Swissmedic Annual Report 2018

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26 Market access | Marketing authorisation Human Medicines Expert Committee (HMEC) The HMEC is a panel of experts that provides support and advice to Swissmedic when authorisation documents relating to human medicinal products require scientific assessment. Activities • 1,479 applications for an extension of marketing authorisation were completed. • 274 applications for the discontinuation of a product and 16 applications for the discontinuation of a dosage strength of a product were completed. The authorisations of 65 preparations were not extended. Activities • The HMEC advisory panel issued 71 recommendations regarding marketing authorisation applications at its twelve meetings. The majority of them concerned new authorisations or additional indications for medicinal products. Furthermore, the panel was informed of 42 authorisation decisions and invited to comment on them. • In addition, HMEC experts provided 13 expert reports for the purpose of full assessments and 33 reports on individual aspects. A Number of HMEC recommendations relating to marketing authorisation applications 71 2018 73 2017 83 2016 Extensions and discontinuations The marketing authorisation for a human medicinal product is always issued for a five-year period. The authorisation holder must apply for an extension of the authorisation: if the conditions are still met, the authorisation is extended for a five-year period at a time. If the marketing of a medicinal product is discontinued, it is mandatory for Swissmedic to be notified accordingly. The notification must be provided at least two months prior to the discontinuation. The discontinuation of a dosage strength requires approval, since the product information has to be amended. Variations requiring approval and variations requiring notification An application must be made for any variation to a medicinal product authorised by Swissmedic. A finalised list that groups together minor changes may be submitted as a variation requiring notification. All other variations to a medicinal product require approval. These applications are examined with or without scientific assessment. Collective applications and multiple applications are counted as one application. Activities • A total of 5,048 variations requiring notification were submitted, and 5,072 notifications were completed. • 3,683 variations requiring approval with scientific evaluation were submitted and completed. 5072 2018 3683 4817 2017 4083 4665 2016 4075 Completed applications for variations requiring notification Completed applications for variations requiring approval with scientific assessment
Market access | Marketing authorisation 27 The fast-track authorisation procedure Applicants may request adoption of the fast-track procedure for human medicinal products or major variations to such products, provided that three conditions are met: • Expected successful treatment in the case of a serious illness, • Lack of other treatment possibilities with medicinal products or unsatisfactory treatment option, • The use of the medicinal product indicates a significant therapeutic benefit. Once Swissmedic is satisfied that these conditions have been met, the request for the fast-track procedure is approved and a corresponding application may subsequently be submitted. For Swissmedic, the time limit for processing the authorisation application is reduced from 330 to 140 days. Activities • 27 requests for the fast-track procedure to be applied were submitted, and 23 fast-track requests were approved. • 19 authorisation applications were submitted for the fast-track procedure, and 14 were completed. • All of the applications submitted using the fast-track procedure were completed on time. Fast-track requests 2018 2017 2016 Submitted fast-track requests Completed fast-track requests Fast-track authorisation applications 2018 2017 14 18 19 23 23 25 25 27 31 30 2016 16 13 Authorisation applications submitted using the fast-track procedure Authorisation applications completed using the fast-track procedure
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 25: 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 and 44: Market access l Inspections 43 Insp
Page 45 and 46: Market access l Inspections 45 GLP
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
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Stakeholder management 77 Events Sw
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Stakeholder management 79 Collabora
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Stakeholder management 81 • Swiss
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Stakeholder management 83 Special a
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Information technology and telecomm
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Corporate Governance 87 Agency Coun
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Corporate Governance 89 Chair Stép
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91 Remuneration Remuneration for th
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Organisation 93 Members of the Vete
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Organisation 95 Nicole, Messi Mara,
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Balance sheet 97 Balance sheet (in
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Erfolgsrechnung 99
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Swissmedic Annual Report 2018

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