Owing to the revision of the TPA and the corresponding implementing ordinances (Therapeutic Products Ordinance Package IV), Swissmedic has adapted the specification documents and forms for authorisation applications.
With the ordinary revision of the TPA (Stage 2, TPA2), the legislator aims to improve the public access to medicines and the general environment for biomedical research and industry. The Federal Council referred the Dispatch on the Revision of the Therapeutic Products Act to Parliament on 7 November 2012. The National Council and Council of States adopted the core elements of the Federal Council's draft, with certain changes, and approved the revised Therapeutic Products Act in the final vote on 18 March 2016.
Because of the numerous amendments to the Act, the relevant ordinances also need to be comprehensively amended. Individual provisions (national recommendations on dosages of paediatric medicinal products, definitive arrangements for medicinal products approved by cantons) and the corresponding ordinance terms already entered into force at the beginning of 2018. The Medicinal Products Licensing Ordinance (MPLO) is being revised in the context of the drafting of the provisions for implementing the Medicrime Convention.
The latest revision of the Act and the newly proposed amendments to the implementing regulations are aligned to the following aims:
Facilitating market access
Create new, simplified authorisation options for certain medicinal product categories (especially medicinal products authorised in an EU or EFTA country, medicinal products with traditional uses, medicinal products already approved in a canton, as well as various medicinal products used in complementary medicine)
simplify self-medication by modifying the allocation of the medicinal products to the different supply categories, and ease the supply requirements.
Improving drug safety
Tighten up and modernise market surveillance (introduce the pharmacovigilance plan, apply Good Vigilance Practice, increase the scope and define the reporting obligations in more detail)
improve the safety of medicinal products used in paediatrics (publish a directory for off-label dosage recommendations for the medicinal products used in paediatrics, establish new obligations and incentives for the pharmaceutical industry to promote the development of paediatric medicinal products)
define minimum requirements for the prescription of medicinal products.
Increase the scope of information published about the medicinal products submitted to Swissmedic for assessment and their authorisation holders (particularly publication of the assessment reports for human medicinal products with new active substances on which the authorisation decisions are based [SwissPAR])
clarify the arrangements regarding pecuniary benefits (integrity and transparency) and strengthen the implementation of these provisions as well as the obligation to pass on discounts in accordance with health insurance legislation
create an information system for monitoring the distribution and use of antibiotics and the antibiotic resistance situation in veterinary medicine.
Responsibilities when it comes to therapeutic product safety
Swissmedic is responsible for authorisation and issues relating to licensing. In questions on the legislative process at Federal Council level, the Federal Office of Public Health (FOPH) takes the lead. For questions concerning intellectual property rights, please contact the Swiss Federal Institute of Intellectual Property (IPI).
How does Swissmedic intend to handle the transition in application submission and processing resulting from the change in the law (transition from current therapeutic legislation to the new legal requirements of the revised TPA)?
The transition will take place under the principle that pending applications submitted before 31 December 2018 will be processed in accordance with the existing TPA (incl. enforcement). Applications submitted after 1 January 2019 will be subject to the new legislation and processed in accordance with the revised TPA (incl. enforcement). The same will apply to the fees charged.