News from GMP Area

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New action plan to foster development of advanced therapies, 30th of October 2017

The european commission's directorate-general for health and food safety (DG Sante) and the european medicines agency (EMA) in collaboration with the member states competent authorities published a joint action plan to foster the development and authorization of advanced therapy medicinal products (ATMPs). The main aim is to streamline procedures and better address the specific requirements of ATMP developers. The plan published contains 19 actions in different areas, some already in place and others new.

Examples of upcoming actions include:

  • European commission guideline on good manufacturing practice for ATMPs, to reduce the administrative burden and adapt the manufacturing requirements to the specific characteristics of ATMPs
  • New EMA scientific guidelines on ATMPs, including investigational ATMPs, to clarify regulatory expectations

For more information about thenew action plan for ATMPs look at the publication of the EMA.

 

Further information


 
Dr Claudia Papewalis is giving a GMP for ATMP training

GMP for ATMPs

If you want to know more about the regulatory requirements requested for manufacturing ATMPs, contact our experts or take part at one of our internal GMP training courses.

A scientist is looking at t-cells visible at a computer screen

GMP-compliant manufacturing process

Valicare supports start-ups like polybiocept in transferring cell-culturing methods developed at the laboratory into a GMP-compliant manufacturing process. Check the press release and get an overview about our GMP for ATMP services.

cell culture, ATMPs

„Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products”

On 22th of November 2017 the European Commission adopted the "Guidelines on Good Manufacturing Practices (GMP) specific to Advanced Therapy Medicinal Products".