US pharmaceutical industry groups endorsed the major principles of the International Council for Harmonization’s (ICH) Q5A(R2) guideline on viral safety of biotechnology products but said it could be improved by incorporating continuous manufacturing principles and clarifying materials testing recommendations.   These comments were made in response to FDA’s release of the Q5A(R2) guideline for public comment in November 2022. The deadline for comments was 13 January....

The US Food and Drug Administration (FDA) has issued a new paper  to help shed light on how therapeutic proteins can be produced safely on a continuous manufacturing line.   Continuous manufacturing “is still a novel concept for therapeutic proteins” and more “tangible” examples are needed to implement the program, acknowledged FDA in the report. Further, there are “few published studies” addressing viral inactivation methods for these products.   However, it’s im...

The European Medicines Agency (EMA) has adopted a new guideline on the regulatory requirements for ensuring the viral safety of urine-derived medicinal products. Background Human urine is an essential component in certain hormone-based treatments and some products used to break up blood clots. Products derived from human urine have been available in Europe since the 1970s. While numerous improvements have been made to ensure the safety and purity of these products, spe...

While the US Food and Drug Administration (FDA) may be primarily concerned with what medicinal products do to the human body, a lesser-known secondary concern of regulators is what a product will do to the environment. Background Under 21 CFR 25.40 of the  Code of Federal Regulations , most pharmaceutical and biotechnology companies are required to submit an Environmental Assessment (EA) when submitting a new drug for approval. The assessments are meant to show how a...

The US Food and Drug Administration (FDA) has disbanded its Antiviral Drugs Advisory Committee, a committee charged with the review of products intended to treat HIV and AIDS, and transferred its authority to an existing advisory committee with a new name, the agency announced this week. In a 19 March 2015 posting in the Federal Register , the government's daily record of agency actions, FDA said it was immediately disbanding the committee as it "is no longer needed." ...

Regulatory agencies are often seen by industry as gatekeepers, preventing products from reaching market until after they pass rigorous trials. But in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) is trying to position itself as something else, in part: a facilitator. An example is a new case study issued by MHRA in which the agency describes how it was able to help bring a novel vaccine delivery mechanism developed by the University of Oxfo...