Marketing Authorisation Application
How will the revised pharmaceutical regulation change the Marketing Authorisation Application?
In this blog, we explore the current EU marketing authorisation framework, examine the proposed legislative changes affecting the MAA process, and discuss what these updates could mean for pharmaceutical and biotechnology companies […]
Novel medicines approved in 2024: A review
The European Medicines Agency (EMA), the Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) approved 53 novel medicines in 2024; with 53% of these products being […]
What is the MHRA’s Innovative Licensing and Access Pathway (ILAP)?
The ILAP pathway is available to global commercial and non-commercial medicine developers. ILAP supports organisations developing new chemical substances and biologics, and new indications.
MHRA ILAP Relaunch 2025: Innovation Passport, Eligibility & Accelerated Access
The Innovative Licensing and Access Pathway (ILAP) is evolving to bring transformative medicines to NHS patients faster. Relaunching in March 2025, the updated pathway will feature streamlined processes, selective entry criteria, and […]
Module 1 of the CTD: Key Components of a Marketing Authorisation Application
Module 1 of the common technical document (CTD) is not part of the CTD and contains region-specific information.
European Medicines Agency vs Food and Drug Administration for approving new medicines
There are many similarities and but important differences between how the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) evaluate new drugs.
What are regulatory data and market exclusivity? Drug approval in Europe
Exclusivity, both market and data, refers to the length of time an approved medicinal product will be protected from similar competitors.
The 2023 oncology medicine approvals from the European Medicines Agency (EMA)
This executive summary focuses specifically on the oncology medicine approvals and in particular, those that were approved under a CMA.
How does the EMA evaluate a Marketing Authorisation Application (MAA)?
Learn how the European Medicines Agency evaluates your Marketing Authorisation Application (MAA) after your have submitted your MAA dossier.
How to get a drug approved by the European Medicines Agency
Submitting your MAA to the EMA is a significant undertaking, involving a team of 20–30 people preparing the Common Technical Document (CTD) dossier over 18–24 months.