F+L Week 2017 | Shana McCabe | Regulatory Hurdles to Entering a New Market as a Small- Medium Sized Company
All companies entering a new market must do their homework. How much risk is involved? How much potential is there? What are the hurdles in manufacturing, logistics, etc. in servicing this market? And the big question…what regulatory hurdles must we face and overcome? While all companies ask themselves this regulatory question, the size of your company can definitely have an impact on your approach and decision. The truth is smaller companies face more obstacles than larger companies. Some of the upfront hurdles that must be anticipated include the following:
- The costs to register in a given region. Different regions require different sets of data and testing protocol, not to mention different fees in each.
- The variability in the minimum required dataset for various regions. End points and tests required are usually more vast than initially thought.
- The variability in options to fill the required endpoint datasets (i.e. QSAR, Read Across, testing and licensing). There are regional specifics regarding testing on animals and environmental differences from region to region that must be taken into account.
- The timing factor to notify the inventory for a given region. In some situations, the best-case scenario could be 24 months of wait time.
- The existing data gap for several substances in your company’s portfolio. Under the new TSCA, a company must provide proven safety documentation as opposed to the old TSCA rules of only needing to show that nothing has shown the substance isn’t safe.
- Tight availability of contract research lab slots. Due to the enormous amount of contract research lab consolidation, the availability to have the necessary testing for regulatory bodies is extremely diminished and the wait time can be long for small companies trying to break in.
These points vary considerably between small and large companies in resource allocation and time. The manner in which the regulatory bodies impact the future approaches to new markets is also significant. EU REACH has completely transformed the regulatory landscape and many additional countries have followed suit coming out with their own version of REACH. One of the largest hurdles that smaller companies face in commercializing new substances is not being able to phase their products into the market over time. Since a new substance isn’t pre-registered, the phase-in of the product on a volume-tiered and time- staggered basis, as previous products were allowed, is not available. A first step for a new substance is an Inquiry Dossier to ECHA. New substances must create an entire dossier prior to being allowed any access to selling in REACH-regulated regions. A new substance will likely have no other data providers to a SIEF, thus costing the first new substance registrant the requirement to bear all of the regulatory costs and burden. Endpoints, even for launch commercialization volumes, may be too expensive for modest value-added specialty chemicals, and may progress exponentially though the required data sets. The burdens mentioned above selectively favor large enterprises with a solid, global footprint. These companies have the resources and competencies to successfully develop registration dossiers with lower costs due to probable large existing datasets for cognate chemistries and can make read-across justifications or waivers. This talk will attempt to address these hurdles in more detail and provide insights into how small- and medium- sized companies can work around these hurdles to successfully enter new markets.