The Committee for Medicinal Products for Human Use
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1 The Committee for Medicinal Products for Human Use Patrick Salmon IMB Barcelona, 20 June, 2013
2 2 EURORDIS SUMMER SCHOOL 2013 CHMP
3 CHMP... What is it? 3 EURORDIS SUMMER SCHOOL 2013
4 CHMP What is it? The Committee for Medicinal Products for Human Use CPMP, Committee for Proprietary Medicinal Products Responsible for delivering scientific opinion Scientific Committee to provide a single assessment in a predetermined time (210 days) a single licence and product information throughout the European Union (EU) 4 EURORDIS SUMMER SCHOOL 2013
5 Pharmaceutical Legislation First European Community Directive national systems covering marketing authorisations CPMP and MRP Community wide procedures and technical standards International Conference on Harmonisation (ICH) EMA Centralised procedure Orphan Drug Regulation Clinical Trial Directive; Review of legislation 2005/6/7..Implementation of new legislation Reg 1235/2010 and Dir 2010/84/EU Pharmacovigilance PRAC 5 EURORDIS SUMMER SCHOOL 2013
6 CHMP: The history Pre-January national regulatory agencies 15 parallel national reviews 15 independent marketing authorisations Poor utilisation of resource Possible divergent opinions Different information for patients 6 EURORDIS SUMMER SCHOOL 2013
7 CHMP: The history January 1995 Creation of the 16 th regulatory authority European Medicines Agency (EMA) London Centralised procedure Centralised assessment and opinion 7 EURORDIS SUMMER SCHOOL 2013
8 CHMP: The history Single timely (and predictable) assessment resulting in a harmonised scientific opinion and A harmonised licence and harmonised information for health care professionals and patients 8 EURORDIS SUMMER SCHOOL 2013
9 CHMP Members The CHMP is composed of: one member (and an alternate) nominated by each of the 27 EU Member States; mandate lasting 3 years, renewable a chairperson, elected by serving CHMP members; one member (and an alternate) nominated by each of the EEA- EFTA states Iceland and Norway; up to five co-opted members, chosen among experts nominated by Member States or the EMA and recruited, when necessary, to gain additional expertise in a particular scientific area. Members act as Rapporteurs for products or procedures 9 EURORDIS SUMMER SCHOOL 2013
10 CHMP Members Co-opted members Pharmacovigilance Advanced Therapies Statistics Blood Products 10 EURORDIS SUMMER SCHOOL 2013
11 CHMP 11 EURORDIS SUMMER SCHOOL 2013
12 CHMP Role CHMP is responsible for preparing the EMA's opinions on all questions concerning medicinal products for human use: The initial assessment of medicinal products for which a Community-wide marketing authorisation is sought Several post-authorisation and maintenance activities, including the assessment of any modifications or extensions ( variations ) to the existing marketing authorisation In the mutual-recognition and decentralised procedures, the CHMP arbitrates in cases where there is a disagreement between Member States concerning the marketing authorisation of a particular medicinal product ( arbitration procedure ). The CHMP also acts in referral cases, initiated when there are concerns relating to the protection of public health or where other Community interests are at stake ( Community referral procedure ). 12 EURORDIS SUMMER SCHOOL 2013
13 CHMP Responsibilities at time of Marketing Authorisation Assessments (in accordance with EU legislation), based on purely scientific criteria (QSE): Quality (Q) Safety (S) and Efficacy (E) requirements. Positive risk-benefit balance 13 EURORDIS SUMMER SCHOOL 2013
14 CHMP Responsibilities Post-Marketing Authorisation Monitoring of the safety (pharmacovigilance) of authorised products: reports of potential safety concerns ( adverse drug reaction reports, or ADRs) conducted through the national medicines agencies, in close cooperation with healthcare professionals and pharmaceutical companies themselves. The CHMP can make recommendations to the Commission regarding changes to a product s marketing authorisation or the product s suspension/withdrawal from the market. 14 EURORDIS SUMMER SCHOOL 2013
15 CHMP Working Parties CHMP establishes a number of working parties at the beginning of each three-year mandate. with expertise in a particular scientific field, composed of members selected from the European experts list maintained by the EMA. The CHMP consults its working parties on: scientific issues relating to their particular field of expertise, delegates certain tasks to them associated with scientific evaluation of marketing authorisation applications or drafting and revision of scientific guidance documents. 15 EURORDIS SUMMER SCHOOL 2013
16 CHMP Working Parties Supported by over experts Standing Biologics Working Party (BWP) Patients and Consumers Working Party (PCWP) Pharmacovigilance Working Party (PhVWP) Safety Working Party (SWP) Quality Working Party (QWP) Scientific Advice Working Party (SAWP) PRAC 16 EURORDIS SUMMER SCHOOL 2013
