Swissmedic Annual Report 2018

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76 Stakeholder management Publications The Agency has a legal mandate to inform the public about specific events relating to therapeutic products. Announcements about first authorisations of medicines, withdrawals of authorisation, and amendments to regulatory requirements are published monthly in the Swissmedic Journal, the Agency’s official periodical. Updates of medicinal product information for healthcare professionals and patients, as well as safety notices and recommended behaviours for therapeutic products, are distributed through various channels (on the Swissmedic website, via electronic newsletters, in industry journals and publications by professional associations or even by writing directly to medical professionals). Activities • In addition to its regular publications – Annual Report, Swissmedic Journal, Vigilance News and the annual reports on haemovigilance and vaccinovigilance – the Agency produced a printed special edition of Vigilance News to coincide with the WHO’s Annual Meeting of Representatives of National Pharmacovigilance Centres in Geneva. • During 2018, Swissmedic published 31 direct healthcare professional communications (DHPCs) and over 675 safety notices and medical device recall notices. It is possible to subscribe to therapeutic product safety information as either a newsletter or RSS feed. • The Swissmedic website www.swissmedic.ch scored significantly more page views in 2018. As in 2017, one fifth of these were from mobile devices. • Once the Federal Council had ratified Therapeutic Products Ordinance Package IV, all the revised Agency Council ordinances and over 600 amended specification documents were published as advance information in a separate section of the Swissmedic website. Website statistics www.swissmedic.ch 884 715 2018 3065 528 154 2778 2017 2016 Users (unique visitors) Average visits per working day 455 904 1795
Stakeholder management 77 Events Swissmedic organises events, information sessions and workshops with the objective of enhancing cooperation with stakeholders and disseminating information. Most specialised presentations are prepared and given by Swissmedic staff. Depending on the topic, guest speakers from other authorities or from industry may also be invited. Swissmedic had contact with over 2,000 stakeholders at various information events, workshops and exhibitions during 2018. It organised a total of 14 events. Activities • The annual EuroMeeting of the Drug Information Association (DIA) took place in Basel. The organisers gave Swissmedic, as the host city’s national regulatory authority, the opportunity to present itself to attendees at its own stand. With its “Taste the innovation” slogan, the stand attracted a lot of attention. • Inspector training courses 2018: Two days of presentations and workshops were devoted to a variety of subjects, such as supplier qualification, active pharmaceutical substance and excipient suppliers, and sampling and analytically testing active substances and excipients. One presentation compared the requirements applicable to food industry quality management systems with requirements in the pharmaceutical industry. All in all, 55 participants from some 15 different countries and eight speakers (foreign GMP inspectors and industry representatives) helped make Swissmedic’s training activities a success in 2018. A third half-day course for Swiss inspectors delivered insights into the changes resulting from the revised Therapeutic Products Act (TPA) and Medicinal Products Licensing Ordinance (MPLO), which entered into force in January 2019. • Three years after the 150th anniversary of the Swiss Pharmacopoeia, another conference was held for experts in this particular field. The level of engagement shown by all attendees was impressive. Speakers from inside and outside the Agency talked about their research work, analyses and experiences. • In conjunction with the Federal Office of Public Health (FOPH) and the Expert Commission for Radiopharmaceuticals (ECRP), Swissmedic organised the first-ever information event for manufacturers and marketing authorisation holders of radiopharmaceuticals. The issues discussed included the regulatory provisions specifically applicable to radiopharmaceuticals. • The Swissmedic information events on the revision of the Therapeutic Products Act were keenly anticipated by stakeholders. Demand for information was so great that two events covering different subjects had to be organised. In total, more than 1,000 people attended. The results of the post-event satisfaction survey showed that attendees were satisfied to very satisfied. • The 41st Annual Meeting of Representatives of National Pharmacovigilance Centres participating in the WHO Programme for International Drug Monitoring was held in Geneva. Swissmedic organised this international meeting, which attracted over 200 participants from 89 different countries, in conjunction with the WHO. To coincide with the meeting, the WHO also staged a special event to mark the programme’s 50th anniversary. • The Clinical Trials division ran a half-day workshop on current issues during 2018, while the Narcotics division organised another “Narcotics information and news” event.
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Annual Report 2018
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3 Contents Foreword by Stéphane Ro
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5 Standards Legal framework Legisla
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7 Raimund Bruhin, director “Not t
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9 The situation subsequently calmed
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11 Basis for development cooperatio
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13 Better protection against defect
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15 undercover investigations in one
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17 Autologous transplant products T
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19 Temporary authorisation: rapid a
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21 Number of authorisations by disp
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Market access | Marketing authorisa
Page 25 and 26: 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: Stakeholder management 75 Press rel
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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