Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 158

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 4
Chunk 158
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 the context of the EU. In addition, drugs are subject to the extensive price and reimbursement regulations of the various EU Member States.
Clinical trials
In April 2014, the EU adopted the Clinical Trials Regulation (EU) No 536/2014), which replaced the previous Clinical Trials Directive. The Clinical Trials Regulation entered into application on January 31, 2022. The Clinical Trials Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS contains the centralized EU portal and database for clinical trials provided for by the Clinical Trials Regulation. 
The goal of the Clinical Trials Regulation is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information. The Regulation requires:

●   consistent rules for conducting clinical trials throughout the EU; and
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●   information on the authorisation, conduct and results of each clinical trial carried out in the EU to be publicly available.
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This aims to increase the efficiency of all trials in the EU with the greatest benefit for those conducted in multiple EU Member States. It aims to foster innovation and research, while helping avoid unnecessary duplication of clinical trials or repetition of unsuccessful trials. The key benefits of the Clinical Trials Regulation include:

●   harmonised electronic submission and assessment process for clinical trials conducted in multiple EU Member States;
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●   improved collaboration, information-sharing and decision-making between and within EU Member States;
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●   increased transparency of information on clinical trials; and
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●   highest standards of safety for all participants in EU clinical trials
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The authorisation and oversight of clinical trials remains the responsibility of EU Member States, with the EMA managing CTIS and supervising content publication on the public website.
Marketing approval
Marketing approvals in the EU may be obtained through a centralized, mutual recognition or decentralized procedure. The centralized procedure results in the grant of a single marketing authorization that is valid throughout the EU Member States, as well as the additional countries of the European Economic Area (Norway, Iceland and Liechtenstein) (EEA).
Pursuant to Regulation (EC) No. 726/2004, the centralized procedure is mandatory for certain products, including those developed by means of specified biotechnological processes, advanced therapy medicinal products (gene therapy, somatic cell therapy, and tissue-engineered products), products for human use containing a new active substance for which the therapeutic indication