Swissmedic Annual Report 2018

More documents

Recommendations

Info

38 Special activities and events: Authorisation of human and veterinary medicinal products • In preparation for the entry into force of the revised therapeutic products legislation on 1 January 2019, Swissmedic held information events on 25 October and 9 November 2018. Each was attended by about 550 stakeholders. On 30 September 2018, some 340 specification documents were published in four languages on the Swissmedic website in anticipation of the events. The entry into force of the revised therapeutic products legislation marked the provisional high point of a project that had been driven forward with great energy for two and a half years. • Swissmedic presented the changes to quality documentation necessitated by the implementation of the revised therapeutic products legislation at an international workshop held by the Drug Information Association (DIA) in Basel in June 2018. • In a comprehensive study 1 , Swissmedic authors analysed the extent to which the Agency’s authorisation decisions diverge from the decisions made by the EMA and US FDA. The results shed an interesting light on regulatory authorities’ decision making. • The Head of the Market Authorisation sector took part in two panel discussions. The first was organised by Forum Gesundheitswirtschaft Basel (Basel healthcare business forum) and was entitled “Value & values of medicinal product authorisation”, while the second, at ETH Zurich, was on the topic of “Digital Health”. 1 A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA, Therapeutic Innovation & Regulatory Science, 2018, sagepub.com/journalsPermissions.nav, DOI: 10.1177/2168479018764660
Market access | Licensing 39 Licensing Medicinal and transplant products Establishment licences for medicinal products Companies that manufacture or distribute medicinal or transplant products in Switzerland (manufacturing, wholesale, import, export and trade in foreign countries) require an establishment licence. Swissmedic issues this licence on the basis of a successful inspection or other evaluation. Activities • At the end of 2018, 1,099 companies held an establishment licence for the manufacture, wholesale, import, export and trade in foreign countries of medicinal and transplant products. Some companies carry out several of the activities mentioned. The number has been stable for several years. • Once again, more establishment licences were issued, extended, modified or revoked. There were 844 decisions in 2018. Owing to the change in establishment licence format (total revision of the Medicinal Products Licensing Ordinance, MPLO, SR 812.212.1), a large number of renewals were completed prematurely at the end of 2018 using the old format. Special licences for medicinal and transplant products On application and within two working days, Swissmedic issues medical professionals with a special licence for importing small quantities of medicinal and transplant products that are not authorised in Switzerland but are essential for the treatment of specific patients. The import, use or dispensing of these products is the sole responsibility of the medical professional in question. Activities • The number of special licences increased on 2017. The protracted unavailability in Switzerland of a veterinary medicinal product for the prevention of bovine mastitis (antibiotic-free prevention of ascending intramammary infections throughout the dry period) resulted in a large number of requests to import the product in packaging authorised in EU countries. Turning to human medicinal products, the unavailability of certain vaccines contributed to the increase in the number of special licences issued. Performance indicator Establishment licences; proportion of procedures that were completed within six months Target Result 95 % 95 % A Total number of special licences issued 1152 1455 2018 2017 2016 Performance indicator 100 % 99 % Special licences; proportion of procedures that were completed within 24 hours 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 37: Market access | Marketing authorisa
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
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
show all

Swissmedic Annual Report 2018

Create successful ePaper yourself

Delete template?

Save as template?