Swissmedic. Medical search. Frequent questions

If approval bodies such as the US Food and Drug Administration and Switzerland's Swissmedic require further studies, that would add at least three months. (irishtimes.com)
Future efforts could also involve the EMA, Japan's Pharmaceuticals and Medical Devices Agency, and Switzerland's Swissmedic. (aacrjournals.org)
For this review, the FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, and Switzerland's Swissmedic. (ascopost.com)

The Swiss Agency for Therapeutic Products (Swissmedic) is the Swiss surveillance authority for medicines and medical devices, registered in Bern. (wikipedia.org)
The Federal Council has appointed Vincenza Trivigno to the Agency Council of the Swiss Agency for Therapeutic Products, Swissmedic, for the remainder of the 2014-17 period in office. (swissmedic.ch)
Octapharma today announced that the Swiss Agency for Therapeutic Products, Swissmedic, granted marketing authorization to its new fibrinogen concentrate product fibryga® for the treatment of congenital and acquired fibrinogen deficiencies. (octapharmausa.com)
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on the temporary authorization of human medicinal products. (ris.world)
SwissMedic, the Swiss Agency for Therapeutic Products, is a public institution of the Swiss government. (nai-online.com)
Prior to joining Sidley, Eva served with Swissmedic, the Swiss Agency for Therapeutic Products, as Deputy Head of the Legal Advice Department and as Legal Advisor to the agency's Digital Transformation Initiative SMC 4.0. (sidley.com)

Moreover, Swissmedic must be notified of all clinical studies conducted in Switzerland. (wikipedia.org)
The overview shows all manufacturers, importers and authorised representatives which are located in Switzerland or Liechtenstein and registered at Swissmedic. (opendata.swiss)

Swissmedic is a federal institution subject to public law and was created by the Federal Act on Medicinal Products and Medical Devices. (wikipedia.org)
When authorising new medicinal products, Swissmedic bases its decisions on internationally acknowledged criteria. (wikipedia.org)
The Swissmedic website for authorization of herbal medicinal products (HMPs) has been completely revised and updated. (gmp-compliance.org)

Swissmedic has temporarily authorised Comirnaty Bivalent Original / Omicron BA.1 (tozinameran / riltozinameran), containing messenger ribonucleic acid (mRNA) against two coronavirus variants. (swissmedic.ch)
The data currently available to Swissmedic regarding the recently submitted application for authorisation for the bivalent vaccine Comirnaty Original/Omicron BA.4-5 are not yet sufficient for a decision. (swissmedic.ch)
Following similar decisions by the American and European regulators, Swissmedic approved Pfizer/BioNTech's bivalent Comirnaty booster . (pharmaceutical-technology.com)

SEOUL, South Korea , Sept. 19, 2023 /PRNewswire/ -- Deep Bio, a leader in artificial intelligence (AI)-powered cancer diagnostics, announced today that it has obtained marketing authorization from Swissmedic for DeepDx Prostate, its AI-powered prostate cancer diagnostic software. (wreg.com)
Swissmedic is the Swiss regulatory authority responsible for the authorization and supervision of therapeutic products. (wreg.com)
In the document, Swissmedic outlines the process for seeking temporary authorization, a path to market that allows organizations to sell a medicine for up to two years despite lacking complete documentation. (ris.world)
During her 14 years at Swissmedic, she advised both internal and external stakeholders on all issues relating to the legal and regulatory framework regarding therapeutic products, including clinical trials, product authorization, licensing, market access and surveillance. (sidley.com)

The SwissMedic and the Federal Office of Public Health's websites express thoughts about medicines for children comparable to the justifications of US & EU pediatric laws [2, 3]. (smw.ch)

If the criteria for authorisation are fulfilled, Swissmedic grants the marketing authorisation, specifies the method of sale (on prescription only/dispensing point) and approves the information for healthcare professionals and the patient information. (wikipedia.org)

In addition to Swissmedic, Coartem Dispersible is approved by 17 regulatory authorities in Africa. (mmv.org)
Regulatory decisions by the US FDA, EMA and Swissmedic for select therapies from late September to October and the CMOs contracted to manufacture them. (pharmaceutical-technology.com)

According to Swissmedic, there are currently no national or international legal foundations for the inclusion of RWE in the authorisation procedure for therapeutic products. (walderwyss.com)

Swissmedic's seven-member Agency Council is responsible for the agency's strategic direction. (swissmedic.ch)

Any medical products for humans or animals need approval from Swissmedic to be brought on the Swiss market. (wikipedia.org)

Cerus Corporation (NASDAQ: CERS) is seeing a huge surge on news that Swissmedic has approved the use of platelet components treated with Cerus' INTERCEPT Blood System. (247wallst.com)

Referring to reports by the United States Food and Drug Administration (FDA), Swissmedic said the product could spread and lead to problems with swallowing and breathing if applied to the throat area. (swissinfo.ch)

The outstanding result of the clinical trial and the approval by Swissmedic is a great milestone for the company, as well as for the treating physicians, but most of all for the patients suffering from critical bleeding," Olaf Walter, Board Member said. (octapharmausa.com)

Among other things, it sets out the types of application for which Swissmedic currently takes RWE into account and the important aspects that applicants must pay particular attention to. (walderwyss.com)

Eva has represented Swissmedic as lead counsel in litigation before the Swiss Federal Administrative Court and the Swiss Federal Supreme Court. (sidley.com)

Eva brings a wealth of digital health and artificial intelligence experience, having previously served at Swissmedic as Deputy Head of the Legal Advice Department and as Legal Advisor to the agency's Digital Transformation Initiative. (sidley.com)

The Council heads up the Swissmedic Management Board, which is responsible for operational management. (swissmedic.ch)