The Science of Submissions Part IA - The principles of the new variation regulation

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About the principles of the new variation regulation, including strategic and operational consideration and the impact on legal roles and responsibilities.

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  • Principles of new variation regulation 20100519 www.ectdconsultancy.com
  • Principles of new variation regulation 20100519 www.ectdconsultancy.com
  • Principles of new variation regulation 20100519 www.ectdconsultancy.com
  • Principles of new variation regulation 20100519 www.ectdconsultancy.com
  • Principles of new variation regulation 20100519 www.ectdconsultancy.com
  • Principles of new variation regulation 20100519 www.ectdconsultancy.com
  • Principles of new variation regulation 20100519 www.ectdconsultancy.com
  • Principles of new variation regulation 20100519 www.ectdconsultancy.com
  • Principles of new variation regulation 20100519 www.ectdconsultancy.com
  • Principles of new variation regulation 20100519 www.ectdconsultancy.com
  • The Science of Submissions Part IA - The principles of the new variation regulation

    1. 1. The Science of Submissions - Part IA Principles of the new variation regulation Hans van Bruggen eCTDconsultancy
    2. 2. Agenda <ul><li>Goal </li></ul><ul><li>Main regulation and guidance </li></ul><ul><ul><li>EC 1234/2008, including Annex III </li></ul></ul><ul><ul><li>Classification guideline </li></ul></ul><ul><ul><li>Request for classification of unforeseen variations </li></ul></ul><ul><ul><li>Intent for worksharing </li></ul></ul><ul><li>Strategical and operational considerations </li></ul><ul><li>Legal roles and responsibilities </li></ul><ul><li>Conclusions </li></ul>Principles of new variation regulation Copyright eCTDconsultancy B.V.
    3. 3. Goal <ul><li>Reduction of the number of variations and administrative burden for Agencies and Industry </li></ul><ul><li>To enable competent authorities to focus on those variations that have a genuine impact on quality, safety or efficacy </li></ul><ul><li>While guaranteeing the same level of public and animal health protection </li></ul>Principles of new variation regulation Copyright eCTDconsultancy B.V.
    4. 4. New Variation Regulation & Guidance <ul><li>Commission Regulation (EC) No 1234/2008 of 24 November 2008 </li></ul><ul><ul><li>http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-1/reg_2008_1234/reg_2008_1234_en.pdf </li></ul></ul><ul><ul><li>Implementation </li></ul></ul><ul><ul><ul><li>1 January 2010 MRP and CP </li></ul></ul></ul><ul><ul><ul><li>1 January 2010 Part of the MSs for NP </li></ul></ul></ul><ul><ul><ul><li>1 January 2011 remainder of MSs for NP </li></ul></ul></ul><ul><li>Guidelines on the operation of the procedures laid down in chapters II, III and IV of the regulation </li></ul><ul><ul><li>http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C: 2009:323:0009:0022:en:PDF </li></ul></ul><ul><li>Classification Guideline </li></ul><ul><ul><li>http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C: 2010:017:0001:0044:en:PDF </li></ul></ul>Principles of new variation regulation Copyright eCTDconsultancy B.V.
    5. 5. EC 1234/2008 for CP/DCP/MRP <ul><li>Type IA variations </li></ul><ul><ul><li>DO AND TELL to be clustered in periodic report (= form of grouping) </li></ul></ul><ul><ul><li>Some to be submitted immediately for admin reasons </li></ul></ul><ul><ul><ul><li>Grouping allowed </li></ul></ul></ul><ul><li>Minor Type IB variations </li></ul><ul><ul><li>TELL, WAIT, DO (30 days for foreseen variations; + <10 days for unforeseen) </li></ul></ul><ul><ul><ul><li>Grouping allowed </li></ul></ul></ul><ul><ul><ul><li>Worksharing allowed if on Annex III </li></ul></ul></ul><ul><li>Type II variations </li></ul><ul><ul><li>Require prior approval </li></ul></ul><ul><ul><ul><li>Grouping allowed if on Annex III (single product) </li></ul></ul></ul><ul><ul><ul><li>Worksharing (multiple products) </li></ul></ul></ul>Principles of new variation regulation Copyright eCTDconsultancy B.V.
