Company: NCNA
Filing Date: 2025-03-20
Form Type: 20-F
Source: 0000950170-25-042709
Chunk: 172

Company: NuCana plc
Filing Date: 2025-03-20
Form: 20-F
Item: Item 4
Chunk 172
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 EMA Committee is then forwarded to the Commission, for the start of the decision making process. As in the centralized procedure, this process entails consulting various European Commission Directorates General and the Standing Committee on Human Medicinal Products or Veterinary Medicinal Products, as appropriate.
 In April 2023, the European Commission issued a proposal for a new Directive and a new Regulation, which will revise and replace the existing general pharmaceutical legislation. If adopted and implemented as currently proposed, these revisions will significantly change several aspects of drug development and approval in the European Union.
 The United Kingdom formally left the European Union on January 31, 2020. At that time, U.K. medicines legislation was updated to reflect various procedural changes. To date, U.K. medicines legislation has not materially deviated from the law that applied prior to the United Kingdom’s departure from the European Union. The U.K. government has not suggested making material amendments to the requirement to obtain or maintain a marketing authorization for a new medicine.
 Since the United Kingdom’s withdrawal from the European Union, the U.K. regulator, the MHRA, has issued guidance on how to apply for Marketing Authorization. This procedure remains largely the same as it was before the United Kingdom formally left the European Union. However, the MHRA has outlined the International Recognition Procedure, whereby the United Kingdom may rely on a decision taken by certain “Reference Regulators” in order to grant a U.K. marketing authorization on an expediated manner. In most cases, if the marketing authorization was granted by a Reference Regulator within 2 years before the application is submitted in the United Kingdom, the review period will be 60 days. In other instances, the review period will be 110 days. The Reference Regulators include the FDA, the EMA and the competent authorities in each member state of the European Union, Switzerland, Australia, Canada, Japan, and Singapore.
 For other countries outside of the European Union, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, again, the clinical trials are conducted in accordance with GCP and the other applicable regulatory requirements.
 If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension of clinical trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
 Coverage, Pricing and Reimbursement
 Significant uncertainty exists as to the coverage and reimbursement