This is the third of a series of posts in which I’m presenting an expanded version of a presentation I made in May 2022 at the AIChE 5th Commercializing Industrial Biotechnology conference in San Diego, discussing strategies for planning and implementing regulatory submissions for industrial biotechnology projects involving a partnership with another party. In the first entry, I summarized the different types of relationships that might govern industrial biotechnology commercialization efforts, and presented a summary of the types of information typically needed in biotechnology regulatory submissions. In the second post, I discussed the issues and challenges that might be faced in preparing regulatory dossiers for these different types of commercial partnerships. Today’s post will briefly address issues that might arise when the commercial project will take place in a country other than your own, and would thus be subject to jurisdiction of a possibly unfamiliar regulatory agency.
Dealing with Foreign Regulatory Agencies
Any of the above relationships may pose additional challenges when the use of the microorganism will take place in another country. Naturally, such uses will be regulated under laws and rules of the country where the activity will take place, and often it will be the entity onsite who will be responsible for the regulatory filing and for obtaining any needed permits or approvals. Even where that is the case, the company that has developed the microorganism will need to provide considerable information to the onsite partner, or in some cases even prepare the entire regulatory dossier on the partner’s behalf. Many of the issues discussed above will come into play, with the added complication that you’d be dealing with regulations and regulatory agencies with which you are likely not that familiar.
The following are some recommendations for dealing with a situation where your partnered project is regulated in another country.
- First, obtain an early understanding of the regulatory definitions and requirements in the country where the use will take place. Regulatory regimes differ around the world, and organisms regulated in one country may be exempt in another.
- You clearly can’t do this alone, and assistance from your partner is essential. In most cases, the application will need to be submitted in the name of the local facility even if you as the strain developer prepares most or all of the content of the dossier.
- It is likely that submissions must be filed in the national language of the host country, and so there may be considerable information that will need translation. However, I have found in at least one European jurisdiction that the scientific content of the application was able to be submitted in English even though most other information in the application needed to be in the local language. That is unlikely to be the case in countries like Japan or China, and so you may need to rely on your partner or other local resources in getting documents translated.
- It could be worth considering whether a local attorney or regulatory consultant is needed. This would be less likely if your partner is a functioning biotechnology company and is familiar with national biotech laws and regulations. But if your partner is a customer operating in a different industry (e.g. a cement producer from whom you’ll be taking CO2 from their off-gas), they will likely not have much if any familiarity with the applicable regulations, and so you may need additional professional assistance.
I’ve had reasonable success in coordinating regulatory submissions outside the U.S. in those situations where my client had a good relationship and good lines of communication with the overseas partner. However, there’s no doubt that working with a partner outside your home country adds additional challenges to be managed in developing and submitting a regulatory dossier.
The final installment of this report will appear in an additional blog post within the next few days. To obtain a PDF copy of the entire report, in the form of a white paper, please contact David Glass at firstname.lastname@example.org. D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty-five years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. In addition to his work as a consultant assisting industrial biotechnology companies prepare for and comply with government regulations, he has served as Director of Regulatory Affairs for Joule Unlimited Technologies and Vice President of Government and Regulatory Affairs for BioTechnica International. Dr. Glass has extensive experience with the biotechnology regulations of the U.S. EPA and other agencies, and has coordinated or assisted in the preparation and submission of 18 successful Microbial Commercial Activity Notices and several other biotechnology submissions in the U.S. and other countries. Dr. Glass holds a B.S. in Biological Sciences from Cornell University and a Ph.D. in Biochemical Sciences from Princeton University.