Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 193

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 193
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 approved drug may be granted
an extension, and the extension must be applied for prior to expiration of the patent. The United States Patent and Trade Office reviews
and approves the application for any patent term extension or restoration in consultation with the FDA. Similar provisions are available
in Europe and certain other foreign jurisdictions to extend the term of a patent that covers an approved drug, provided that statutory
and regulatory requirements are met.

| 95 |

Regulation Outside the United States

In order to market any product
outside of the United States, a company must also comply with numerous and varying regulatory requirements of other countries and jurisdictions
regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and
distribution of drug products. Whether or not it obtains FDA approval for a product, the company would need to obtain the necessary approvals
by the comparable foreign regulatory authorities before it can commence clinical trials or marketing of the product in those countries
or jurisdictions. The approval process ultimately varies between countries and jurisdictions and can involve additional product testing
and additional administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from
and be longer than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory
approval in another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the
regulatory process in others.

Regulation and Marketing Authorization in the European Union

The process governing approval of medicinal products
in the European Union follows essentially the same lines as in the United States and, likewise, generally involves 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