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The goal: Approval brings efficacy to patients

From idea to effective therapy (6/6)

From Idea to Patient Step V
The results of clinical studies are evaluated and submitted for review. After a thorough review, a regulatory authority can approve the new therapy for medical use

If the study results are positive, i.e. if the strict criteria regarding efficacy and safety are met, an application for marketing authorization (approval) of the drug is submitted to the responsible health authority. 

"A marketing authorization application is very comprehensive. The results of all studies conducted, the exact composition, the manufacturing process and the quality controls are presented in it," explains Martina Schneider, who is responsible for the therapeutic area Hematology at the Global Regulatory Affairs department. Global Regulatory Affairs ensures that the company supplies products that meet the regulatory requirements of the countries where they are approved, are safe and make a valuable contribution to public health and welfare.

"Only after this approval does the drug enter the market. Commercial production and marketing will be handled by the relevant CSL business units specializing in this area," says Martin Broder. 

Nevertheless, the tasks of R&D do not stop after a product has been launched on the market. "We monitor the use of our drugs and are constantly developing them for the benefit of patients," says Wencke Maeder-Wotruba. She heads a product strategy team for the hematology therapeutic area. 

" Easier application, lower dosage or expansion of the patient group are just a few examples of what is being pursued after approval. "

Wencke Maeder-Wotruba, Global Product Lead Immunology

Read more about R&D's post-approval responsibilities here.  

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