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EU Licencing Procedures

EU Licencing Procedures. Jon Sisson Senior Medical Assessor Licensing division, MHRA Date: June 2012. Routes to licensing. National Procedure European Procedures Centralised Procedure Decentralised Procedure Mutual Recognition. Centralised Procedure.

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EU Licencing Procedures

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  1. EU Licencing Procedures Jon Sisson Senior Medical Assessor Licensing division, MHRA Date: June 2012

  2. Routes to licensing • National Procedure • European Procedures • Centralised Procedure • Decentralised Procedure • Mutual Recognition

  3. Centralised Procedure • Legal basis – Council Regulation EC 726/2004 • A single application • A single evaluation • A single European Marketing Authorisation • Operated by European Medicines Agency and its scientific committee, CHMP

  4. Committee for Human Medicinal Products (CHMP) • Composition: Chair, Vice-chair. 1 Delegate and 1 alternate per the 27 Member States (plus IS and NO) - plus up to 5 co-opted members • Member states act as Rapporteurs or do “voluntary” assessment • Delegates are supported by assessor teams in each agency and others from the European experts database • Meets monthly over 4 days at the European Medicines Agency HQ • CHMP is supported by various working parties and other groups e.g. Scientific Advisory Groups • CHMP gives its opinions to the EMA, decisions are issued by the European Commission. Divergence is rare!

  5. Work of CHMP • Centralised licensing work • Referrals • Scientific advice • Guidance • Scientific opinions on wide range of topics • Pharmacovigilance and post-licensing work for centralised products (PSURs, variations, renewals, FUMs)

  6. The big hitters at CHMP…

  7. Centralised Procedure • Mandatory for the following new applications: • Biotechnology products • Orphan drugs • AIDS, cancer, neurodegenerative disorder, diabetes • Autoimmune disease, other immune dysfunction • Other viral diseases • Eligible/Optional at present for: • A new active substance (almost all use CP) • Innovative products with novel characteristics • In the interests of patients at community level • Generics of centrally authorised products

  8. Centralised Procedure Evaluation time table: new applications • Pre-submission meeting with EMA, confirmation of eligibility to CP • Invitations for Rapporteurship - bids made by interested MS • Selection of Rapporteurs by CHMP - 6 months before submission date • Evaluation process completed within 210 days (excluding clock stops) Landmarks • Day 1 –Procedure start (following validation) • Day 80 – Separate Assessment Reports circulated by Rapp & Co-Rapp

  9. Centralised Procedure • Day 100 – Rapporteurs / EMA receive comments from CHMP members (i.e. 20 days for non-Rapp assessment) • Day 115 – Rapporteur circulates draft list of questions incorporating comments from the non-Rapp Member States prior to the main CHMP meeting • Peer review teleconference, draft LoQ amended as necessary

  10. Centralised Procedure • Day 120 – CHMP Meeting • CHMP finalises the list of questions after scientific discussion at the plenary meeting • The overall conclusions and the review of the scientific data may be revised following the discussion • Rapporteurs’ position may be updated • Final list of questions sent to the applicant by EMA CLOCK STOP Opportunity for clarification with Rapporteurs Company has 3 months to respond, can extend to 6 months

  11. Centralised Procedure • Day 121 • Submission of the response by the applicant to the list of questions • CLOCK RESTART (On 11 official dates per year) • Rapp and co-Rapp 30 days to assess responses (very tight to get expert committee input i.e. CHM) • Day 150 • Joint (Rapp / Co-Rapp) response assessment report is circulated to CHMP and the EMA

  12. Centralised Procedure • Day 170 • Deadline for comments from CHMP members to Rapporteurs (i.e. 20 days for non-Rapp assessment) • Day 180 – CHMP Meeting • Discussion by CHMP and decision whether oral explanation and/or list of outstanding issues is needed Clock Stop if oral explanation needed • Day 181– CHMP Meeting – Oral explanation Clock Restart Opportunity for clarification with Rapporteur

  13. Centralised Procedure • Day 185 – Applicant to provide rapporteurs, CHMP members and EMEA final draft of the English SPC, PIL and labelling • Day 210 – – CHMP Meeting - CHMP opinion ****************************************************** • Post Day 210 – Finalisation of translation of SPC, PIL and Labelling in all official languages of the EU • Finalisation of AR and EPAR • Transmission to Commission for a decision

