priority out of the tum basis. It is generally performed for orphan drugs 33. | Isit possible to register an_ | Yes. It can be registered but the approval will be ANDA before the expiry of granted afier the expiry of the patent filed under NDA holder. the patent? ‘What is six months exclusivity period with reference to ANDA? It isa period during which the original patent holder can question the validity of first generic allowed by FDA 35. | What is orphan drug? ‘The drug which is used for rare diseases affecting very small human population. 36. | Do EMA and FDA are still | No. You need to submit all technical documents: accepting paper electronically in eCTD form submissions? 37. | How eCTD is submitted? | Currently, eCTD is submitted through FDA Gateway on web. However, it can also be submitted on CD ROM or DVD 38. | If clinical and nonclinical | No. data is required for Marketing Authorization of Generic Drugs? 39. | What is annual update? | It isan update in DMF/Dossier/CTD reported at the anniversary date of the product registration with FDA. © Copyright by Mr. Rajkumar Gupta, August 2014 india. All rights reserved.