Company: IPHYF
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001598599-25-000042
Chunk: 138

Company: Innate Pharma SA
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 138
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 include laboratory evaluation of the purity and stability of the manufactured substance or active pharmaceutical ingredient and the formulated product, as well as in vitro and animal studies to assess the safety and activity of the product candidate for initial testing in humans and to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to national regulations and requirements, including Good Laboratory Practices (GLP) regulations. The results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical studies, among other things, are submitted to the applicable regulatory agency in connection with the application to begin human testing. Some long-term preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity, and long-term toxicity studies, may continue after submission of the application.

Regulation of clinical trials

In humans, clinical trials are usually carried out in three Phases that are generally sequential, but under certain circumstances Phases of trials can overlap or even be skipped, following a specific review and determination by regulatory agencies. Clinical trials are sometimes necessary or required by regulatory authorities after marketing authorization to explain certain side-effects, investigate a specific pharmacological effect or obtain more accurate or additional data. Additional trials are also commonly conducted to explore new indications. Regulatory authorization and ethics approvals are needed to carry out clinical trials. The regulatory authorities may put on clinical hold, block, suspend or require significant modifications to the clinical study protocols submitted by companies seeking to test products, including the imposition of clinical holds before or after a clinical trial has commenced.

Clinical trial authorization in the European Union

In the European Union, clinical trials are governed by the Clinical Trials Regulation (EU) No 536/2014 (CTR), which entered into application on January 31, 2022, repealing and replacing the former Clinical Trials Directive 2001/20 (CTD) and related national implementing legislation of EU Member States.

The CTR applies to interventional clinical trials on medicinal products and to clinical trials authorized under the CTD with a three-year transition period from the CTR that has come into operation. As from January 31, 2023, all new clinical trial applications are registered pursuant to the CTR. Trials approved under the CTD before January 30, 2023 can continue to be regulated under the CTD until January 30, 2025.

The CTR allows better consistency throughout EU Member States:

• Single submission of the clinical trial application dossier through the EU Clinical Trials Information System (Article 5) including a common