regulatory affairs.pptx

ANDA regulatory approval process

1. ANDA REGULATORY APPROVAL PROCESS SUBMITTED BY : NISHA . N M PHARM 1 ST SEM DEPARTMENT OF PHARMACEUTICS

2. CONTENTS ABBREVIATED NEW DRUG APPLICATION (ANDA) STEPS INVOLVED IN THE APPROVAL OF ANDA

3. ABBREVIATED NEW DRUG APPLICATION (ANDA) These are submitted to the FDA’S CDER (Center for drug evaluation and research ) . The office of the generic drugs (OGD) is located within the CDER under the office of pharmaceuticals science , to obtain approval to market a generic drug product. The OGD ensures the safety and efficacy of the generic drugs by employing a review process that is similar to the NDA process .

4. Once approved the applicant may manufacture and market the generic product to provide a safe, effective and low cost alternative . These are termed “ Abbreviated “ because they generally need not include preclinical and clinical data to establish safety and effectiveness . They must scientifically demonstrate that their product is bioequivalent to the innovator drug . The primary difference between the generic drug review process and NDA process is the study requirements .

5. For ex : an ANDA generally requires a BE study between the generic drug product and the reference list of drugs . The safety and efficacy of the RLD product were established previously through animal , clinical , BA studies . SO , no need to repeat for ANDA.

6. STEPS : Filling Review Coordination of generic drug review process Bioequivalence review process Chemistry review process Labeling review process Putting it all together

7. FILLING REVIEW The process begins when the applicant submits an ANDA to OGD. The document room staff assigns it an ANDA number and stamps a received date on the cover letter of ANDA . It is sent to consumer safety technician of review the preliminary sections of ANDA checklist . Within first 60 days – submission , filling review is completed . Regulatory support branch (RSB) is responsible for this process .

8. Once the RSB completes filling review of the ANDA and verifies that the applicant contains all the necessary regulatory requirements and “ Acknowledgement “ letter is issued to the applicant indicating its acceptance for the filling and official filling date . The applicant is then assigned to technical reviewers. If the ANDA does not meet the criteria for filling , a “ refuse - to – receive “ letter is issued with a list of deficiencies .

9. Upon filling an ANDA the RPM ( regulatory program manager ) forwards an established evaluation request (EER) to the office of compliance. Office of compliance are operating in compliance with current good manufacturing practice ( cGMP ) regulations . Currently ANDA can be submitted electronically . All applicant who planned to submit ANDA electronically should consult CDER’s website for electronic submission .

10. COORDINATION OF THE GENERIC DRUG REVIEW PROCESS : Now application enters the review queue , this means that the application is assigned to a bioequivalence reviewer , a chemist and the labeling reviewer. Each chemistry team consists of a team leader , project manager and several reviewers . The chemistry project manager serves as a Applicant Project manager ( APM) , they plan organize and coordinate all the review activities for the application that they manage .

11. BIOEQUIVALENCE REVIEW PROCESS Bioequivalence project manager (BPM) access list of pending ANDA assign to each individual reviewers according to “ first-in , first-reviewed “ policy . The DBE’S responsibility include BE section of ANDA , Bio-investigational applications , protocols and controlled correspondence . This process establishes BE between a proposed generic drug and the RLD .

12. CHEMISTRY REVIEW PROCESS The chemistry , manufacturing and control (CMC) section of the application is assigned to the chemistry division and the team based on therapeutic category of the drug product . The team leader assign the application to a reviewer on his/her team according to the first-in , first-reviewed policy . The chemistry division reviews CMC section of ANDA , drug master file , annual reports , and controlled correspondence .

13. LABELLING REVIEW PROCESS Labeling section of the application is assigned to the labeling reviewer based on the therapeutic category of the drug product . The labeling review branch is a part of DLPS . The team leader oversees the work of 4-6reviewers . The basics of the labeling review is to ensure that the generic drug labeling is the same as the RLD labeling . The labeling reviewer identifies and resolvers concern about medication errors .

14. The reviewer must identify the RLD . Next step is to find the most recently approved labeling for the RLD . If it is not the recently approved , it is considered as discontinuous . The applicant may submit four copies of draft labeling or 12 copies of final printed labeling as the proposed labeling . The labeling branch supports the submission of electronic labeling which is preferred and strongly encouraged .

15. PUTTING IT ALL TOGETHER After the final office level administrative review and individual disciplines have resolved their deficiencies , the application will either receive a full approval or a tentative letter . When the review of an ANDA is completed , the APMs draft the app approval and circulate it with reviews and application of occurrence . The APMs communicate with the OGD management on a weekly basis to update them on the progress of reviews .

16. A full approval letter details the condition of approval and allows the applicant to market the generic drug product . A tentative approval letter is issued if there are unexpired patents or exclusivities according to the RDL , and delays the marketing of product . Once the office director signs the final approval letter , APM calls and faxes a copy of approval letter to the applicant . The document room staff then mails the final approval letter to the applicant .

17. REFERENCE https://www.bing.com/search?q=anda+regulatory+approval+process+slideshare&qs=HS&pq=anda+regulatory+approval+process+&sc=1033&cvid=18A1D33ADCD74EEFB934BD50E6A43E2B&FORM=QBRE&sp=1&ghc=1&lq=0# https:// www.slideshare.net/sagarsavale1/abbreviated-new-drug-application-anda-63215622

18. QUESTIONS Explain in detail about ANDA regulatory approval process ? ( Nov 22-23)