thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

MHRA EMA

January 8, 2024

UK/EU Regulatory Developments Review 2023

Introduction The year 2023 has been remarkable in terms of regulatory developments within the UK and EU, characterised by substantial changes, innovative approvals, and strategic initiatives in the...

EU Regulatory Sciences

August 17, 2023

EU Pharmaceutical Legislation Reform

On April 26th, 2023, a Commission formed by the European Health Union proposed a groundbreaking revision of the EU’s Pharmaceutical legislation, marking the most significant reform in over two...

EMA EU

April 13, 2023

EMA’s Regulatory Science Strategy to 2025 is on Track

Key messages from the mid-point achievements report To strengthen regulatory and scientific support for innovative medicines and diagnostics development, in March 2020 EMA published its Regulatory...

QMS EU

April 4, 2023

Expanding EU & UK Market Access with eQMS & Manufacturer's Import Authorisation (MIA) License

This article has been updated since its original publication date. ProPharma holds its own MIA licenses both in the Netherlands to cover batch importation and Qualified Person (QP) batch...

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

The exact product development process for medical devices differs from region to region, with different regulatory expectations that need to be met in the EU, USA, UK and other regions. These precise...

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...

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Inspiring the Future of Drug Development

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