Advanced Therapy Products

Advanced therapies (cell, tissue and gene therapy products or regenerative medicine products) hold the promise to treat and cure medical conditions and diseases that currently have limited or no effective therapeutic options. Both the technical and regulatory sciences are rapidly evolving with many economies establishing a comprehensive regulatory framework that will be pro-innovation yet safeguard public health and safety. The goal of the PWA is to facilitate and implement strategies to stimulate and promote prospective regulatory convergence in applying scientific principles and best practices to ensure and enhance the safety, quality and efficacy of advanced therapy product development throughout the product life cycle.

CO-CHAMPIONS

  • Health Sciences Authority (HSA), Singapore
  • US Food and Drug Administration (US FDA), United States

SUB-CHAMPION

  • Biotechnology Innovation Organization (BIO)

The PWA Co-Champions and Sub-Champion’s contacts can be found here.

CENTERS OF EXCELLENCE

  • Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore
  • Northeastern University (NEU), United States 
  • United States Pharmacopeia (USP), United States

The respective Centers of Excellence’s contacts and website links can be found here.

ACTIVITIES

 2021

MAY

APEC Center of Excellence established

United States Pharmacopeia (USP), United States

MAR

APEC Pilot CoE Training (Virtual)

United States Pharmacopeia (USP), United States

2020

JUN

APEC Pilot Center of Excellence established

United States Pharmacopeia (USP), United States

2019

OCT

APEC Center of Excellence established

Northeastern University (NEU), United States

AUG

APEC Center of Excellence established

Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore

JUL

APEC Pilot CoE Training (United States)

Northeastern University (NEU), United States

2018

JUL

APEC Pilot CoE Training (Singapore)

Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore

FEB

APEC Pilot Center of Excellence established

Northeastern University (NEU), United States

2017

JUL

APEC Pilot CoE Training (Singapore)

Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore

2016

AUG

APEC Pilot Center of Excellence established

Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore

Establishment of Advanced Therapies PWA