Partial US Government shutdown is straining the FDA

A partial United States (US) Government shutdown has hindered the Food and Drug Administration’s (FDA’s) ability to accept and review regulatory submissions. A notice from the FDA on Government funding lapses, which started in December 2018, states that currently the FDA has no legal authority to collect user fees assessed for their 2019 fiscal year, which prevents the FDA from accepting new regulatory submissions such as 510(k)s and Premarket Applications (PMA) that require fees until Congress and the White House restore full funding. If you are planning to submit applications for US market authorisation in early 2019, you should factor these operational delays at FDA into your commercialisation plans. Read more “Partial US Government shutdown is straining the FDA”

MHRA releases final consultation response for the Falsified Medicines Directive

A public consultation was launched by the Government in July 2018 regarding actions that need to be taken to ensure that the United Kingdom (UK) meets its obligations to apply the provisions of the Falsified Medicines Directive (FMD). The FMD requires ‘safety features’ to be applied to the packaging of specified medicinal products. The consultation closed on 23rd September 2018, and the final consultation response has been published with the Medicines and Healthcare Products Regulatory Agency’s response to over 50 replies that were received from a variety of stakeholders. Read more “MHRA releases final consultation response for the Falsified Medicines Directive”

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”

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”