Singapore legislation
Regulation 26
Regulation 26
Protection of confidential supporting information relating to innovative therapeutic product applications
Subregulation 1
Without prejudice to section 66 of the Act, where the Authority receives an innovative therapeutic product application with confidential supporting information, the Authority, during the protected period in relation to such confidential supporting information —
must take reasonable steps to ensure that the confidential supporting information is kept confidential to the Authority; and
must not use that confidential supporting information for the purpose of determining whether to grant any other application to register a therapeutic product.
Subregulation 2
In this regulation and regulation 27, unless the context otherwise requires —
Definition
“confidential information” includes —
trade secrets; and
information that has commercial value that would be, or would be likely to be, diminished by disclosure;
Definition
“confidential supporting information” means confidential information given —
in, or in relation to, an innovative therapeutic product application; and
about the therapeutic product that is the subject of that application;
Definition
“innovative therapeutic product application” means an application to register a therapeutic product that refers to a substance —
that is an ingredient in the manufacture or preparation of the therapeutic product to which the application relates; and
that has not, before that application is received by the Authority, been referred to as an ingredient in the manufacture or preparation of any other therapeutic product in any other application to register that therapeutic product under the Act;
Definition
“protected period”, in relation to confidential supporting information relating to an innovative therapeutic product application received by the Authority, means a period of 5 years after the date that application is received by the Authority.