Regulatory Articles

Applied Clinical Trials: Sep 30, 2014
Reshuffling to heavily impact life sciences policy in Europe.
Applied Clinical Trials: Jul 31, 2014
There are 7,000 rare diseases affecting approximately 350 million people around the world.
Applied Clinical Trials: Jul 14, 2014
With the passage of the Biosimilar Price Competition and Innovation Act in 2009, the U.S. created new pathways for development and approval of biosimilar and interchangeable products.
Applied Clinical Trials: Jun 23, 2014
Pharmacovigilance is the next frontier for outsourcing in the pharmaceutical and biologics industry.
Applied Clinical Trials: May 31, 2014
Claims of success for pharmacovigilance are under question, but hopes are higher for new clinical trials rules.
Applied Clinical Trials: May 19, 2014
One of the many activities across the clinical development cycle that is non-negotiable is the creation, collection, management, and storage of the documents that are contained in the Trial Master File.
Applied Clinical Trials: Mar 31, 2014
The advent of new drugs for tuberculosis is posing some interesting challenges for regulators in Europe.
Applied Clinical Trials: Dec 01, 2013
Global action and collaboration is needed to tackle the threat of antibiotic-resistant diseases.
Applied Clinical Trials: Oct 31, 2013
Compromise is going to play a key role as the clinical trial rules update debate rages on.
Applied Clinical Trials: Oct 31, 2013
By Applied Clinical Trials
Pharmacometrics optimizes the use of Phase II data to support Phase III success.

Regulatory News

agDisclosure Supports EudraCT V10

ArisGlobal, a leading provider of solutions to the life sciences industry, has announced that agDisclosure, its clinical trial disclosure solution, now supports Version 10 of the European Medicines Agencys EudraCT database

PwC Report: Regulatory Innovation Should Adapt to New Health Economy

Consumers and drug and device manufacturers are changing practices and shifting attitudes toward the Food and Drug Administration (FDA). Increased pressures for speedy access to breakthrough drugs and medical devices, and a focus on value in addition to medical benefit, are driving these changes.

EU Trial Review Changes from Reg 536/2014: The Netherlands

Over the past few years, the number of active, accredited Ethics Committees (EC) in the Netherlands has dropped at a steady pace. The decline over the past year has partly been due to the merger of several ECs.

EMA Recommends Record Number of Medicines for Rare Diseases

In 2014, the European Medicines Agency (EMA) recommended the highest number of orphan designated medicines for marketing authorization in a year.

EFPIA Boss Renews Support for Health Technology Assessment

The Director General of EFPIA has spoken out strongly in favor of the homogenization of European health technology assessment bodies and regulation.