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Country's Decision or any other Communication
Record information and status
Record ID
111984
Status
Published
Date of creation
2017-06-03 20:49 UTC (tim.strabala@epa.govt.nz)
Date of last update
2018-02-23 09:52 UTC (tim.strabala@epa.govt.nz)
Date of publication
2018-02-23 09:52 UTC (tim.strabala@epa.govt.nz)

General information
Country submitting the decision or communication
  • New Zealand
Competent National Authority(ies) responsible for the decision or communication
Environmental Protection Authority
215 Lambton Quay
Private Bag 63002
Wellington
New Zealand
Phone:+64 (0)4 474 5591
Fax:+64 (0)4 914 0433
Email:neworganisms@epa.govt.nz
Url:New Organisms, Environmental Protection Authority
Title / Reference number of the decision or communication
Decision - APP202601
Date of the decision
2015-10-27
Is the decision taken prior to entry into force of the Protocol?
No
Jurisdiction
  • New Zealand
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
No
Importer’s or Applicant’s contact details
Sillagen
11th Floor, HP bldg
83 Uisadang-daero, Yeongdeungpo-gu
Seoul
Republic of Korea
Phone:+82 (2) 368-2600
Url:SILLAGEN
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
Control 1 - The applicant must ensure that the organism (Pexa-Vec, pexastimogene devacirepvec; JX-594; as described in Table 1) is only administered:
a) to individuals enrolled in a Phase 3 clinical trial approved under the Medicines Act 1981 to examine the safety and efficacy of Pexa-Vec in patients with hepatocellular carcinoma;
b) intratumourally;
c) by a suitably trained medical practitioner(s); and
d) at a Phase 3 clinical trial site
Control 2 - The New Zealand sponsor of the Phase 3 clinical trial must notify the EPA and Ministry for Primary Industries (MPI), in writing, and at least one calendar month before Pexa-Vec is administered for the first time at each clinical trial site, of:
a) the location of the Phase 3 clinical trial site; and
b) the qualifications of the suitably trained medical practitioner(s) who will administer the organism.
Control 3 - The New Zealand sponsor must ensure a suitably qualified person(s), before treatment:
a) educates the individual who will be treated with the organism about the potential for Pexa-Vec to be transmitted to untreated individuals and animals (and potential adverse effects of Pexa-Vec transmission);
b) advises such individuals to report any adverse effects suspected to be related to Pexa-Vec transmission; and
c) instructs such individuals on pustule management practices (particularly to avoid contact with immunocompromised people if pustules form following treatment).
Control 4 - The New Zealand sponsor must ensure that a suitably qualified person(s):
a) before treatment, provides the individual who will be treated with the organism with a biohazard container for disposal of used pustule dressings;
b) before treatment, instructs such individuals to return these containers to a Phase 3 clinical trial site for medical waste disposal; and
c) disposes of such containers in accordance with medical waste disposal procedures in place at that Phase 3 clinical trial site.
Reasons
To manage environmental risk associated with the LMO.
Does the decision involve field trials?
No
Does the decision involve commercial release?
No
LMO identification
Pexa-Vec Vaccine
Production of medical or pharmaceutical compounds (human or animal) - Vaccines Selectable marker genes and reporter genes
Risk assessment
Pexa-Vec hepatocellular carcinoma therapy in clinical trial
Pexa-Vec Vaccine
Production of medical or pharmaceutical compounds (human or animal) - Vaccines
Selectable marker genes and reporter genes
Decision document