Part 6Amendment to Part 5 (Pharmacovigilance)

Insertion of new regulation A32

regulation 23 + 23.  In Part 5, before regulation 32 (notification of adverse events) insert—

Record keeping

A32.—(1) A sponsor shall keep detailed records of all serious adverse events and serious adverse reactions, including suspected unexpected serious adverse reactions, which occur during the course of a clinical trial—

(a)in the United Kingdom;

(b)conducted outside of the United Kingdom where—

(i)the sponsor of both the trial in the United Kingdom and the trial outside of the United Kingdom is the same or, where the sponsor is a company, in the same group, and

(ii)the investigational medicinal product being tested or used in the trial conducted outside of the United Kingdom is the same as the investigational medicinal product being tested or used in the clinical trial mentioned in sub-paragraph (a).

(2) A sponsor shall evaluate the events and reactions mentioned in paragraph (1), with a view to—

(a)minimising and preventing any risk presented by the use of the investigational medicinal product to which those events and reactions relate; and

(b)taking appropriate measures as soon as reasonably practicable to investigate the risks presented and implement actions for minimising and preventing those risks.

(3) For purposes of paragraph (1)(b)(i), “group” has the same meaning as in Part 15 of the Companies Act 2006 (see section 474(1) of that Act).”.

Amendment to regulation 32

regulation 24 + 24.  In regulation 32 (notification of adverse events), for “subject”, in each place where it occurs, substitute “participant”.

Amendment to regulation 33

regulation 25 + 25.—(1) Regulation 33 (notification of suspected unexpected serious adverse reactions) is amended as follows.

(2) For paragraph (1)(1) substitute—

“(1) A sponsor shall ensure that all relevant information about a suspected unexpected serious adverse reaction which occurs during the course of a clinical trial in the United Kingdom and is fatal or life-threatening is reported as soon as possible to the licensing authority, and in any event no later than 7 days after the sponsor was first aware of the reaction.”.

(3) In paragraph (2)—

regulation 25 3 a + (a)for “paragraph (1)(b)” substitute “paragraph (1)”;

regulation 25 3 b + (b)for “persons or bodies listed in that paragraph” substitute “licensing authority”.

(4) For paragraph (3)(2) substitute—

“(3) A sponsor shall ensure that a suspected unexpected serious adverse reaction which occurs during the course of a clinical trial in the United Kingdom, other than those referred to in paragraph (1), is reported as soon as possible to the licensing authority, and in any event no later than 15 days after the sponsor is first aware of the reaction.”.

(5) Before paragraph (5) insert—

“(4A) Paragraphs (1) to (3) do not apply to suspected unexpected serious adverse reactions specified in the protocol as not requiring immediate reporting.

(4B) The sponsor shall report suspected unexpected serious adverse reactions to which paragraph (4A) applies to the licensing authority in accordance with the reporting requirements, including the time periods for such reporting, that are specified in the protocol.”.

(6) Omit paragraph (5).

Amendment to regulation 35

regulation 26 + 26.—(1) Regulation 35 (annual list of suspected serious adverse reactions and safety report) is amended as follows.

(2) In the heading, omit “list of suspected serious adverse reactions and”.

(3) For paragraph (1) substitute—

“(1) Within the period of 60 days beginning with the day after the day on which the reporting year ends, a sponsor shall, in relation to each investigational medicinal product tested in clinical trials referred to in regulation A32(1), provide the licensing authority with a report on the safety of the participants of those trials.”.

(4) After paragraph (1) insert—

“(1A) A report under paragraph (1) shall include—

(a)the records of, and evaluation relating to, any serious adverse reactions and serious adverse events which have occurred during the reporting year, including suspected unexpected serious adverse reactions, kept or conducted under regulation A32;

(b)the record of the taking of any measures referred to in regulation A32(2)(b);

(c)a description of how any safety concerns in the clinical trial have been assessed and managed; and

(d)a description of the overall safety profile of each investigational medicinal product being tested or used in the trials referred to in regulation A32(1), as well as a summary description of the processes adopted by the sponsor to monitor the overall safety profile of those products.

(1B) The records of serious adverse reactions and serious adverse events referred to in paragraph (1A)(a) may take the form of a list.

(1C) The licensing authority may request that the sponsor provide a list of serious adverse reactions and serious adverse events, including suspected unexpected serious adverse reactions, which have occurred at any time during the reporting year, in relation to a clinical trial referred to in regulation A32(1), where it considers it necessary to do so to investigate specific safety issues—

(a)which emerge from the report under paragraph (1); or

(b)which have otherwise come its attention, and raise concerns about the safety of the trial or the participants.

(1D) The sponsor shall provide the list requested under paragraph (1C) within the period of 30 days beginning with the day of receiving the request, or within such shorter period as the licensing authority may specify in the request.”.

(5) In paragraph (2), at the beginning, for “paragraph (1)” substitute “this regulation”.