Regulatory Sciences

How to Successfully Prepare for the HTAR Implementation in the EU

Health technology developers (HTD) planning submission of a centralized Market Authorization Application (MAA) to the European Medicines Agency (EMA) should being preparing today for the...

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Regulatory Sciences

Mandatory HTAR Implementation in the EU: Part 2

How ProPharma Can Help You Ensure Compliance with the New HTAR Requirements The new Health Technology Assessment Regulation (HTAR) will set new requirements for pharmaceutical companies seeking...

Ensure Compliance with EU HTA Regulation (HTAR) Guidelines & Implementation

Regulatory Sciences

Mandatory EU HTAR Implementation: Part 1

Are You Ready for Mandatory EU Health Technology Assessment Regulation (HTAR) Implementation Beginning January 2025? Pharmaceutical companies need to be prepared for the new European Health...

European Union flags outside of EU parliament

Regulatory Sciences

EU Pharmaceutical Legislation Reform: Where Are We Now?

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...

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Clinical Research Solutions

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...

Several European Union flags placed in a row

Clinical Research Solutions

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...

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Clinical Research Solutions

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...

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Quality & Compliance

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...

Clinical Research Solutions

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...

Clinical Research Solutions

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...

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