Market

Health Authority

Regulations/Guidelines

Approval Timeline

Australia

Therapeutic Goods Administration
Special Access Scheme
  • Categories A and C: Notify TGA within 28 days of the unapproved therapeutic goods being supplied
  • Category B: Commonly requested products (online submission) 2-3 working days but may be extended for products not previously requested under SAS
China
National Medical Products Administration or Provincial Government authorized by the State Council
Drug Administration Law (DAL) effective December 1, 2019

Regulations for the Implementation of the Drug Administration Law, draft version on May 9, 2022

State Council’s Decision on Temporary Adjustment on the Implementation of Relevant Provisions of the “Regulations for the Implementation of Drug Administration Law” in Hainan Boao Lecheng International Medical Tourism Pilot Zone, December 21, 2018

Work Plan for the Regulatory Innovation and Development of Drugs and Medical Devices in Guangdong-Hong Kong-Macau Greater Bay Area, issued by the State Administration of Marketing Regulation on November 25, 2020

Work Plan for Temporary Import of Drugs Urgently Needed in Clinical Practice, issued by the National Health Commission on June 29, 2022

Not specified in the DAL or (Draft) Regulations for the implementation of DAL

Hong Kong

Department of Health
Named patient program
No timeline specified
India
Central Drugs Standard Control Organization (under Ministry of Health and Family Welfare)
Compassionate use of new drug
Application reviewed within 30 days
Indonesia
National Agency of Drug and Food Control
(NADFC/BPOM)

Ministry of Health of the Republic of Indonesia (MoH)

Special Access Scheme
  • NADFC will issue import license for the unapproved biological product no later than 10 working days from receipt of application
  • MoH will issue the import license for the unapproved drug according to its urgency (Category A or B)
Japan
Ministry of Health, Labour and Welfare
Expanded Access Clinical Trial (conducted on ethical grounds)
No timeline specified
Malaysia
Pharmaceutical Services Programme
Named Patient Program
Review and approval will take approximately two to four weeks
New Zealand
Medsafe
Use of Unapproved Medicines and Unapproved Use of Medicines
No prior approval required for medical practitioners. Suppliers of unapproved medicines must notify Medsafe as soon as practical after the end of every month in which the medicine was supplied.
Philippines
Philippines Food and Drug Administration
Compassionate Special Permit
Approval time for single patient access varies, but FDA can complete the paperwork in two to three days for emergencies.
Singapore
Health Science Authority
Special Access Route
Target turnaround time of 14 working days, excluding stop-clock time
South Korea
Ministry of Food and Drug Safety
Treatment use of an investigational new drug
or
Emergency use of an investigational new drug
  • 7 days (for individual patient)
  • 30 days (for more than two patients)
Taiwan
Taiwan Food and Drug Administration
Regulations for Approval of Specific Medical Products’ Manufacturing or Importing as a special case
No timeline specified
Thailand
Thailand Food and Drug Administration
Patient Use Program
No timeline specified

Vietnam

Drug Administration of Vietnam
Decree 54/2017/ND-CP, Article 68, drug import license for special therapeutic demand
Import license for special purposes will be processed within 60 days
Market

Australia

Health Authority

Therapeutic Goods Administration
Regulations/Guidelines
Special Access Scheme

Approval Timeline

  • Categories A and C: Notify TGA within 28 days of the unapproved therapeutic goods being supplied
  • Category B: Commonly requested products (online submission) 2-3 working days but may be extended for products not previously requested under SAS
Market
China
Health Authority
National Medical Products Administration or Provincial Government authorized by the State Council
Regulations/Guidelines

Drug Administration Law (DAL) effective December 1, 2019

Regulations for the Implementation of the Drug Administration Law, draft version on May 9, 2022

State Council’s Decision on Temporary Adjustment on the Implementation of Relevant Provisions of the “Regulations for the Implementation of Drug Administration Law” in Hainan Boao Lecheng International Medical Tourism Pilot Zone, December 21, 2018

Work Plan for the Regulatory Innovation and Development of Drugs and Medical Devices in Guangdong-Hong Kong-Macau Greater Bay Area, issued by the State Administration of Marketing Regulation on November 25, 2020

Work Plan for Temporary Import of Drugs Urgently Needed in Clinical Practice, issued by the National Health Commission on June 29, 2022

Approval Timeline

Not specified in the DAL or (Draft) Regulations for the implementation of DAL
Market
Hong Kong
Health Authority
Department of Health
Regulations/Guidelines
Named patient program

Approval Timeline

No timeline specified
Market
India
Health Authority
Central Drugs Standard Control Organization (under Ministry of Health and Family Welfare)
Regulations/Guidelines
Compassionate use of new drug

Approval Timeline

Application reviewed within 30 days
Market

Indonesia

Health Authority
National Agency of Drug and Food Control
(NADFC/BPOM)

Ministry of Health of the Republic of Indonesia (MoH)

Regulations/Guidelines
Special Access Scheme

Approval Timeline

  • NADFC will issue import license for the unapproved biological product no later than 10 working days from receipt of application
  • MoH will issue the import license for the unapproved drug according to its urgency (Category A or B)
Market
Japan
Health Authority
Ministry of Health, Labour and Welfare

Pharmaceuticals and Medical Devices Agency

Regulations/Guidelines
Expanded Access Clinical Trial (conducted on ethical grounds)

Approval Timeline

No timeline specified
Market
Malaysia
Health Authority
Pharmaceutical Services Programme
Regulations/Guidelines
Named Patient Program

Approval Timeline

Review and approval will take approximately two to four weeks
Market
New Zealand
Health Authority
Medsafe
Regulations/Guidelines
Use of Unapproved Medicines and Unapproved Use of Medicines

Approval Timeline

No prior approval required for medical practitioners. Suppliers of unapproved medicines must notify Medsafe as soon as practical after the end of every month in which the medicine was supplied.

Market
Philippines
Health Authority
Philippines Food and Drug Administration
Regulations/Guidelines
Compassionate Special Permit

Approval Timeline

Approval time for single patient access varies, but FDA can complete the paperwork in two to three days for emergencies.
Market

Singapore

Health Authority

Health Science Authority
Regulations/Guidelines
Special Access Route

Approval Timeline

Target turnaround time of 14 working days, excluding stop-clock time
Market
South Korea
Health Authority
Ministry of Food and Drug Safety
Regulations/Guidelines
Treatment use of an investigational new drug
or
Emergency use of an investigational new drug

Approval Timeline

  • 7 days (for individual patient)
  • 30 days (for more than two patients)
Market
Taiwan
Health Authority
Taiwan Food and Drug Administration
Regulations/Guidelines

Regulations for Approval of Specific Medical Products’ Manufacturing or Importing as a special case

Approval Timeline

No timeline specified
Market
Thailand

Health Authority

Thailand Food and Drug Administration
Regulations/Guidelines
Patient Use Program

Approval Timeline

No timeline specified

Market

Vietnam

Health Authority

Drug Administration of Vietnam
Regulations/Guidelines
Decree 54/2017/ND-CP, Article 68, drug import license for special therapeutic demand

Approval Timeline

Import license for special purposes will be processed within 60 days