Authorisations of human medicinal products with a new active substance and additional indications 2024
46 human medicinal products with new active substances authorised
Swissmedic authorised 46 human medicinal products with new active substances for the Swiss market in 2024 – an increase of 12% compared to the previous year.
This report summarises the most important information on these new authorisations as well as on the approved additional indications.
It provides a compact overview of the authorisation procedures used (including the reliance procedure, fast-track procedure and international procedures under Access and Orbis) as well as of the duration of the procedures and indications.
Swissmedic is also participating in two benchmarking studies conducting an international analysis of authorisation times with leading partner authorities. The findings of these studies will be published during the course of 2025.
Archive
Overview of new authorisations 2023 - 2019
2023
Authorisations of human medicinal products with a new active substance and additional indications 2023
41 human medicinal products with new active substances authorised
Overview of new authorisations 2023
In 2023, Swissmedic, the Swiss Agency for Therapeutic Products, authorised 41 medicinal products with new active substances for the Swiss market.
The overview shows the indications and the type and duration of the authorisation procedures. Swissmedic is also participating in two benchmarking studies to compare the authorisation times with those of the leading partner authorities. The results of these studies will be published during the course of 2024.
The following overview shows which procedures the applicants used, how long the authorisation processes lasted, and for which indications the medicines were authorised.
2022
Authorisations of human medicinal products with a new active substance and additional indications 2022
47 human medicinal products with new active substances authorised
Overview of new authorisations 2022
In 2022, Swissmedic, the Swiss Agency for Therapeutic Products, again reviewed and authorised for the Swiss market more medicinal products with new active substances than in previous years.
The increased time needed for the reviews compared to the preceding year is primarily attributable to applications that were submitted and processed during the intensive pandemic years 2020/2021 and completed in 2022. During this time, applications for medicines and vaccines against the coronavirus SARS-CoV-2 were prioritised over other innovative new applications.
The overview shows the indications and the type and duration of the authorisation procedures. Swissmedic is also participating in two benchmarking studies to compare the authorisation times with those of the leading partner authorities. The results of these studies will be published during the course of 2023.
The following overview shows which procedures the applicants used, how long the authorisation processes lasted, and for which indications the medicines were authorised.
2021
Authorisations of human medicinal products with a new active substance and additional indications 2021
Overview of new authorisations 2021
In the second year of the pandemic, Swissmedic again assessed a record number of medicinal products with new active substances and authorised them for distribution on the Swiss market. In this brochure you can see which procedures the applicants used, how long the authorisation processes lasted, and for which indications the medicines were approved.
2020
Authorisation of human medicinal products with new active substances and of additional indications 2020
New authorisations – Overview 2020
In 2020, despite the extraordinary amount of work generated by the pandemic, Swissmedic assessed a record number of medicinal products with new active substances and authorised them for distribution on the Swiss market. In this brochure you can see which procedures the applicants used, how long the authorisation processes lasted, and for which indications the medicines were approved.
2019
Human medicinal products with a new active substance authorised in 2019
| Authorisation procedure |
Approvals |
Rejections |
Withdrawals |
Total |
| NA NAS Standard |
20 |
2 |
3 |
25 |
| NA NAS FTP |
2 |
0 |
0 |
2 |
| NA NAS as per Art. 13 TPA |
3 |
0 |
0 |
3 |
| NA NAS PPN |
4 |
0 |
0 |
4 |
| Total |
29 |
2 |
3 |
34 |
FTP: Fast-track authorisation procedure
TPA: Therapeutic Products Act
NA NAS: New application for a new active substance
PPN: Procedure with prior notification
In 2019, Swissmedic issued decisions authorising 34 human medicinal products with new active substances. In 18% of cases, a fast-track authorisation procedure was used (FTP/PPN), and in 9% of cases, Swissmedic based its decision upon the assessment of a foreign regulatory authority with comparable medicinal product control (Art. 13 TPA).
One in three of the newly authorised innovative medicinal products is used in cancer treatment; thus the trend of previous years was continued in 2019.
Product name
|
Indication |
| Alimentary tract and metabolism |
| Procysbi |
Nephropathic cystinosis |
| Blood and blood-forming organs |
| Cablivi |
Acquired thrombotic thrombocytopenic purpura (aTTP) |
| Jivi |
Haemophilia A |
| Esperoct |
Haemophilia A |
| Monofer |
Iron deficiency |
| Takhzyro |
Preventing attacks of hereditary angioedema |
| Dermatologicals |
| Dupixent |
Moderate to severe atopic dermatitis |
| Anti-infectives for systemic use |
| Zavicefta |
Infections |
| Pifeltro |
HIV infection |
| Biktarvy |
HIV infection |
| Vaxelis |
Primary and booster vaccination in infants and toddlers from the age of six weeks to four years (before the fifth birthday) against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by haemophilus influenzae type-b (Hib). |
| Antineoplastic and immunomodulating agents |
| Mylotarg |
Acute myeloid leukaemia |
| Mektovi |
Melanoma with BRAF V600 mutation |
| Braftovi |
Melanoma with BRAF V600 mutation |
| Vizimpro |
Advanced or metastatic non-small cell lung cancer (NSCLC) |
| Verzenios |
Locally advanced or metastatic HER2-negative breast cancer |
| Talzenna |
Locally advanced or metastatic HER2-negative breast cancer with a germline BRCA mutation |
| Erleada |
Non-metastatic, castration-resistant prostate cancer (NM-CRPC) |
| Skyrizi |
Moderate to severe plaque psoriasis |
| Ilumetri |
Moderate to severe plaque psoriasis |
| Yescarta |
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Primary mediastinal large B-cell lymphoma (PMBCL) |
| Musculoskeletal system |
| Spherox |
Symptomatic articular cartilage defects in the femoral condyles and patella |
| Nervous system |
| Ajovy |
Preventive treatment of migraines |
| Emgality |
Preventive treatment of migraines |
| Fampyra |
Multiple sclerosis |
| Onpattro |
Hereditary transthyretin amyloidosis (hATTR amyloidosis) |
| Radicava |
Amyotrophic lateral sclerosis (ALS) |
| Respiratory system |
| Respirationstrakt |
Cystic fibrosis |
| Miscellaneous |
| Lutathera |
Metastatic or non-resectable, progressive, well-differentiated (G1 and G2) somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP‑NETs) |
