Regulation 18 Approval procedure for clinical trialsF1

(1)

Having carried out the assessments required by regulation 17—

(a)

the licensing authority must provide its decision in relation to the request for authorisation to conduct the clinical trial in accordance with this regulation; and

(b)

the ethics committee must give an opinion in relation to the clinical trial in accordance with this regulation.

(2)

The authorities must notify the sponsor of the decision in paragraph (1)(a) and the opinion in paragraph (1)(b).

(3)

A notice under paragraph (2) must—

(a)

be in writing; and

(b)

state that the authorities—

(i)

approve the request for approval,

(ii)

approve the request for approval, subject to conditions specified in the notice, or

(iii)

do not approve the request for approval, setting out the grounds for this decision.

(4)

Subject to paragraphs (7) and (8) and regulation 18C, the authorities must take all reasonable steps to ensure that the notice is given within the period of 30 days beginning with the date on which the authorities notified the sponsor that the request for approval was valid in accordance with regulation 16(8).

(5)

If a notice is given in accordance with paragraph (3)(b)(ii)—

(a)

the notice must specify whether the conditions relate to either or both of the following—

(i)

the licensing authority’s decision on the clinical trial authorisation;

(ii)

the ethics committee opinion;

(b)

the clinical trial is to be treated as approved only if the conditions specified in the notice are satisfied.

(6)

If a notice is given in accordance with paragraph (3)(b)(iii), regulations 18A and 18B apply.

(7)

The time period referred to in paragraph (4) is extended by 90 days where the licensing authority or the ethics committee consults either or both of the following—

(a)

a relevant committee;

(b)

a specialist group or committee.

(8)

If the clinical trial involves a medicinal product for xenogenic cell therapy, the time periods set out in paragraphs (4) and (7) do not apply and the authorities may give written notice under this regulation at any time after the date on which the authorities notified the sponsor that the request for approval was valid in accordance with regulation 16(8).

(9)

Where an ethics committee gives an opinion in accordance with this regulation, it must publish the conclusion of that opinion, whether favourable or unfavourable.

(10)

Where a request for authorisation under regulation 14 and an application for an ethics committee opinion under regulation 15 are made separately in accordance with regulation 16(5)—

(a)

the time periods mentioned in this regulation, regulation 18A and 18B applies separately to the request for authorisation and the application for an ethics committee opinion;

(b)

the clinical trial is to be treated as approved upon receiving both the authorisation from the licensing authority and a favourable opinion from the ethics committee.

Annotations

Textual amendments

F1: 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