Regulatory modification and collaboration between international regulatory agencies and the private

19/06/2020
          In March 2019, the Singapore Parenteral Drug Association (PDA) meeting focused on the development of "Advanced Therapy Medicinal Products (ATMPs)." One of the presenters predicted that the growth of ATMPs there would exceed over 900 percent within 2019, and the growth rate would come from the development of cell therapy technology used in conjunction with medical tools.

          Despite its high growth rate, the deployment of ATMPs in medical treatments has been gradual because of its high development cost particularly research development and logistic costs. In consequence of ATMP’s product complexity, this cost factor might have caused a relatively small number of treatments and the return of investment was relatively low. However, the meeting participants pointed out that the advantages of slow deployment and improved safety standard regulations has fostered the adjustment of regulations to be consistent and updated with changes in the technology. Examples of important regulatory developments were the safety issue in the production and transportation of cells to prevent infection in the ATMPs production process, cell culture processes, use of film in packaging, and transportation. The regulations were aimed to reduce the adverse effects as well as provide guidance for the remedy of the side-effect of the treatment.
 
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