FDA introduces expectations for biosimilars, soon to be biologics

The Food and Drug Administration (FDA) have released two new draft question and answers (Q&A) documents on biosimilar development, and the deemed to be a license provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), and two final guidance documents covering the same topics, plus one proposed rule which amends the definition of a biological product. Read more “FDA introduces expectations for biosimilars, soon to be biologics”

France to create clinical trial fast track for cell and gene therapies

France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) are to create a fast track for applications to run clinical trials of cell and gene therapies. The proposed regulatory process will reduce the time it takes sponsors to receive authorisation to start clinical trials to 110 days. Read more “France to create clinical trial fast track for cell and gene therapies”

FDA framework to advance use of real-world evidence to support development of drugs and biologics

The Food and Drug Administration (FDA) have released a new framework which discusses how the agency will use real world evidence (RWE) and real-world data (RWD) to assist companies win new indications for approved drugs and biologics, expand labels or satisfy post-approval study requirements. Read more “FDA framework to advance use of real-world evidence to support development of drugs and biologics”

EMA revises guideline on environmental risk assessment of human medicines

The updated European Medicines Agency (EMA) draft guideline on environmental risk assessment (ERA) now contains a decision tree which clarifies when ERA studies are required, and provides greater detail on technical guidance to help increase the consistency of the assessments. Performing an ERA is mandatory for any pharmaceutical company submitting a marketing authorisation application for a medicine. Read more “EMA revises guideline on environmental risk assessment of human medicines”

ABPI revises guidance for Pharmacovigilance in Market Research

The Association of the British Pharmaceutical Industry (ABPI) and the British Healthcare Business Intelligence Association (BHBIA) have produced a revised version of their guidance on collecting adverse events, product complaints and special situation reports during market research programmes (MRPs). The guidance document was first issued in October 2009, and is now version 4, which took effect from the beginning of October 2018. Read more “ABPI revises guidance for Pharmacovigilance in Market Research”

EMA revises guidance on its policy on the publication of clinical data for medicinal products for human use

The European Medicines Agency (EMA) has outlined the major and minor changes that have been made to the guidance on the agency’s policy on the publication of clinical data for medicinal products for human use. Changes include clarification on publication of data relating to withdrawn applications and a more detailed explanation of the process of publication. Read more “EMA revises guidance on its policy on the publication of clinical data for medicinal products for human use”