The IMWP monographs on Favipiravir and on Favipiravir tablets are an outcome of the pharmacopoeial alert system, which was established in 2019 at the 9th International Meeting of World Pharmacopoeias (IMWP) in Da Nang, Vietnam to ensure pharmacopoeias work together in any relevant public health crisis. An alert under this system was triggered in response to the COVID-19 pandemic to contribute to the global public health response to the pandemic, including by providing support to manufacturers, regulators and stakeholders regarding medicines critical to the COVID-19 response. The main outcomes of the pharmacopoeial alert system meetings can be found in the report of the 12th IMWP.
The main purpose of the IMWP monographs is to ensure that test specifications are available free of charge for those who need them during an emergency situation, such as the current pandemic. The IMWP monographs will allow for quality checks and can be one of the tools used to help prevent the circulation of substandard and falsified products. They are not intended to become official standards (even if they could serve as a basis) or legally binding texts. They will be made publicly available and can be used on a voluntary basis.
The IMWP monographs on Favipiravir and on Favipiravir tablets were developed by the Japanese Pharmacopoeia with support from other pharmacopoeias and are published for public enquiry on the WHO website here: IMWP Monographs on Favipiravir and on Favipiravir tablets. Comments on these monographs are to be sent to the Japanese Pharmacopoeia (IMWPfirstname.lastname@example.org) by 11 June 2021 at latest.
The development of these IMWP monographs on Favipiravir and on Favipiravir tablets does not imply or confer any demonstrated effectiveness in the treatment of COVID-19.