What is it? Why is it important?

Pre-clinical research and clinical studies provide findings (e.g. inventions) that lead to new products. These products are intended for human health, including the prospect of gain (e.g. financial, reputation, awards).

A clinical study per se does not suffice to patent an invention. But based on proof of safety and efficacy, its data can be used to complete a patenting dossier (e.g. a patent is a licence conferring rights for a set period time that excludes others from making, using or selling the invention).

An applicant who wants to protect or patent an invention, requires that the invention is:

  • New and previously undisclosed
  • Not obvious for an expert in the field
  • Able to be produced within an industrial setting

What do I need to do?

To acquire a marketing authorisation for drugs, the applicant must:

  • Complete a Marketing Authorisation Application (MAA)
  • Submit the application dossier to applicable competent authorities (e.g. Swiss and EU websites)
  • Patent the product in order to protect the product against copying
  • Provide authorities with evidences of product efficacy, safety, coequality or even superiority compared to potentially competing products
  • Receive applicable authorisations from each area of interest, valid only in its respective territories

Only after authorities approve the product can it be sold on the open market.

More

For a given product, other criteria and considerations may decide whether to submit a MAA (e.g. robustness of the product business plan, return on investment, production capacities).

A marketing authorisation from the European Commission is valid for all EU countries including Iceland, Lichtenstein and Norway.

Countries or regions have their own laws and procedures for issuing licences. Without a patent, licence, or production-secret, anyone can copy an invention.

Prior to sharing data, material, or any relevant information, implement and sign a:

  • Confidentiality Disclosure Agreement (CDA) between involved parties
  • Data Transfer Agreement (DTA) or Material Transfer Agreement (MTA) for the transfer of data or material

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

EMA - see in particular

  • Human regulatory / marketing authorisation

Swissmedic – see in particular

  • Human medicines / Authorisation / New authorisation / Overview 2021 / Authorisation of human medicinal products
Abbreviations
  • CDA – Confidentiality Disclosure Agreement
  • CTU – Clinical Trials Unit
  • DTA – Data Transfer Agreement
  • EU – European Union
  • EMA – European Medicines Agency
  • MAA – Marketing Authorisation Application
  • MTA – Material Transfer Agreement
Concept ↦ Ethics and Laws ↦ Research Aim ↦ Marketing Products
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Concept ↦ Ethics and Laws ↦ Research Aim ↦ Marketing Products

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