Introduction

Starting with January 31, 2022, a new European clinical trials regulation with medicinal product is in place, applicable throughout the European Union (EU).

As a matter of fact, this regulation is not very new in a sense that it was already existing since 2014 as guideline for all the EU and European Economic Area (EEA). Just as its title states: Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance.

Hence forward, the previous Directive 2001/20/EC, is repealed, and replaced with the new Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (herein after, “the Regulation”).

To give a small hint, the main difference between the two documents, the Regulation applies only to clinical trials conducted in the EU and it is not applicable to non-interventional studies, per article 1 of the Regulation, therefore the focus will be on interventional clinical trials.

Main objectives

What are the goals and purposes, that determined the EU to ask for a better regulation for clinical trials? Firstly, it is meant to harmonize the process for assessment and supervision of clinical trials, which implies better coordination between member states together with the EU, therefore speed and efficiency.

Second, by giving a European wide applicability, it simplifies sponsors process for requesting authorizations from each member state and ethics committees. To note, in EU the clinical trials are conducted especially with the participation of several member states, each with its national regulation.

How to solve this issue? The Regulation introduces the EU Portal, as per article 80, were all submissions, assessments, conclusions, and authorizations are to be transferred by the member states and by sponsors. Referred legally as EU Portal, in fact the EU introduces something better, in practice, which is the Clinical Trials Information System.

What is its purpose? The Clinical Trials Information System (CTIS) helps and supports information flow between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission, starting with the same date as the Regulation.

Netherland’s overview

To focus on the main subject, Netherlands has introduced a period of transition to comply with the Regulation while the Paragraph 5a of the Dutch Act on Research Involving Human Subjects (WMO) will be repealed. The clinical trials with medicinal products (CTR) will have a transition period of up to 3 years, its application can be observed here.

The transition period is necessary because Netherlands has decided to replace its national law regarding CTRs with the new Regulation, to follow the European legal framework for CTRs and to apply identical rules together with every other Member State.

To facilitate applicants for CTRs within the Netherlands, a special tool has been developed to help interested parties discover if the clinical study falls within the scope of the CTR, which can be consulted here and here.

As described in this section and the previously, it is understood that Netherlands considers itself an integrated party within the framework, mentality, and purpose of scope to fulfill the principles that back-up the Regulation, work together at European level to facilitate the development of a European-wide CTR model and policy that will bring benefits to the EU in its entirety considering the wellbeing and safety of the patients and participants to a CTR.