{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-25",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-25.json",
  "legislation": "uksi/2004/1031",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004",
  "path": "regulation/25",
  "kind": "regulation",
  "number": "25",
  "heading": "Transparency requirements",
  "text": "(1) Subject to paragraphs (5), (7) and (10), the sponsor must register a clinical trial in a public registry by the earlier of the following—\n(a) the date on which the first individual is recruited to be a participant in that trial;\n(b) 90 days after the date of approval of the clinical trial.\n(2) Subject to paragraphs (5), (7) and (10), within the period of 12 months beginning with the day after the conclusion of the clinical trial in accordance with regulation 27, the sponsor must—\n(a) publish a summary of the results of the clinical trial in the same public registry or registries (if more than one) as the trial was registered in accordance with paragraph (1); and\n(b) offer to all relevant persons a summary of the results written in a manner that is understandable to laypersons.\n(3) The sponsor may apply for a deferral or waiver of the requirement to register a clinical trial in accordance with paragraph (1), stating why the deferral or waiver is needed—\n(a) at the time of the request for approval under regulation 16; or\n(b) at any time before the date specified in paragraph (1).\n(4) The sponsor may apply for a deferral or waiver of either or both of the requirements in paragraph (2), stating why the deferral or waiver is needed—\n(a) at the time of the request for approval under regulation 16; or\n(b) at any time before the date specified in paragraph (2).\n(5) Where the sponsor applies for a deferral or a waiver in accordance with paragraphs (3) or (4), the Authority may—\n(a) where they consider appropriate, defer the requirement for up to a period of 30 months beginning with the day after the conclusion of the trial, for example, in order to protect commercially confidential information; or\n(b) in exceptional circumstances, waive the requirement, for example, for reasons of national defence and security.\n(6) The sponsor may apply for a further deferral, stating why the deferral is needed, at any time before the expiry of the previous deferral.\n(7) Where the sponsor applies for a further deferral in accordance with paragraph (6), the Authority may, where they consider appropriate, defer the requirement for up to a period of 30 months beginning with the day after the end of the previous deferral period, for example, in order to protect commercially confidential information.\n(8) The Authority must give written notice of their decision to the sponsor—\n(a) at the time the ethics committee provides a favourable opinion in accordance with regulation 18 or 18B, where the sponsor makes the application to defer or waive under paragraph (3)(a) or (4)(a); or\n(b) subject to paragraph (9), within the period of 10 days beginning with the date of receipt of the application to defer or waive the requirement, where this application is made under paragraphs (3)(b), (4)(b) or (6).\n(9) Where the sponsor makes an application under paragraph (3)(b) before the ethics committee provides a favourable opinion in accordance with regulation 18 or 18B, then the Authority may give written notice of their decision on the application for a deferral or waiver to the sponsor at the time the ethics committee provides a favourable opinion.\n(10) Where the clinical trial is a Phase I trial, the Authority may provide an automatic deferral of—\n(a) the requirement to register the trial in accordance with paragraph (1) for up to a period of 30 months beginning with the day after the conclusion of the trial, provided that the sponsor registers the required minimum information in a public registry before the date specified in paragraph (1);\n(b) the requirements in paragraph (2) for up to a period of 30 months beginning with the day after the conclusion of the trial.\n(11) The combined period of deferrals granted under paragraphs (5), (7) and (10) must not be more than the period of 10 years beginning with the day after the conclusion of the trial.\n(12) In this regulation—\n“public registry” means a a primary or partner registry of, or a data provider to, the WHO International Clinical Trials Registry Platform, provided that the registry, or the data provider, facilitates public access to information about the trial in the United Kingdom;\n“relevant person” includes—\n(a)a participant as defined in regulation 2(1);\n(b)where the participant is a minor or an adult unable to give informed consent to take part in the trial by virtue of physical or mental incapacity, the person who has given informed consent in accordance with Schedule 1;\n(c)where the participant would now be unable to consent due to an incapacity the onset of which occurred after the start of the trial, a person who is engaged in caring for the participant or is interested in the participant’s welfare, for example, their legal representative (if there is one) or their next of kin;\n(d)where the participant is unable to receive the summary of results due to death, a person who was engaged in caring for the participant or was interested in the participant’s welfare, for example, their next of kin;\n“required minimum information” includes the particulars identifying the trial and the details of the sponsor and investigator.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 14-26 substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 14"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/regulation/25",
    "retrieved_at": "2026-10-29T05:28:03.775386+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}