4. Regulatory Requirements Flashcards
What is a CTA?
Clinical Trial Application
ICH-GCP means?
International Council for Harmonization-Good Clinical Practices
What must Medicine Regulatory Authorities (MRAs) and Institutional Review Boards (IRBs) ensure before participants enrollment into a clinical trial? (3)
The safety, quality and efficacy of the proposed clinical trial
When can a clinical trial start?
Once the country specific MRA (there can be more than one) as well as the IRB have approved of it
Who enforces the regulatory requirements?
The Country Specific MRA
What does the Common Technical Documentation (CTD) do?
Standartizes the format of a submission
How is a CTD generally organised? (5)
Into 5 Modules.
- Administration
- Overall Quality
- Quality Data
- Nonclinical Study Reports
- Clinical Study Reports
Who is the main regulatory body for Clinical Trials in the United States?
Food and Drug Administration (FDA)
Who are the two main regulatory body for Clinical Trials in the European Union?
- European Agency for the Evaluation of Medicine Products (EMA)
- European Member State Medicine Regulator
Who is the main regulatory body for Clinical Trials in China?
China Food and Drug Administration (CFDA)
Who are the three main regulatory body for Clinical Trials in India?
- Central Drugs Standard Control Organization Office of Drugs Controller General of India (DCGI)
- Indian Council of Medical Research (ICMR)
- Central Drugs Standard Control Organization (CDSCO)
Who is the main regulatory body for Clinical Trials in the UK?
Medicine and Healthcare Products Regulatory Agency (MHRA)
Who is the main regulatory body for Clinical Trials in Australia?
Therapeutic Goods Administration (TGA)
Who are the two main regulatory body for Clinical Trials in South Africa?
- Medicine Control Council (MCC)
2. Department of Health (DoH)
What is the guiding legislation in the US? (4)
Food, Drug and Cosmetic Act, 21 USC Section 355/371 (2012)
Public Health Service Act 42 USC Section 262 (1998)
FDA Administration Amendments Act 801
Food, Drug and Cosmetic Act, 21 USC Section 360 (2012)
What is the guiding legislation in the EU? (7)
Directive 2001/20 EC (Clinical Trials Regulation EU No 536/2014)
Directive 2001/83/EC
Directive 2005/28/EC
Regulation No. 536/2014
Directive 93/42/EC
Directive 98/79/EC
Directive 2007/47/EC
What does an IRB / IEC consist of ordinarily?
Physicians, Researchers and member of the community
What are the 3 steps necessary to fullfill to start a clinical trial in the EU?
- Obtain EudraCT Number
- Submit IMPD via CESP
- Get the go from authorities
Which authorities have to approve a Clinical Trial in Europe before it can start enrollment? (3)
- IRB
- National MRA
- Registered Ethics Committee
What are the 4 common steps worldwide to start a CT?
- MRA approval
- IRB / IEC approval
- Approval from the site
- Registration in national database / registry
