PharmTech.com Innovations in mRNA eBook April 2024 Pharmaceutical Technology
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17
Navigating an Uncertain
Regulatory Environment
for mRNA-based Products
Michele Duggan
is senior manager,
Regulatory Affairs, at
Thermo Fisher Scientific.
Regulations for mRNA products are evolving as the market for mRNA expands.
T
he development of effective vaccines to combat
COVID-19 has showcased the potential of messen-
ger RNA (mRNA) technology, which is now under
exploration for various clinical areas, including
oncology, HIV, rare diseases, and personalized medicine.
Given that the application of mRNA technology is rela-
tively new, regulatory guidelines and industry standards
that address specific aspects of mRNA quality during pro-
cess development are still evolving, with existing resources
primarily focused on mRNA vaccines.
How t h i s g u id a nce w i l l t ra n slate for developers of
mRNA products for other therapeutic modalities remains
to be seen. Developers will need to remain nimble during
this period of evolution and stay aware of emerging reg-
ulator y guidelines applicable for their unique therapies.
Collaborating with a strategic contract development and
manufacturing organization (CDMO) partner that has the
appropriate industry knowledge and experience can help
developers nav igate t hese cha l lenges a nd br ing novel
mRNA products to market faster.
Current and developing regulatory
guidance for mRNA products
m R NA-based products a re cur rent ly reg u lated w it h i n
e x i s t i ng f r a me work s of bot h F DA a nd t he Eu ropea n
Med ici nes Agenc y (EM A). F DA oversees m R NA-ba sed
products under its Center for Biologics Eva luation and
Research (CBER), and the responsible review division is
assigned based on indication (e.g., vaccine, oncology). In
Europe, mRNA-based vaccines can fa ll under dif ferent
reg u l ator y s t at u ses depend i ng on t hei r t a rget (i n fec-
tious disease or not).
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