AHI. Foreign Pre-Approval Inspections (PAIs) Points to Consider

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1 AHI Freign Pre-Apprval Inspectins (PAIs) Pints t Cnsider The fllwing suggestins are intended t prvide spnsr guidance fr timeliness and predictability f freign PAIs. The FDA Center fr Veterinary Medicine (CVM), Office f New Animal Drug Evaluatin (ONADE) in cnjunctin with the FDA Office f Regulatry Affairs (ORA), schedules and cnducts freign PAIs. Infrmatin in this dcument and cmmunicatin between CVM and the spnsr may reduce the number f review cycles fr Chemistry, Manufacturing and Cntrl (CMC) supplements and technical sectins submitted requiring a freign PAI. CVM/AHI Shared Gal: Meet currently established review times by: Cmmunicating in advance the ptential need fr a freign PAI, Maintaining cmmunicatin with respect t changes in the need fr freign PAIs, Utilizing a cmmn frmat fr submitting freign PAI infrmatin t CVM and Increasing the timeliness and predictability f freign PAIs t reduce review cycles.

2 Page 2 f 5 Factrs Affecting Timely PAIs 1. Security a. ORA wrks with the State Department t btain the apprpriate paperwrk t travel t the cuntry cntaining the facility requiring a PAI. b. The amunt f time required t prcess the paperwrk varies fr each cuntry depending n the need fr a visa, security/safety alerts, etc. 2. ORA Timeline a. The timeline fr visas and freign diplmacy via the State Department makes it difficult t meet the 120 day review time. b. The lack f ability t meet the 120 review cycle clck autmatically pushes the submissin t a secnd review cycle if an inspectin is cnsidered necessary after PAIDSS. c. ORA starts planning fr the upcming fiscal year s inspectins in January f the existing fiscal year since freign PAIs can take up t three times lnger than dmestic PAIs t schedule and cnduct. 3. ORA Pririties a. While a Memrandum f Understanding (MOU) between CVM and ORA slidifies ORA s cmmitment t cnduct PAIs fr user-fee animal drug applicatins as high pririty, there may be a diversin f resurces t address natinal emergencies. 4. Investigatr Availability a. The investigatr must be willing t g t the cuntry that cntains the facility requiring a PAI. b. When pssible and the schedule f the investigatr permits, ORA bundles inspectins if several are needed in ne cuntry/regin. 5. Re-inspectin f Vilative Facilities 6. Facility Status Pints t Cnsider fr Submissins with Pssible Freign PAI 1. CVM and ORA wrk tgether a. ORA Meetings with CVM i. CVM meets with ORA quarterly t discuss PAI and ther issues that may exist. ii. CVM shares freign PAI infrmatin fr the fllwing fiscal year with ORA the secnd quarter f the existing fiscal year fr planning purpses. b. Memrandum f Understanding (MOU) i. There is a MOU between CVM and ORA cmmitting t high pririty status f PAIs fr user-fee animal drug applicatins. 1. The MOU cntains timelines and perfrmance gals fr bth CVM and ORA (implementatin f MOU is FY08). 2. CVM and ORA agree t treat freign PAI needs expeditiusly t achieve timely respnses and meet internal perfrmance gals.

