Continuous dialogue from product development Continuous dialogue from product development throughout product life cycle throughout product life cycle Tomas Salmonson Salmonson Tomas Vice chair CHMP Vice chair CHMP
Outline of presentation � The network of EMEA committees and The network of EMEA committees and � working parties working parties � Statistics on SA/PA Statistics on SA/PA � � Rapporteur Rapporteur /Co /Co- -Rapporteur Rapporteur Appointment Appointment � � Interaction with Interaction with Rapporteurs Rapporteurs � � Post authorisation dialogue Post authorisation dialogue �
Outline of presentation � The network of EMEA committees and The network of EMEA committees and � working parties working parties
Interaction between Committees Interaction between Committees 27 EEA Member States 27 EEA Member States + 3,000 European experts + 3,000 European experts EU institutions: EU institutions: Commission - Parliament Commission - Parliament Management Board Management Board Committee for Herbal Committee for Veterinary Committee for Herbal Committee for Veterinary Medicinal Products Medicinal Products Medicinal Products Medicinal Products (HMPC) (CVMP) EMEA (HMPC) (CVMP) EMEA Secretariat Secretariat Committee for Orphan Committee for Orphan Paediatric Committee Paediatric Committee Medicinal Products Medicinal Products (PDCO) (PDCO) (COMP) (COMP) Committee for Human Committee for Committee for Human Committee for Medicinal Products Advanced Therapies Medicinal Products Advanced Therapies (CHMP) (CAT) (CHMP) (CAT)
Interactions between between Committees Committees Interactions • PDCO PDCO- -CHMP: CHMP: regular regular meetings of Chairs, meetings of Chairs, • "informal informal", CHMP ", CHMP members members at at PDCO PDCO " • COMP COMP- -CHMP: CHMP: regular regular meetings of Chairs, meetings of Chairs, • "informal informal", CHMP ", CHMP members members at at COMP COMP " • SAWP: SAWP: members members from from COMP COMP • • SAWP SAWP- -PDCO: PDCO: being being developed developed • • PDCO PDCO- -other other CHMP WP: CHMP WP: being being developed developed, , • coordination on overlapping overlapping topics topics, joint WP, PDCO , joint WP, PDCO coordination on to provide provide input input into into CHMP guidelines CHMP guidelines to • CAT CAT- -CHMP: CHMP: being being developed developed •
Outline of presentation � The network of EMEA committees and The network of EMEA committees and � working parties working parties � Statistics on SA/PA Statistics on SA/PA �
Scientific Advice and Protocol Assistance 2002-2008 2002 2003 2004 2005 2006 2007 2008 Total SA/PA 86 97 122 194 259 288 321 Protocol 11 17 29 44 50 41 45 Assistance
Scientific Advice and Protocol Assistance 2002-2008 By ATC codes J General anti-infectives for systemic use B Blood and blood forming organs R Respiratory system V Various 3% 10% A Alimentary tract and metabolism 6% 26% 5% H Systemic hormonal preparations, excluding sex hormones 3% C Cardiovascular system M Musculo-skeletal system N Nervous system G Genito-urinary system and sex 0% hormones 14% S Sensory organs 3% 1% P Anti-parasitic products, 15% 8% 2% 4% Insecticides, Repellents L Anti-neoplastic and immunomodulating agents D Dermatologicals
Scientific Advice SAWP Chair → → presents presents ∼ 6 advices advices at at CHMP meeting CHMP meeting SAWP Chair ∼ 6 CHMP members members → 1 thorough thorough peer peer- -review review / / each each main main advice advice CHMP ≥ 1 → ≥ → → → → ≥ ≥ ≥ ≥ → → ≥ ≥ comment during during SAWP SAWP presentation presentation at at CHMP meeting CHMP meeting comment CHMP / EWP Chairs → → attend SAWP meeting to attend SAWP meeting to summarize summarize CHMP CHMP decisions decisions CHMP / EWP Chairs with ciritical ciritical impact on impact on SA SA’ ’s s with SAWP secretariat secretariat → → liaise liaise with with PDCO for PDCO for paediatic paediatic SA SA’ ’s s / / PA PA’ ’s s SAWP PDCO Chair or representative representative → → informs informs CHMP of CHMP of critical critical PDCO PDCO decisions decisions PDCO Chair or
