By analogy with the procedure for orphan drugs, Swissmedic is streamlining the review procedure for authorisation applications relating to medicinal products authorised in the EU or the USA for the prevention of communicable diseases that can cause serious harm or prove fatal.
Change in the authorisation practice with regard to innovative human medicinal products for the prevention of communicable diseases
Application of Art. 13 TPA – streamlining of the review procedure for specific medicinal product categories on request
Swissmedic is broadening the criteria for the application of Article 13 TPA for innovative human medicinal products with new active substances (NAS) which are indicated for the prevention of a communicable disease and have already been authorised by the EU Commission or the US FDA. Provided the proposed indication is identical to the indication approved by the reference authority, Swissmedic can, if requested, scale back its own scientific review accordingly as of 1 January 2020.
In connection with discussions on improving the supply of medicines in Switzerland, Swissmedic (in consultation with relevant stakeholders within its jurisdiction) has examined whether – and, if so, how – foreign authorisation decisions can be taken into account more broadly without jeopardising patient safety.
As of 1 January 2020, the application of Art. 13 TPA will be extended subject to certain conditions. This reduces the work involved in submitting applications for new authorisations or additional indications relating to medicinal products that are indicated for the prevention of communicable diseases (e.g. vaccines) in Switzerland.
If requested, Swissmedic may – as is already the case for orphan drugs – scale back its own review procedure by relying on corresponding foreign review results, provided:
- the medicinal product has been authorised by the European Commission or the US FDA
- the review concerns a human medicinal product with new active substances (NAS) indicated for the prevention of a communicable disease that can lead to serious harm or serious suffering with a potentially fatal outcome, and
- the proposed indication is identical to the indication approved by the reference authority.
Even if there is only a limited connection between the authorisation and the availability of a medicinal product, this broader application of Art. 13 TPA will help improve primary prevention and thereby make an important contribution to the protection of public health.