North America
EMA
August 22, 2022
Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study
Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study Many advanced therapy medicinal products (ATMPs) in development in the EU are for rare diseases and conditions. Since the...
PDP
PMA
August 9, 2022
From Idea to Market: The Five Stages of Product Development
From Idea to Market: The Five Stages of Product Development. The exact product development process for medical devices differs from region to region, with different regulatory expectations that need...
FDA
MHRA
August 8, 2022
Early engagement with Health Technology Assessment authorities will accelerate product launch and improve chances for reimbursement
Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...
EMA
EU
July 28, 2022
Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Introduction - EU Implemen
The Europe Introduction - EU Implementation Guide has been prepared by the European Medicines Agency (EMA) upon consultation with different stakeholders (representatives of marketing authorisation...
EMA
EU
April 26, 2022
Facilitating global access to diabetes treatments for non-EU patients Share
April 22, 2022 EMA’s human medicines committee (CHMP) has given a recommendation for two diabetes mellitus treatments, Actrapid and Insulatard, for use outside the European Union (EU). EMA is...
EMA
EU
December 22, 2021
Regulatory Strategy for Clinical Trials in the European Union
Regulatory Strategy for Clinical Trials in the European Union: Setting up a clinical trial in the European Union (EU) has historically been an expensive and time-consuming business. With 27...
QP
API
November 9, 2021
A Roadmap for Clinical Trials: QP Certification of IMP
Please note that updates to regulations may have been implemented since the publication of this article. The 20th century was the century of many scientific discoveries in the field of medicine....
FDA
EU
October 13, 2021
European Expedited Regulatory Programs Explained
Do you really know how to accelerate the approval of your innovative product in Europe? European Expedited Regulatory Programs: The FDA’s incentives for promising new medicines are widely known....
EU
MAH
September 3, 2021
The Essential Guide to Local Person for Pharmacovigilance
Every marketing authorization holder (MAH) needs a pharmacovigilance system to guarantee the safety of its products. When setting up a pharmacovigilance system in Europe, the Qualified Person for...