With the evolution of products in the tissue regeneration arena, we are seeing a concomitant transition in the way the FDA intends to regulate these types of products and therapies.
Traditionally products derived from human sources such as amnion, chorion and amniotic fluid have been used for a variety of ailments including eye and orthopedic uses and happy regulated according to 21 CFR part 1271 and section 36 of the Public Health Act (PHA).
However, as various companies have developed products and formulations for these tissues and fluids, that has been an increased level of interest in whether processes used to make these preparations have altered the biological benefit of pharmacological function of the material. This then takes one into a new area of potentially altered or new products which are not totally “natural”, which questions that regulation under the good tissue practices regulations.
Some of these processes include variations in reagent treatments and/or the ability to freeze the material for long-term storage/shelf-life.
As a result of this, that is a definition that has been derived which categorizes how much a tissue can be manipulated before it might be altered, referred to as the minimum I manipulated definition. With this definition, material can still be regulated in accordance with good tissue practices. But outside of this, it will be required to conform to the stricter regulations associated for other (arguably more conventional) Biologics, which require full cGMP regulations under 21 CFR part 210/211 and series 600s for biologicals.
For these new products, that are more than minimally manipulated, the regulatory pathway will be by/through a BLA submission and that the manufacturing will require the inclusion of a “drug-related” Quality Management System incorporating Risk Management Principles as the underlying mechanism.
This is much more complex and requires a higher level of quality/regulate three compliance that has previously been the case, so going forward, that is going to be much more infrastructure required in order to have the products licensable. For some organizations, this may cause a potential gap in knowledge. As a result, in the near future this will require significant resources that in some cases can be fulfilled using medical management consultants. Doubtless the full impact of this will be felt in the next few years.