Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 194

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 194
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 product is produced to assess compliance with strictly enforced current cGMP;                   |

| • | potential audits of the non-clinical and clinical trial sites that generated the data in support of the MAA; and |

| • | review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product. |

Preclinical Studies

Preclinical tests include
laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animal studies, in
order to assess the potential safety and efficacy of the product. The conduct of the preclinical tests and formulation of the compounds
for testing must comply with the relevant European Union regulations and requirements. The results of the preclinical tests, together
with relevant manufacturing information and analytical data, are submitted as part of the CTA.

Clinical Trial Approval

The new Clinical Trials Regulation,
(EU) No 536/2014, which took effect on January 31, 2022, aims to simplify and streamline the approval of clinical trials in the European
Union. The main characteristics of the regulation include: a streamlined application procedure via a single entry point, the Clinical
Trials Information System, or CTIS; a single set of documents to be prepared and submitted for the application as well as simplified reporting
procedures for clinical trial sponsors; and a harmonized procedure for the assessment of applications for clinical trials, which is divided
in two parts. Part I is assessed by the appointed reporting Member State, whose assessment report is submitted for review by the sponsor
and all other competent authorities of all European Union Member States in which an application for authorization of a clinical trial
has been submitted (Concerned Member States). Part II is assessed separately by each Concerned Member State. Strict deadlines have been
established for the assessment of clinical trial applications. The role of the relevant ethics committees in the assessment procedure
will continue to be governed by the national law of the Concerned Member State. However, overall related timelines will be defined by
the Clinical Trials Regulation.

As in the United States, similar
requirements for posting clinical trial information are present in the European Union (EudraCT) website: https://eudract.ema.europa.eu/
and other countries.

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PRIME Designation in the European Union

In March 2016, the EMA launched
an initiative to facilitate development of product candidates in indications, often rare, for which few or no therapies currently exist.
The