Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 192

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 192
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 satisfactorily completing
each of the following:

| • | preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the applicable European Union 
 good laboratory practice regulations;                                                                                               |

| • | submission to the relevant national authorities of a clinical trial application, or CTA, which must be approved before human clinical 
 trials may begin;                                                                                                                     |

| • | performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed 
 indication;                                                                                                                       |

| • | submission to the relevant competent authorities of a marketing authorization application, or MAA, which includes the data supporting      
 safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed 
 labeling;                                                                                                                                  |

| • | satisfactory completion of an inspection by the relevant national authorities of the manufacturing facility or facilities, including 
 those of third parties, at which the 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