    6. 6. EC 1234/2008 for CP/DCP/MRP <ul><li>Grouping variations into one single application: </li></ul><ul><li>Group several variations for one MA </li></ul><ul><ul><li>at same time </li></ul></ul><ul><ul><li>Annex III or agreed with Competent Authority (Article 5) </li></ul></ul><ul><li>Group Type IA variations for multiple MA’s </li></ul><ul><ul><li>same MAH </li></ul></ul><ul><ul><li>same group IA variations </li></ul></ul><ul><ul><li>same relevant Authority </li></ul></ul>Principles of new variation regulation Copyright eCTDconsultancy B.V.
    7. 7. EC 1234/2008 for CP/DCP/MRP <ul><li>Worksharing procedures related to several marketing authorisations are permitted for </li></ul><ul><ul><li>minor variation type IB </li></ul></ul><ul><ul><li>major variation type II </li></ul></ul><ul><ul><li>group of variations </li></ul></ul><ul><ul><ul><li>listed in Annex III or agreed with the competent authority </li></ul></ul></ul><ul><ul><ul><li>do not contain any extensions </li></ul></ul></ul>Principles of new variation regulation Copyright eCTDconsultancy B.V.
    8. 8. Annex III- example <ul><li>All variations in the group are consequential to a given urgent safety restriction and submitted in accordance with Article 22. </li></ul><ul><li>All variations in the group relate to the implementation of a given class labelling. </li></ul><ul><li>All variations in the group are consequential to the assessment of a given periodic safety update report. </li></ul>Principles of new variation regulation Copyright eCTDconsultancy B.V.
    9. 9. Annex III- example <ul><li>One of the variations in the group is a minor variation of type IB; all other variations in the group are minor variations which are consequential to this minor variation of type IB. </li></ul><ul><li>All variations in the group relate solely to changes of administrative nature to the summary of product characteristics, labelling and package leaflet or insert. </li></ul><ul><li>All variations in the group are changes to an Active Substance Master File, Vaccine Antigen Master File or Plasma Master File. </li></ul>Principles of new variation regulation Copyright eCTDconsultancy B.V.
    10. 10. Annex III- example <ul><li>All variations in the group relate to a project intended to improve the manufacturing process and the quality of the medicinal product concerned or its active substance(s). </li></ul><ul><li>All variations in the group are changes affecting the quality of a human pandemic influenza vaccine. </li></ul>Principles of new variation regulation Copyright eCTDconsultancy B.V.
    11. 11. Guidelines on the operation of the procedures laid down in chapters II, III and IV of the regulation <ul><li>Human and Veterinary Medicinal Products </li></ul><ul><li>Procedural guidance on handling CP & MRP </li></ul><ul><li>Type IA variations </li></ul><ul><li>Type IB variations </li></ul><ul><li>Type II variations </li></ul><ul><li>Extensions (grouping with variations) </li></ul><ul><li>Recommendations on unforeseen variations </li></ul><ul><li>Urgent Safety Restrictions </li></ul><ul><li>Human influenza vaccines </li></ul><ul><li>Human influenza pandemic vaccines </li></ul>Principles of new variation regulation Copyright eCTDconsultancy B.V.
    12. 12. Classification Guideline <ul><li>Lists </li></ul><ul><ul><li>All foreseen variations </li></ul></ul><ul><ul><li>Conditions to be fulfilled </li></ul></ul><ul><ul><li>General documentation to be submitted </li></ul></ul><ul><li>Will be updated regularly </li></ul><ul><li>Parts to be copied into or next to application form </li></ul><ul><li>Subdivided in </li></ul><ul><ul><li>Administrative </li></ul></ul><ul><ul><li>Quality </li></ul></ul><ul><ul><li>Safety, efficacy and pharmacovigilance </li></ul></ul><ul><ul><li>PMF/VAMF </li></ul></ul><ul><li>http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-2/c/classification_guideline_2010-02_en.doc </li></ul>Principles of new variation regulation Copyright eCTDconsultancy B.V.
