Cell and gene therapy products in Malaysia: a snapshot of the industry's current regulation preparedness

Author:

Loh Evelyn Yun Xi,Goh Pick Sim,Mannan Amirul Mohd Mahfuz,Mohd Sani Noraisyah,Ab Ghani Azizah

Funder

Ministerio de Sanidad, Consumo y Bienestar Social

Department of Culture and the Arts, Government of Western Australia

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics(clinical),Oncology,Immunology,Immunology and Allergy

Reference23 articles.

1. Regulatory Oversight of Cell and Gene Therapy Products in Canada;Ridgway,2015

2. Propelling Healthcare with Advanced Therapy Medicinal Products: A Policy Discussion;Horgan;Biomed Hub,2020

3. Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs) in Malaysia. https://www.npra.gov.my/index.php/en/guideline-bio/1533-guidance-document-and-guidelines-for-registration-of-cell-and-gene-therapy-products-cgtps-in-malaysia.html, [accessed 19 March 2021].

4. Approved Cellular and Gene Therapy Products. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products. [accessed 19 March 2021].

5. Technology forecast: advanced therapies in late clinical research, EMA approval or clinical application via hospital exemption;Eder;J Mark Access Health Policy,2019

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