Swissmedic Annual Report 2018

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18 Outlook CAR-T cell therapy In CAR-T cell therapy, a patient’s own T cells are harvested and genetically engineered with chimeric antigen receptors (CARs). This is done with the aid of viral vectors, which transfer the genetic information in the CARs to the T cells and insert them stably into the T cells’ genome. This ensures that the genetic information from the CARs is transmitted to the cells even when they divide or are activated. Although research has been in progress for over 30 years, CAR-T cell-based products are only just starting to reach a stage of development where they can be administered to patients. While these products represent a beacon of hope for cancer patients, they can also cause serious adverse reactions. Some have already been authorised for international marketing. However, more than 500 clinical trials are currently underway in a variety of indications, as efforts continue to further study and verify the products’ risk-benefit ratio. Swissmedic holds a leading position in these innovative treatments and is closely following developments in the field. Since CAR-T cell-based products look set to usher in a new era in cancer treatment, a large number of institutions intend to submit applications for authorisation to administer their products to patients. New variations structure With the entry into force of the revised Therapeutic Products Act, the legal and regulatory requirements for submitting, reviewing and approving variations for authorised medicines have been aligned with EU. Two full-day information events were held to accompany the introduction of this new variation structure. A list of the questions asked at these events was published on the Swissmedic website along with the associated answers. The following types of variation now exist: • Type IA/IA IN variations – minor variations that have to be notified within no more than one year of implementation in the case of type IA or within 30 days in the case of type IA IN (“do and tell” procedure) • Type IB variations – minor variations that have to be notified prior to implementation (“tell and do” procedure) • Type II variations – major variations that could have a substantial impact on the quality, safety and efficacy of the medicinal product and which must be notified prior to implementation • Extensions Swissmedic applies more liberal requirements for submitting multiple applications than the EU. For example, it accepts multiple applications covering quality and clinical aspects. It is important to note here that it will be possible in the future to submit extensions as a type II variation and thus obtain a shorter time limit than before. All these measures aim as far as possible to harmonise regulatory processes with the EU, as well as to simplify them and, where feasible, to accelerate them.
19 Temporary authorisation: rapid access to medicinal products to treat lifethreatening and debilitating diseases Temporary authorisation provides a way of giving affected patients and animals access to medicinal products for the treatment of life-threatening diseases as quickly as possible, provided certain legal requirements are met (Art. 9a TPA). It thus equips Switzerland with a new mechanism for giving innovative medicinal products the fastest possible route to market after only a short development time. Under the temporary authorisation procedure, the submitted clinical documentation does not have to be as complete as for a normal procedure. Temporary authorisation is limited to two years. If the conditions are met during this period, a temporary authorisation can be transformed into an ordinary authorisation. According to Art. 18 TPLO, a medicinal product may be temporarily authorised if: • it serves to identify, prevent or treat a disease that could lead to serious invalidity, cause severe suffering possibly resulting in death, or swiftly result in the death of a patient; • no alternative and equivalent medicinal product is authorised or available in Switzerland; • its use is likely to deliver major therapeutic benefit; • the applicant is likely to be able to supply the necessary data in due course; • it would take so long to compile all the required data, and to process and evaluate that data under an ordinary authorisation procedure, that irreversible damage would ensue or be aggravated, or severe suffering would result for the patient. The temporary authorisation procedure was devised to give patients get rapid access to highly promising medicinal products that meet the legal requirements. It follows similar lines to Swissmedic’s successfully established fast-track authorisation procedure, which is in itself very fast by international standards. The option of temporary authorisation is only available for human medicinal products icontaining new active substances. Temporary authorisation is contingent on the timely fulfilment of conditions. These conditions generally involve submitting the results of ongoing clinical trials.
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: 17 Autologous transplant products T
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 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
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Standards 69 Pharmacopoeia The phar
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Penal law 71 Investigative measures
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Penal law 73 Decisions / verdicts b
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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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