    13. 13. Request classification unforeseen variation (Art. 5) <ul><li>Not possible to reclassify </li></ul><ul><li>Feedback within 45 days, followed by publication (no deadline) </li></ul><ul><li>For CP </li></ul><ul><ul><li>http://www.ema.europa.eu/pdfs/human/regaffair/Art5_Application_Form.doc </li></ul></ul><ul><ul><li>eMail to [email_address] for CP </li></ul></ul><ul><ul><ul><li>CAP-<Product name>-Art. 5 variation classification request in the subject field </li></ul></ul></ul><ul><li>For MRP/DCP </li></ul><ul><ul><li>http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/Variations/CMDh_162_2010_Rev0_Jan10_Template.dot </li></ul></ul>Copyright eCTDconsultancy B.V. Principles of new variation regulation
    14. 14. Intent for a worksharing procedure to the EMEA <ul><li>Advised to inform the Agency at least 3 months in advance </li></ul><ul><ul><li>Shorter pre-submission phases possible for </li></ul></ul><ul><ul><ul><li>CP only </li></ul></ul></ul><ul><ul><ul><li>Concern USR </li></ul></ul></ul><ul><ul><ul><li>Changes requested by CHMP </li></ul></ul></ul><ul><li>Letter of intent http://www.ema.europa.eu/pdfs/human/regaffair/Letter_of_intentWS_procedure.doc </li></ul><ul><ul><li>Type(s) and scope of variation(s) </li></ul></ul><ul><ul><li>Overview of MAs concerned and belong to the same MAH </li></ul></ul><ul><ul><li>Explanation / justification for suitability of worksharing </li></ul></ul><ul><ul><li>Rapporteurs and RMSs of the medicinal products </li></ul></ul><ul><ul><li>MAH target submission date </li></ul></ul><ul><ul><li>MAH contact person for the worksharing procedure </li></ul></ul>20100519 Principles of new variation regulation
    15. 15. Strategic and operational considerations <ul><li>Periodic updates causes incompliant dossiers </li></ul><ul><li>Worksharing needs to be requested; could take 3 months </li></ul><ul><ul><li>Considerable delay if not be granted </li></ul></ul><ul><li>Slowest validation determines actual start of procedure </li></ul><ul><li>Highest variation determines time schedule for all </li></ul><ul><li>Issues for one product can delay all products </li></ul><ul><li>Strategic benefit should outweigh the operational problems associated to eCTDs for grouping and worksharing across products </li></ul>20100519 Principles of new variation regulation
    16. 16. Legal roles and responsibilities <ul><li>For grouping and worksharing a single person is responsible, though often other persons have been authorised per product (procedure) per country </li></ul><ul><li>How to explain who the (Co-)Rapporteurs are? </li></ul><ul><ul><li>Apparently not in Annex A </li></ul></ul><ul><ul><li>Apparently not in Annex B (not for CP!?) </li></ul></ul><ul><ul><li>Separate unclassified document to be created </li></ul></ul><ul><li>How to explain who the RMS representatives are? </li></ul><ul><ul><li>Apparently not in Annex B (RMS but not the representatives) </li></ul></ul><ul><ul><li>Separate unclassified document to be created </li></ul></ul>20100519 Principles of new variation regulation
    17. 17. Conclusions <ul><li>Periodic updates </li></ul><ul><ul><li>Needs to be maintained internally on an ongoing basis </li></ul></ul><ul><ul><li>Causes out of compliance dossiers </li></ul></ul><ul><ul><li>Easy to submit </li></ul></ul><ul><li>Grouping within a product </li></ul><ul><ul><li>Easy to handle </li></ul></ul><ul><ul><li>Maintains compliant dossiers </li></ul></ul><ul><li>Grouping and worksharing across products </li></ul><ul><ul><li>Still complex maintenance of documentation internally </li></ul></ul><ul><ul><li>Other distribution of roles and responsibility </li></ul></ul><ul><ul><li>Eases the procedural follow up (no or less diverting dossiers) </li></ul></ul><ul><ul><li>Might increase duration </li></ul></ul><ul><ul><li>eCTD handling ??? </li></ul></ul>20100519 Principles of new variation regulation
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