Proportion of MAAs MAAs that received SA that received SA Proportion of (by outcome year) (by outcome year) SA given 60% 56% 50% 47% 40% 38% 30% 20% 10% 0% 2006 (n=50) 2007 (n=59) 2008 (n=70)
Does compliance with SA influence the outcome? MAAs between 2004-2007 192 MAAs with an outcome • Positive opinion – 140 (72.9%) 52 (27.1%) • Negative opinion – 10 (5.2%) • Withdrawal – 42 (21.9%) • Non-orphans drugs – 141 (73.4%) • Orphan drugs – 51 (26.6%)
Does compliance with SA influence the outcome? The 72 MAA outcomes with SA (2004-2007) were assessed concerning compliance with: – Choice of primary endpoint – Choice of comparator – Statistical analyses • Non-compliance defined as not adhering to one or more of the 3 variables • 10 MAAs did not include questions concerning any of the 3 variables • 62 MAA outcomes with SA analysed
SA compliance and MAA outcome advice * compliance * outcome ratios 37 130 99 93 = 0.66 no 150 14 192 20 no yes 6 62 yes 1 41 42 = 0.98 42 41
MAAs: outcome 2008 (jan – nov) �� �� �� �� �� �� �� � �� � � � � � � � � ����������� ���������� ����������� ��������� ����������� ����� �� ��������� ���
Outline of presentation � The network of EMEA committees and The network of EMEA committees and � working parties working parties � Statistics on SA/PA Statistics on SA/PA � � Rapporteur Rapporteur /Co /Co- -Rapporteur Rapporteur Appointment Appointment �
� Members still state relative priority � Collated by EMEA Secretariat � Proposal made by CHMP Chair � best available scientific expertise � highly subjective judgement � experience over time
Rapporteurship appointment � Once eligibility confirmed and if submission within 6-months, appointment of Rapporteurs and their assessment teams take place � CHMP Secretariat sends list of products requiring Rapporteurs appointment at the next CHMP meeting to all CHMP members � Within 2 weeks CHMP members asked to express their interest and provide details regarding their proposed assessment team � Quality, non-clinical, clinical, environmental assessment, pharmacovigilance… � Experience with similar therapeutic area, similar products � Regulatory experience
Rapporteurship appointment (2) � EMEA internal review of the nominations received � Filter information received and propose draft outcome � No linkage/exclusion due to role as Scientific Advice Co-ordinator � Discussion of draft outcome with CHMP Chair on Monday CHMP week � CHMP Chair makes final proposal according to objective criteria in line with best available scientific expertise (http://www.emea.europa.eu/pdfs/human/regaffair/12406605en.pdf) � Adoption of Rapporteurs appointment by the Committee � Outcome letters sent to applicants during the week following CHMP meeting
Rapporteurship appointment Total Rapporteurs appointment Rapporteurship Oct 2006 - Jan 2009 Co-Rapporteurship 80 70 60 50 40 30 20 10 0 UK DE NL SE ES FR DK PT IE BE HU FI IT AT NO EE SL LT PL CZ GR
Role of the Peer Reviewer � Appointed at the same time of Rapporteurs but detail not shared with applicants � To contribute to quality assurance of the List of Questions � Peer Review may encompass whole or part of Q / S / E � Peer Reviewer systematically address � Extent to which scientific argumentation supports proposed LoQs � Consistency issues raised LoQs and CHMP guidelines / Scientific Advice and similar issues seen with products same class / indication � EMEA Peer Review Team also appointed � CHMP members also contribute to review system
����������������������������� 80 80-100 100 107 112 115 120 Reports Peer Comments Draft Tele- Draft CHMP Adopts LOQ Review LOQ conference LOQ � ���������������������������������������� ����������������������� ������� � ����������������������������� � �������������������������������������� ���� �� �������� ������ � ������� � !�����������"#$�%�������&���������'%�&(
Peer review appointment Apr 05 - Sept 06 Peer Review Oct 06 - Jan 09 Total 60 50 40 30 20 10 0 DE SE FR DK EE NL PT ES IE CZ NO UK AT HU FI MT LU PL LT BE IT IC GR
Outline of presentation � The network of EMEA committees and working parties � Statistics on SA/PA � Rapporteur /Co-Rapporteur Appointment � Interaction with Rapporteurs
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