Indonesian Pharmacopoeia to adopt and adapt USP-NF Standards

With an aim to promote harmonisation of standards for the quality of medicines and their ingredients, The United States Pharmacopeial Convention (USP) and Indonesia’s National Agency for Drug and Food Control (NADFC) have signed a letter of agreement that allows NADFC to translate, copy, adapt and incorporate materials contained in the United States Pharmacopeia and the National Formulary (USP–NF) into the Indonesian Pharmacopoeia.

“The fact that the NADFC values the standards in USP–NF and wants to translate and adapt them for their Indonesian Pharmacopoeia shows the level of commitment to public health that USP seeks in its many international collaborations. Efforts to harmonise standards support people’s confidence in the common quality of medicines across countries and regions, and that aligns with USP’s public health mission,” said Roger L Williams, Chief Executive Officer, USP.

The agreement is valid for five years, during which the NADFC may use information published in the USP–NF and its supplements to modernise the country’s pharmacopoeia. The NADFC is not allowed to use the contents of USP–NF in any publication other than the Indonesian Pharmacopoeia.

USP is a scientific non-profit organisation that sets standards for the quality, identity, purity, and strength of medicines, food ingredients, and dietary supplements. USP’s standards are used in more than 140 countries.

Dr A Retno Tyas Utami said, “NADFC appreciates the assistance from USP. We will adapt the content of USP–NF to suit our local needs in order to promote access to good quality medicines in the Republic of Indonesia. We recognise the USP–NF as a prime reference of science-based standards for pharma products.”

Dr Utami works in the Therapeutic Product and Narcotics, Psychotropic and Additive Substance Control group in NAFDC, which is responsible for publication of the Indonesian Pharmacopoeia.

EP News Bureau

Comments (0)
Add Comment