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
October 28, 2022
On October 28th, BIO submitted comments to the World Health Organization on its new draft guideline containing regulatory considerations and requirements for the marketing authorization of monoclonal antibodies (mAbs) and related products based on an immunoglobulin framework. In the comments…
October 28, 2022
On October 28th, BIO submitted comments on the ICH E11A Pediatric Extrapolation Guideline as published by the Food & Drug Administration (FDA). In the comments submitted, BIO voiced appreciation for the guideline’s clear explanation for how pediatric extrapolation can be applied practically to…
November 1, 2022
On November 1st, BIO submitted comments in response to the Food & Drug Administration’s (FDA) recent Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. The meeting was primarily focused on two topics: the future of the Quality Management Maturity (QMM) program and the…