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...
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...
July 20, 2022
5 Benefits of Receiving EU PRIME Designation for Medicine Developers
What it is, why it matters, how you can apply and how we can help. What is the PRIME Scheme? You might be forgiven if you don’t know what the PRIority MEdicines (PRIME) scheme is; but if you are in...
June 22, 2022
Maximising on Scientific Advice Procedures in Europe
A unique opportunity to interact with medicine regulators in Europe Are you considering requesting scientific advice in Europe? We can help you navigate the various procedures within the European...
June 15, 2022
EMA adopts first list of critical medicines for COVID-19
News On 7 June 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised...
June 2, 2022
EMA: Procedural advice for vaccine platform technology master 5 file (vPTMF) certification (DRAFT)
This document is intended to provide advice to marketing authorisation (MA) applicants and marketing authorisation holders (MAHs) on issues associated with the submission, evaluation, certification...
May 24, 2022
EMA post-authorisation procedural advice for users of the centralised procedure
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on...
February 15, 2022
CMC Regulatory Dossier Compliance: A GMP Requirement
Maintaining compliance in the dynamic regulatory Chemistry, Manufacturing and Controls (CMC field can be quite a challenge. A CMC regulatory dossier compliance assessment is a critical component and...
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...