Expiry dating of investigational medicinal products
There are clear differences in the development, review, and commercialization processes of the biologic and the device.When these two cultures come together in a combination product, developers and reviewers must find ways to address the design controls and risk management processes of both the biologic and device, and knit them into a single entity with supporting product approval documentation.[B2] Are non-clinical safety/toxicology studies required to be conducted in compliance to GLP standards?[B3] Are there any regulatory requirements for clinical trials involving radiopharmaceuticals?[B4] What kind of preclinical data is required to support clinical trials of cell, tissue and gene therapy products (CTGTP)?[B5] Are there any additional dossier requirements for submission of cell, tissue and gene therapy product (CTGTP) clinical trials?[A11] Are there any fees for the submission of clinical trial application to HSA?
Despite an admirable cooperation between industry and FDA in recent years, unique product configurations and design features have resulted in review challenges.
[A5] For how long is a Clinical Trial Authorisation (CTA), Clinical Trial Notification (CTN) or Clinical Trial Certificate (CTC) valid?
[A6] What are the subsequent applications required to be submitted to HSA following receipt of the authorisation (for CTA), acceptance of notification (for CTN) or approval (for CTC) by HSA?
Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery.
For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products.