Mutual recognition agreement signed between Australia and Singapore on medicinal products good manufacturing practice inspection

A Mutual Recognition Agreement (MRA) on conformity assessment between Australia and Singapore was signed in Canberra on 26 February 2001.

The Agreement includes three industry sectors (Medicinal Products GMP Inspection, Electrical and Electronic Equipment, and Telecommunications Equipment) of which the Therapeutic Goods Administration (TGA) has the responsibility for the Medicinal Products GMP Inspection annex.

In January 2000, Singapore joined the Pharmaceutical Inspection Cooperation Scheme (PIC/s) which was a pre-requisite for finalising an MRA in the medicinal products GMP inspection sector. As a result of this membership, the TGA now recognises Singapore's GMP certificates as acceptable forms of evidence in support of applications for entry on the Australian Register of Therapeutic Goods (ARTG). It should be noted that this does not constitute drug/medicine approval, GMP inspection is only one element of this. One of the benefits of the MRA is that it will formalise the current agency level PIC/s arrangement that the TGA has with Singapore, at a higher governmental level.

The agreement is of treaty status. It is anticipated that the Electrical and Electronic Equipment annex and the Telecommunications annex will come into force on 1 June 2001. The Medicinal Products (GMP) Inspection annex will enter into force once amendments to the Therapeutic Goods Act 1989 have been made.