Sakigake Designation - Pharma

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Relevant Publications

Regulatory Issues: PMDA - Review of Sakigake Designation Products: Oncolytic Virus Therapy with Delytact Injection (Teserpaturev) for Malignant Glioma.

Issue Release: 2023

[PMDA\'s Initiatives to Encourage the New Drug Development for Rare Cancers].

Issue Release: 2023

Olipudase Alfa: First Approval.

Issue Release: 2022

The Qualitative Value of Facilitated Regulatory Pathways in Europe, USA, and Japan: Benefits, Barriers to Utilization, and Suggested Solutions.

Issue Release: 2021

Achievements and challenges of the Sakigake designation system in Japan.

Issue Release: 2021

[Pharmacological and clinical study results of trastuzumab deruxtecan (T-DXd, ENHERTU)].

Issue Release: 2021

Breakthrough Therapy, PRIME and Sakigake: A Comparison Between Neuroscience and Oncology in Obtaining Preferred Regulatory Status.

Issue Release: 2020

[Pharmaceutical approval process of drugs for hematological malignancies: current situations in Japan].

Issue Release: 2020

The Diagnostic Criteria 2020 for Triglyceride Deposit Cardiomyovasculopathy.

Issue Release: 2020

Bardoxolone methyl: drug development for diabetic kidney disease.

Issue Release: 2020

Regenerative medicine regulatory policies: A systematic review and international comparison.

Issue Release: 2020

Considerations and Regulatory Challenges for Innovative Medicines in Expedited Approval Programs: Breakthrough Therapy and Sakigake Designation.

Issue Release: 2019

Promotion of Japan\'s participation in global clinical trials.

Issue Release: 2019

Breakthrough Therapy, PRIME and Sakigake: A Comparison Between Neuroscience and Oncology in Obtaining Preferred Regulatory Status.

Issue Release: 2019

Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan.

Issue Release: 2019

Current Trends in Clinical Development of Gene and Cellular Therapeutic Products for Cancer in Japan.

Issue Release: 2018

New Japanese Regulatory Frameworks for Clinical Research and Marketing Authorization of Gene Therapy and Cellular Therapy Products.

Issue Release: 2017

The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States.

Issue Release: 2016

Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan.

Issue Release: 2016

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