News from GMP Area

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“Annual Report 2016” of EMA indicates a positive trend for ATMP, 19th of June 2017

In the actual “Annual Report 2016” the EMA published, that the number of adopted recommendations for advanced therapy medicinal products (ATMP) increased continuously over the last 4 years and reached a peak in 2016.

ATMPs are defined as “advanced therapies, such as gene therapy, somatic cell therapy, and tissue engineering.”They have a big potential for treatment of diseases where conventional approaches are inadequate. ATMP developers have the opportunity to apply their draft opinion on ATMP application. Before the appropriate authority CHMP (Committee for Medicinal Products for Human Use) adopts a final decision, the brains trust of CAT (Committee for Advanced Therapies) is responsible to review the certification of quality and non-clinical data and provides scientific recommendations on the classification of ATMPs for assessing the quality, safety and efficacy of ATMPs.

In 2016, the number of ATMPs argued for recommendation increased from 31 to 87 in comparison to 2015. Thereby, the small and medium-sized enterprises (SME) represented a significant higher proportion than academia. All this leads to a situation that ATMP will have higher impact in medical treatment in the future.

 

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".