New Product Registrations
New product registration is required by Regulatory Agencies and Boards of Health for any new medicinal product before it can be marketed, and a form of registration is required before clinical trials may be conducted.
This is needed before the manufacturer or potential marketeer can test its diagnostic or therapeutic potential in human subjects.
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. This 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 conducts an investigation, 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 situation that does not allow time for submission of a formal IND in accordance with 21CFR.
• 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, whilst the FDA performs a safety evaluation before clinical studies may be initiated.
Clinical Trials Authorisation (CTA) (UK)
A CTA is required to be filed with the UK’s MHRA. The MHRA’s 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. This is granted in the form of a Clinical Trials Authorisation (CTA) and the content and level of detail is similar to that of an IND. Clinical Trials exemption holders (CTX, DDX or CTMP) and clinical trial certificate holders were notified in March 2004 that all current exemptions or certificates would roll over into CTAs.
How Woodley BioReg can help with IND application and CTA
Woodley BioReg supports clients conducting, and planning to conduct, clinical trials in Europe and the USA, through a compilation of documentation and IND / CTA submissions, advice on regulatory strategies and project planning and management.
Please contact Woodley BioReg for more advice and information on Clinical Trial Research and IND applications.