3 Page 3 f 5 2. The Agency will keep a recrd f the number f freign PAIs cnducted fr new animal drug applicatins, alng with the average time fr cmpleting the PAIs, and include this infrmatin in its annual perfrmance reprt. The time fr cmpleting the PAI is understd t mean the time frm the date f submitting the inspectin request thrugh ntificatin t the Center f inspectinal findings. 3. Spnsr Cmmunicatin with CVM a. Spnsrs may vluntarily submit: i. At the beginning f the calendar year, a list f freign manufacturing facilities that are subjects f animal drug applicatins, supplemental animal drug applicatins, r investigatinal animal drug submissins and may be subject t freign PAIs fr the fllwing fiscal year; and 1. There is a need fr a cmprehensive and frmatted list f facilities in advance f CVM s Freign Inspectins Submissin template.xls meeting with ORA. Please use the template prvided being as specific as pssible fr the fllwing categries: a. Applicatin Number: INAD r NADA. b. Master File # (if Applicable): DMF r VMF references (type 2, 3, 4 r 5). c. Anticipated Submissins Date, Mnth r FY Quarter (be as specific as pssible). d. Submissin type: technical sectin, refrmulatin, site transfer, etc. e. Prduct r Trade Name: prduct trade name, generic name r cmpund number. f. Dsage Frm: injectables, tablets, pre-mix, etc. g. Activity the Facility Perfrms (Prfile cde): e.g., drug prduct r API manufacturer, cntract sterilizer r labratry, etc., if knwn. h. Full Name and Address f the Facility: include city and cuntry. i. Name and phne number f Cntact fr each applicatin j. US Agent fr all freign facilities (if available): Pint f cntact (name and phne number) in US t set up inspectin (may be submitted in status update letter). k. Inspectin Status - Date f Last inspectin if available: T the best f ur knwledge and updated in letter. CVM can fill in if nt available. l. Other Inspectins: Prvide infrmatin (date and agency) knwn abut ther inspectins (i.e. EMEA r Swiss Medic). Attach translated establishment investigatin reprt (EIR) t the main submissin

4 Page 4 f 5 (supplement NADA r new NADA) r the 30-day ntificatin if available. If there is n access t the reprt, prvide master file infrmatin with the 30- day letter. 2. Cmpanies may submit the spreadsheet as General Crrespndence in cnjunctin with a cver letter. 3. CVM wuld like a CD with the submitted Excel spreadsheet n it s that they may cmbine all the likefrmatted infrmatin in ne file fr their use. 4. Shuld any changes t the annual list ccur after its submissin t the Agency, the spnsr may prvide the updated infrmatin t the Agency thrugh an amendment t the General Crrespndence (see 2 abve). ii. A ntificatin 30 days prir t submitting a new animal drug applicatin, a supplemental new animal drug applicatin, r investigatinal new animal drug submissin that infrms the Agency that the applicatin includes a freign manufacturing facility. Updated infrmatin can als be prvided at this time. 4. Determining the need fr an inspectin a. CVM uses a risk based apprach t Pre-Apprval Current Gd Manufacturing Practices (cgmp) Inspectins fr veterinary drug prducts. i. Use prduct specific infrmatin t aid in risk assessment. ii. Cntent f CMC submissin influences risk based decisin whether r nt an inspectin is needed. A CMC submissin shuld cntain the fllwing: 1. A thrugh descriptin f the prpsed manufacturing prcess r changes in an already apprved manufacturing prcess and apprpriate supprting infrmatin/data, 2. An in-depth understanding f hw prcess variables affect prduct quality, 3. Identificatin f critical cntrl pints and parameters, 4. Apprpriate cntrls t insure prcess is maintained in a state f cntrl and 5. Evidence f apprpriate pst-market mnitring f prduct quality. iii. Multiple risk assessment cntrl pints exist in the Divisin f Manufacturing Technlgies (DMT) PAI prcess fr evaluating cmpliance by firms t cgmp s. iv. An initial assessment which includes infrmatin gathered by the PAI Manager, the apprpriate CMC Reviewer, and the apprpriate Team Leader t determine if an inspectin will be scheduled. If the assessment needs further cnsideratin, it can be referred t the PAI Management Team (Divisin Directr, Team Leaders, and PAI Manager). b. Cmmunicatin with ORA persnnel t discuss areas f high risk is an imprtant cmpnent f the PAI prgram.

5 Page 5 f 5 i. If a decisin is made t inspect in cnjunctin with the review evaluatin, areas f higher risk can be cmmunicated t the apprpriate investigatr t fcus the inspectin. Onging Imprvements 1. Increased cmmunicatins between CVM and ORA a. The MOU with ORA will be revisited n an annual basis. The MOU highlights that ORA s cmmitment t cnduct PAIs fr user-fee applicatins is a high pririty. b. Refinement fr CVM s Pre-Apprval Inspectin Decisin Supprt System (PAIDSS): i. Fcus nly n identified higher risk facilities which have reduced the number f freign PAIs required. ii. Fcus n imprving pr quality submissins. c. Interactins with AHI Manufacturing Review Cycle Team t reduce the number f cycles fr CMC supplements and technical sectin submitted.

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