Information on changes to the following guidance documents are provided below:
- Time limits for authorisation applications
- Temporary authorisation of human medicinal products
- Meetings for applicants for authorisation procedures
- Variations and extensions HAM
Changes to the Guidance document Time limits for authorisation applications
The international Project Orbis and Access Consortium procedures have been added to the updated Guidance document Time limits for authorisation applications (Ver 7.0) which is effective from 1 June 2024.
- The overview of time limits has also been restructured so that it is clearer which procedures are fast-tracked.
- The integration of international procedures into the Guidance document includes a revision of section 5.1 “Procedure period”.
- A new subsection 5.1.3 “International procedures” has been added.
- The time limits for international procedures have also been added to the overview of time limits in Annex 1.
- The overview of time limits has also been restructured to organise the procedures by standard time limits, fast-track time limits and by national and international procedures.
- Various editorial changes have also been made as part of the update to the Guidance document.
The revised Guidance document Time limits for authorisation applications is valid with effect from 1 June 2024.
Source: Swissmedic
Changes to the Guidance document Temporary authorisation of human medicinal products
Medicinal products for identifying, preventing or treating a disease that is life-threatening or could result in disability can be authorised temporarily by Swissmedic.
- Application of the fast-track procedure for temporary authorisations enables medicinal products with a major therapeutic benefit to be made available to affected patients more quickly.
- This revision of the scope for temporary authorisations makes these possible for human medicinal products with a known active substance, provided that all criteria according to Art. 9a TPA in conjunction with Art. 18 TPLO are met.
- The restriction that the innovative aspect of the new authorisation with known active substance must be an indication extension has been removed from the scope.
- The revised Guidance document Temporary authorisation for human medicinal products (Ver 15.0) is effective from 1 June 2024.
Source: Swissmedic
Changes to the Guidance document Meetings for applicants for authorisation procedures
As part of a pilot, Swissmedic is now offering Preliminary Decision Clarification Meetings for applications for new authorisation or variation of the indication of medicinal products for human use with a new active substance (NAS).
- During the Preliminary Decision Clarification Meeting, applicants have an additional opportunity for dialogue with Swissmedic to clarify any questions or anything that is unclear regarding the preliminary decision.
- Further information on how to request a pilot Preliminary Decision Clarification Meeting and its structure can be found in the Annex to the Guidance document Meetings for applications for authorisation procedures
- Swissmedic has revised the Guidance document Meetings for applications for authorisation procedures, providing further clarification, particularly regarding the content of the Pipeline Meeting, and making editorial changes.
- The revised Guidance document Meetings for applications for authorisation procedures (Ver 3.0) is effective from 1 June 2024.
Source: Swissmedic
Changes to the Guidance document Variations and extensions HAM
The rules on issuing new packaging codes are being simplified, meaning that Swissmedic will issue significantly fewer new codes in the future.
- This simplification will apply to applications received by Swissmedic from 1 June 2024.
- Section 9.3 Issuing of a new packaging code in the Guidance document (WL) Variations and extensions HAM has been revised accordingly.
- In addition, redundancies in sections 9.1 Issuing of a new authorisation number and 9.2 Issuing of a new dosage strength number have been deleted.
- With the increase of the flat fee for indication extensions to CHF 25,000 and lowering of the maximum cost cap to CHF 30,000, Swissmedic will in future not subsume fees for multiple applications.
- Numbers 7.8, 7.9 and 7.14 in the document Questions and answers on variations and extensions HMP have been revised or deleted accordingly.
- It has been clarified in section 1.1.7 Multiple application of the Guidance document Variations and extensions HAM that each variation must be ticked individually in the corresponding application submission form.
- The revised Guidance document Variations and extensions HAM and the revised document Questions and answers on variations and extensions HMP (Ver 9.0) is effective from 1 June 2024.
Source: Swissmedic