THE GLOBAL GUIDE
How will this guide help me?
Responsible for establishing a compassionate use or expanded access program?
You will need to know the answers to the following questions:
- What is the appropriate regulatory agency for each country?
- Does the country allow for compassionate use or expanded access programs?
- What type of program is allowed?
- What are the regulations and laws for each country?
- What are the source documents guiding the regulations?
- How can a sponsor or clinician initiate a request for compassionate use?
- What are the roles and responsibilities for sponsor, physician, pharmacist?
- What are the pharmacovigilance requirements for each mechanism ?
- What label content is required and what language(s) are acceptable for each regulatory mechanism ?
- Can a sponsor charge for the therapy?
- Are there any fees for establishing a program?
As consultants with decades of experience we’ve been researching the answers to these critical questions for over 4 years – consulting Ministry of Health websites, thought leaders, MOH representatives and putting their information together with our own global expertise in to this one stop resource. We’ve evaluated over 150 countries and around 60 of them are in this first version of the guide.