All new products are required to be registered by regulatory agencies and boards of health before it can be supplied for use. Similarly, a form of registration is required before clinical trials may be conducted. Such registration activities are mandatory before any studies on human subjects or patients can be considered.
Investigational New Drug (IND) application (USA)
An Investigational New Drug (IND) application is filed with the US FDA, for either commercial or research purposes, to enable early assessment and evaluation of potential new drugs. Filing an IND application triggers a change in legal status under the Federal Food Drug and Cosmetic Act and the target molecule becomes a new drug that is subject to specific requirements under the drug regulatory system.
Three types of IND currently exist:
- An investigator IND – submitted by a physician who both initiates and investigates, and under whose immediate direction the investigational drug is administered or dispensed.
- Emergency use IND – allowing the FDA to authorise use of an experimental drug in an emergency that does not allow time for submission of a formal IND in accordance with 21 CFR.
- Treatment IND – submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions.
All types of IND application must contain information in three broad areas:
Pharmacology and toxicology Studies – from the preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans
Manufacturing information – detailing the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product to ensure that the company can adequately produce and supply consistent batches of the drug.
Clinical protocols and investigator information – for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB,) and to adhere to the investigational new drug regulations.
Once the IND application has been submitted there is a 30-calendar day wait period whilst the FDA performs a safety evaluation before clinical studies may be initiated.
Clinical Trials Authorisation (CTA) (EU and UK)
An Investigational Medicinal Product Application (IMPD) and / or Clinical Trials Authorisation (CTA) application is required to be filed with the EMA / UK’s MHRA. The Clinical Trials Directive states that clinical trials of medicinal products in human subjects require authorisation by the competent authority and a favourable opinion by an ethics committee before a study may commence. Clinical studies may only commence following the receipt of an approval from the licensing authority.