  14. Reminder - Positive CHMP opinion is not the same as a grant of the licence

  15. Decentralised Procedure • Newer procedure: has become very popular and accounts for the largest part of MHRA Licensing work • Intended to address some of the problems encountered in the Mutual Recognition Procedure • Allows involvement of other Member States during initial evaluation and before European phase starts • No withdrawal allowed once European phase has started • Concludes negatively if RMS opinion negative • Otherwise mandatory arbitration if no agreement

  16. The big hitters for the DCP…

  17. Decentralised Procedure • Article 28 (3-5) of Directive 2001/83/EC • For MA in more than one MS – between 2 & 27 • Not available where the product has a marketing authorisation anywhere in EU at the time of application – must use MR procedure • Application based on identical dossier in all MS • Applicant chooses a Member State to act as RMS

  18. Decentralised Procedure • Time table – Assessment step I • D 0 – Start of procedure (follows validation procedure) • D 70 – RMS circulates Preliminary Assessment Report, SPC, PIL and labelling to CMSs • D 100 – CMSs send their comments • D 100-105 – Consultation between RMS, CMSs and applicant • D105 CLOCK STOP – If outstanding issues (invariably…)

  19. Decentralised Procedure During clock stop applicant normally submits draft response for RMS to agree prior to clock re-start. Clock stop duration up to 90 days, can be extended to 180 days • D 106 – On receipt of formal response the RMS restarts the clock • D 106 to120 – RMS updates AR, SPC, PIL & circulates to CMSs • D 120 – Procedure closed if consensus to approve – Proceed to national 30 days step (closure at d120 is rare)

  20. Decentralised Procedure • Time table – Assessment step II • D 120 (Day 0) – Draft AR, SPC, PIL circulated to CMSs • D 145 (Day 25) – CMSs send their comments to RMS. Procedure closed at D150 if consensus reached • Before D160 applicant submits response to outstanding issues raised at D120/145 • D 180 (Day 60) – RMS comment on applicant’s response. If no consensus, outstanding issues to be communicated to the applicant

  21. Decentralised Procedure • Between D 180 and D 205 - Informal communications between RMS and CMSs / applicant as required. Breakout group meeting / TC to reach consensus if required • D 205 (Day 85) – CMSs send their final positions • D 210 – Either: Closure of the procedure including CMSs approval of AR, SPC, PIL. Proceed to national 30 days step for resolution (submission of national translations of SPC, PIL, labels and issue of national licences or Referral to CMD(h)

  22. Decentralised Procedure– CMD(h) Co-ordination Group for Mutual Recognition and Decentralised Procedures (Human) If RMS positive but any CMS negative at D 205: - Dissenting CMSs submit request for RMS to refer to CMD(h) - Only if there is a PSRPH - 60 day procedure to reach consensus if possible. Applicant has the opportunity to present point of view orally or in writing - Day 270 (at the latest) – Final position adopted by CMDh (after 1-2 meetings) with referral to CHMP if issues can’t be resolved. (Same procedure as for no agreement at D90 of MR procedure)

  23. National Procedure • Few new national procedures these days – some generics • Option for companies that wish to restrict marketing to a single market – especially small companies • Or in context of subsequent Mutual Recognition procedure • Still a lot of maintenance activity on older national licences • Details of the procedure obviously vary between MS

  24. Mutual Recognition Procedure • Legal basis: Directive 2001/83/EC • Other MS mutually recognise within 90 days, the Marketing Authorisation granted nationally by the chosen RMS • Less common than DCP now, volumes halved since 2006. In 2011 – 7 times more DCP than MRP for initials • “2nd wave” etc procedures to obtain MAs in additional MSs, also to add member states to a decentralised licence • Difficult procedure when SPCs are different or data contentious. Each new MS can trigger referral, and negative outcome results in revocation or suspension of all MAs

  25. Factors affecting licensing route • Is it in mandatory scope of centralised procedure? • How complex/controversial is the application? • Is medical condition only recognised in some MS, or are there other difficulties in particular MS? • Preference for particular MS to lead • Resources available - to you and to the Agencies involved • Your strategy – licences in which MS? – how soon? what are your longer term plans? • Seek advice from EMA/national agencies

  26. Personal view: tips for a happy medical assessor • Present applications in a user-friendly way, concisely and clearly • Don’t assume the medical assessor is an expert in your therapeutic area – but they will always find someone who is • Be patient with us and get the level of dialogue right • Guidelines are not set in stone, but justify when you diverge from them • It is better to proactively tackle issues in a submission than leave the assessor to discover them (and we will!) • Critically defend what you want to do • Wikipedia is not an assessable reference, neither is an abstract, your SPC or core data sheet!

  27. Thanks for your attention!

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