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21 CFR Part 4 - CGMP for Combination Products

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To understand, through development, implementation and feedback, the 21 CFR Part 4 rule and how it applies to you

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21 CFR Part 4 - CGMP for Combination Products

  1. 1. 21 CFR Part 4Current Good Manufacturing PracticeRequirements for CombinationProductsDocket No. FDA-2009-N-0435FINAL RULEJasmin NUHICApril 2013THIS RULE IS EFFECTIVE 22 JULY 2013
  2. 2. OBJECTIVE• To understand,throughdevelopment,implementation andfeedback, the 21 CFRPart 4 rule and howit applies to you21 CFR Part 4 THIS RULE IS EFFECTIVE 22 JULY 2013 2
  3. 3. TOPICS• Rationale for the final rule• Examples of combination products• Proposed rule• Legal authorities• Assessment and impacts• The final rule• Comments and responses• References and credits21 CFR Part 4 THIS RULE IS EFFECTIVE 22 JULY 2013 3
  4. 4. RATIONALE FOR FINAL RULE• The final rule has two related purposes:– To clarify the cGMP requirements that apply to combination products,– To help ensure the consistent and appropriate application andenforcement of these requirements.• The Food and Drug Administration (FDA) is issuing this regulationon the current good manufacturing practice (cGMP) requirementsapplicable to combination products.• This rule is intended to promote the public health by clarifyingwhich cGMP requirements apply when drugs, devices, andbiological products are combined to create combination products.• In addition, the rule sets forth a transparent and streamlinedregulatory framework for firms to use when demonstratingcompliance with cGMP requirements for ``single-entity and ``co-packaged combination products.21 CFR Part 4 4THIS RULE IS EFFECTIVE 22 JULY 2013
  5. 5. EXAMPLES OF COMBO PRODUCTS21 CFR Part 4 THIS RULE IS EFFECTIVE 22 JULY 2013 5An epinephrine autoinjector by Phillips-Medisize Corp.Drug Eluting Balloon by Medtonic, IncPolyCap ™ System by MicroeDoseTheraupeutxInsulin pump by Medtronic, IncImage curtesy of Food and Drug Administration
  6. 6. PROPOSED RULERULES TITLE APPLIES TO21 CFR Part 210 cGMP In Manufacturing, Processing, Packing, Or Holding Of Drugs; General Drugs21 CFR Part 211 cGMP Finished Pharmaceuticals Pharmaceuticals21 CFR Part 600 cGMP Biological Products: General Biologics21 CFR Part 601 cGMP Biological Products: Licencing Licencing (biologics)21 CFR Part 606* cGMP For Blood And Blood Components Blood21 CFR Part 607 cGMP Establishment Registration And Product Listing For Manufacturers Of HumanBlood And Blood ProductsRegistration (blood)21 CFR Part 610 cGMP General Biological Products Standards General (biologics)21 CFR Part 630 cGMP General Requirements For Blood, Blood Components, And Blood Derivatives General (blood)21 CFR Part 640 cGMP Additional Standards For Human Blood And Blood Products Additional (blood)21 CFR Part 660 cGMP Additional Standards For Diagnostic Substances For Laboratory Tests Additional (labs)21 CFR Part 680 cGMP Additional Standards For Miscellaneous Products Additional (misc)21 CFR Part 820 cGMP Quality System Regulation Devices21 CFR Part 1271 cGMP Human Cells, Tissues, And Cellular And Tissue-based Products Tissue21 CFR Part 4 THIS RULE IS EFFECTIVE 22 JULY 2013 6*NOTE: 21 CFR Part 606 removed as references from 21 CFR Part 4; applicable elements already included in 21 CFR Part 600-680
  7. 7. LEGAL AUTHORITIES• USA– FDA with Food, Drug and Cosmetic Act• Europe (most EU countries and not EU countries)– Medical Device Directive MDD 93/42/EEC– Medicinal Product Directive 2001/83/EC (as amendedby 2004/27/EC)• Other– Indian– Ireland– Etc.21 CFR Part 4 THIS RULE IS EFFECTIVE 22 JULY 2013 7
  8. 8. ASSESSMENTS AND IMPACTS• EconomicImpact• EnvironementalImpact• PaperworkReducation Act21 CFR Part 4 THIS RULE IS EFFECTIVE 22 JULY 2013 8
  9. 9. THE FINAL RULE• The final rule is largely identical tothe proposed rule.• It is organized in four sections:– Addressing scope (Sec. 4.1),– Definitions (Sec. 4.2),– The cGMPs that apply to combinationproducts (Sec. 4.3), and– How to comply with these cGMPrequirements for a single-entity or co-packaged combination product (Sec. 4.4).21 CFR Part 4 THIS RULE IS EFFECTIVE 22 JULY 2013 9
  10. 10. THE FINAL RULE (cont`d)• Subpart A– 4.1 What is the scope of this subpart?– 4.2 How does FDA define key terms and phrases inthis subpart?– 4.3 What current good manufacturing practicerequirements apply to my combination product?– 4.4 How can I comply with these current goodmanufacturing practice requirements for a co-packaged or single-entity combination product?• Subpart B– [Reserved]21 CFR Part 4 THIS RULE IS EFFECTIVE 22 JULY 2013 10
  11. 11. THE FINAL RULE (cont`d)• Amendments to the rule:– On August 9, 2012, NIGC published a final rule amending its enforcement regulation toinclude a graduated pre-enforcement process for voluntary compliance.– That rule referenced a rule that was later withdrawn and also incorrectly referencedan internal citation.– The final rule corrects the error and makes technical amendments to reference theCommission’s recently finalized appeal rules contained in a new subchapter.21 CFR Part 4 THIS RULE IS EFFECTIVE 22 JULY 2013 11
  12. 12. COMMENTS AND RESPONSES• FDA received 25 sets of comments– «demostrate»?– Manufacturing? R&D? Investigational product?– cGMP that apply?– Packaging and co-packaging?– Efforcement and effective date?– Guidance? Aletrnative approaches?– Other21 CFR Part 4 THIS RULE IS EFFECTIVE 22 JULY 2013 12TEN (10) PAGES OF COMMENTS AND RESPONSES
  13. 13. REFERENCES• USA Govenment Printing Office (21 CFR Part 4)– Rule: http://www.gpo.gov/fdsys/pkg/FR-2013-01-22/html/2013-01068.htm• Food and Drug Adminisration (FDA)– Combination products: http://www.fda.gov/CombinationProducts/default.htm21 CFR Part 4 THIS RULE IS EFFECTIVE 22 JULY 2013 13• THANKS TO:– Food and Drug Administration (FDA), Medtronic, Inc (MDT), Phillips-Medisize Corp.,MicroeDoseTheraupeutx, TranSystems
  14. 14. 21 CFR Part 4 THIS RULE IS EFFECTIVE 22 JULY 2013 14

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