17 CHMP Working Parties: Temporary contd Pharmacogenomics Working Party (PgWP) Vaccines Working Party (VWP) Blood Products Working Party (BPWP) Biostatistics Working Party (GTWP) Biosimilar Medicinal Products Working Party (BMWP) Pharmacokinetics Working Party Cardiovascular Working Party Central Nervous System Working Party Infectious Diseases Working Party Oncology Working Party Rheumatology/Immunology Working Party 17 EURORDIS SUMMER SCHOOL 2013
18 CHMP Working Parties: Associated contd Healthcare Professionals Working Group (HCPWG) Invented Name Review Group (NRG) Working Group on Quality Review of Documents (QRD) Geriatric Expert Group Summary of Product Characteristics Advisory Group Modelling and Simulation Working Group Active Substance Master File Working Group Expert Group on the Application of the 3Rs in the Development of Medicinal Groups Co-ordination Group To ensure integrated management of the operation of the scientific committees, working parties and drafting groups. A Guidelines Consistency Group Peer reviews all concept papers, draft guidelines and reflection papers before they are discussed at the CHMP in order to maintain regulatory and scientific consistency. 18 EURORDIS SUMMER SCHOOL 2013
19 CHMP: Scientific Advisory Groups (SAG) Scientific advisory groups are established to provide advice in connection with the evaluation of specific types of medicinal products or treatments. Consist of European experts selected according to the particular expertise required on the basis of nominations from the CHMP or the EMA. Cardiovascular Issues Anti-infectives Neurology Diabetes/Endocrinology HIV/Viral Diseases Oncology Psychiatry Diagnostics Vaccines 19 EURORDIS SUMMER SCHOOL 2013
20 Marketing Authorisation: Decisions All based on same premise of Quality, Safety, Efficacy (QSE) i.e. same technical requirements Four different procedures: Centralised Mutual recognition Decentralised National Irrespective of procedure, underpinned by Good Manufacturing Practise (GMP) requirement for manufacturer, supervised by Member State where manufacturing or importation takes place 20 EURORDIS SUMMER SCHOOL 2013
21 Scientific Guidelines 21 EURORDIS SUMMER SCHOOL 2013
22 CHMP Guidance Proposal from working party, International Conference on Harmonisation (ICH) CHMP circulates proposals for comment Influenced by EFPIA, DIA, TOPRA meetings with working parties Formal adoption Facilitates assessment approval and control Alternative approaches possible.. if justified 22 EURORDIS SUMMER SCHOOL 2013
23 23 EURORDIS SUMMER SCHOOL 2013
24 CHMP Guidelines Implemented six months after adoption Normally prospective Exceptions for public health reasons Published on EMA web site Rules Governing Medicinal Products in EU Volume 1 Legislation (Human) Volume 2 Notice to Applicants Volume 3 Quality, Safety and Efficacy (QSE) Guidelines 24 EURORDIS SUMMER SCHOOL 2013
25 CHMP Assessment 25 EURORDIS SUMMER SCHOOL 2013
26 26 EURORDIS SUMMER SCHOOL 2013 CHMP and Patients Patients' and Consumers' Working Party (PCWP) (EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations) Created to provide recommendations to the EMA and its human scientific committees on all matters of direct or indirect interest to patients in relation to medicinal products. To implement the recommendations for improvement in the following areas: Transparency and Dissemination of Information Product Information Pharmacovigilance Interaction between the EMA/Scientific Committees and Patients Organisations
27 CHMP EMA s scientific committee which produces a single assessment resulting in a harmonised scientific opinion and where appropriate a harmonised licence and harmonised information for health care professionals and patients Many tasks and functions CONSTANT CHANGE 27 EURORDIS SUMMER SCHOOL 2013
28 EMA New Applications 28 EURORDIS SUMMER SCHOOL 2013
29 Level of Evidence Of the granted marketing authorisations: 30 (45%) MAAs included double blinded randomised studies 27 (41%) MAAs included open label studies 8 (12%) MAAs were based on bibliographical data 1 (2%) MAAs were based on case reports Of the rejected marketing authorisations: 15 (37%) MAAs included double blinded randomised studies 23 (56%) MAAs included open label studies 3 (7%) MAAs were based on bibliographical data Case report Bibliographic 2% 12% OL 41% Bibliographic 16% DB 45% DB 33% OL 51% Review of Marketing Authorisation Applications of Orphan Medicinal Products, COMP March EURORDIS SUMMER SCHOOL 2013
30 Time (years) from OD to MA outcome For the granted marketing authorisation applications For the rejected marketing authorisation applications <1 4% <1 2% % >4 32% % % % % 14 >4 54% % Review of Marketing Authorisation Applications of Orphan Medicinal Products, COMP March EURORDIS SUMMER SCHOOL 2013
31 The Future PRAC 31 EURORDIS SUMMER SCHOOL 2013
32 CHMP PRAC 32 EURORDIS SUMMER SCHOOL 2013
33 33 European Regulatory Steps - CHMP CHMP... Constant change
34 34 EURORDIS SUMMER SCHOOL 2013 Thank you for your attention
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