Global Markets & Trade

We engage policymakers and industry partners globally to encourage the adoption of national laws and regulations to support the development of the biotechnology sector.  Pursuing biotechnology specific outcomes within new trade agreements and modernizing older agreements is important as the biotechnology sector is increasingly global, requiring rules to govern the trade in biotechnology product and foster cross-border collaboration.

Letters, Comments & Testimony
January 31, 2022
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to participate in the 2022 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public Hearing. We hope our contribution will assist the…
January 27, 2022
On Thursday, January 27th, BIO submitted comments in response to the World Health Organization’s (WHO) recently published white paper on the regulation of Cell and Gene Therapy Products (CGTPs). First and foremost, BIO acknowledged that the publication of this white paper is a major milestone in…
December 13, 2021
On Monday, December 13th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Q13 Continuous Manufacturing of Drug Substances and Drug Products. The draft guidance was prepared under the auspices of the International Council for Harmonisation …