Swissmedic Annual Report 2018

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44 Market access l Inspections GCP and GVP inspections Swissmedic carries out random inspections of clinical trials of medicinal products in Switzerland. Good Clinical Practice (GCP) inspections focus on whether the safety and personal rights of trial participants are guaranteed. They also verify whether the trials are being conducted in accordance with the scientific criteria for quality and integrity. Inspections may examine circumstances relating to one or more clinical trials. They can focus both on the way trial centres are conducting a trial (trial centre inspection) and on the way pharmaceutical companies, contract research organisations (CROs), pharmacies and research organisations or units are managing it. After it has approved a human medicinal product in Switzerland, Swissmedic conducts pharmacovigilance inspections of authorisation holders (pharmaceutical companies), as well as of CROs and organisations contracted by authorisation holders to carry out pharmacovigilance-related activities on their behalf. These inspections assess whether the pharmacovigilance processes operated by the companies, CROs or organisations being inspected comply with applicable national laws, international Good Vigilance Practice (GVP) directives and Swissmedic requirements. Activities • In 2018, Swissmedic carried out 22 GCP inspections of clinical trials involving medicinal products authorised in Switzerland, including one trial in Germany and one in the UK. • Swissmedic also carried out 12 GVP inspections in Switzerland. • Within the framework of the Geneva-based PIC/S (Pharmaceutical Inspection Co-operation Scheme) convention, Swissmedic participated in two GCP inspection programmes (in Norway and Germany) and one GVP inspection programme (in Lithuania). One of the 12 GVP inspections conducted in Switzerland was also part of the PIC/S programme. • Swissmedic’s GCP/GVP inspectors participated in the EMA’s Inspectors Working Groups once again in 2018. • One GCP inspection was carried out in the transplant products sector during 2018. Performance indicator 100 % 127 % GCP/GVP inspections; degree to which the annual plan was fulfilled Target Result
Market access l Inspections 45 GLP inspections Inspections for third parties For authorisation in Switzerland, non-clinical assessments for notification or authorisation procedures must, with the exception of pharmacodynamic testing, be carried out in accordance with Good Laboratory Practice (GLP). Swissmedic’s GLP unit carries out monitoring activities (inspections or study audits) with the relevant divisions of the Federal Office for the Environment (FOEN) and the Federal Office of Public Health (FOPH) within the framework of the GLP monitoring programme. Additional requirements imposed by other authorities, such as those for medical devices imposed by the Food and Drug Administration (FDA) in the USA, are also taken into account. Swissmedic can provide services for third parties subject to payment of a fee. On behalf of the Federal Office of Public Health (FOPH), Swissmedic carries out inspections and other implementation tasks in the fields of transplants and genetic tests on humans. Swissmedic also performs some of the inspection activities in the therapeutic products sector for the Principality of Liechtenstein. Activities • Swissmedic carried out 16 inspection procedures on behalf of the FOPH. Activities • Swissmedic’s specialist GLP unit inspected GLP compliance at a total of seven assessment facilities and one service provider. • One assessment facility left the Swiss GLP monitoring programme at its own request, while a further facility scaled back its activities substantially. • Cooperation with the GLP units at the FOPH and FOEN were further stepped up, particularly as regards inspector training and inspection planning. Performance indicator 100 % 100 % GLP inspections; degree to which the annual plan was fulfilled Target Result
Page 1 and 2: Annual Report 2018
Page 3 and 4: 3 Contents Foreword by Stéphane Ro
Page 5 and 6: 5 Standards Legal framework Legisla
Page 7 and 8: 7 Raimund Bruhin, director “Not t
Page 9 and 10: 9 The situation subsequently calmed
Page 11 and 12: 11 Basis for development cooperatio
Page 13 and 14: 13 Better protection against defect
Page 15 and 16: 15 undercover investigations in one
Page 17 and 18: 17 Autologous transplant products T
Page 19 and 20: 19 Temporary authorisation: rapid a
Page 21 and 22: 21 Number of authorisations by disp
Page 23 and 24: Market access | Marketing authorisa
Page 35 and 36: 35 Variations requiring approval an
Page 39 and 40: Market access | Licensing 39 Licens
Page 41 and 42: Market access | Licensing 41 Clinic
Page 43: Market access l Inspections 43 Insp
Page 47 and 48: Market access | Licensing 47 Licens
Page 49 and 50: Market access | Licensing 49 Analys
Page 51 and 52: Market access | Medicinal products
Page 61 and 62: Market access | Medical devices 61
Page 67 and 68: Standards 67 Standards Legal framew
Page 69 and 70: Standards 69 Pharmacopoeia The phar
Page 71 and 72: Penal law 71 Investigative measures
Page 73 and 74: Penal law 73 Decisions / verdicts b
Page 75 and 76: Stakeholder management 75 Press rel
Page 77 and 78: Stakeholder management 77 Events Sw
Page 79 and 80: Stakeholder management 79 Collabora
Page 81 and 82: Stakeholder management 81 • Swiss
Page 83 and 84: Stakeholder management 83 Special a
Page 85 and 86: Information technology and telecomm
Page 87 and 88: Corporate Governance 87 Agency Coun
Page 89 and 90: Corporate Governance 89 Chair Stép
Page 91 and 92: 91 Remuneration Remuneration for th
Page 93 and 94: Organisation 93 Members of the Vete
Page 95 and 96:
Organisation 95 Nicole, Messi Mara,
Page 97 and 98:
Balance sheet 97 Balance sheet (in
Page 99 and 100:
Erfolgsrechnung 99
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Swissmedic Annual Report 2018

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