Freedom of Information request on non-clinical study TOX9587(FOI 21-366)
Published 28 June 2021
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6th May 2021 FOI 21/366 Dear
Thank you for your email.
Regarding your request for the non-clinical study TOX9587 (a 1-month Repeated-Dose Oral Toxicity Study of JNJ-212082-AAA in rats with integrated Irwin observations (impurity qualification)) and the specification for Zytiga 500 mg film-coated tablets (abiraterone acetate), this was approved by a centralised procedure through the European Commission (EC) and the European Medicines Agency (EMA - EU/1/11/714/002-003).
We consider that disclosure of this information is likely to damage the MHRA’s relationship with another regulator or country, and thus could damage the UK’s interests abroad. Section 27 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider that there is a general public benefit from releasing documentation related to Zytiga 500mg. However, we consider that the public interest will be better served by not releasing the information as this product is granted by an EC decision, the data submitted would need to be considered by the EMA for release.
We advise that you contact the EMA directly for this information.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.
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Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU