Japan to share API plant inspection data with international regulators

By Gareth Macdonald

- Last updated on GMT

iStock/arunchristensen
iStock/arunchristensen

Related tags European union Food and drug administration

European Union and Japanese regulators have announced they will share details of API manufacturing facility inspections.

The Japanese Pharmaceutical and Medical Devices Agency (PDMA) agreed to exchange plant inspection data last week according to the European Medicines Agency (EMA), which said decision extends the reach of an already established international collaboration.

The PDMA joins national regulators in five EU member states, the EDQM, the US FDA, the Australian TGA, Health Canada and the WHO, which have been sharing details of active pharmaceutical ingredient (API) facility inspections under a collaboration established in 2011.

The currently London-based​ EMA said PDMA membership will help “to increase cooperation and mutual reliance between regulators participating in the initiative, as well as to ensure the best use of inspection resources worldwide​.”

An EMA spokeswoman told us "PMDA’s involvement will increase cooperation and mutual reliance between regulators participating in the initiative as well as ensure the best use of inspection resources worldwide.

"It will allow more sites to be monitored and reduce unnecessary duplication.​"

She added that: "The types of information shared include inspection plans and inspection outcomes for inspections carried or proposed to be carried out.

"Information sharing will be facilitated to the extent that confidential information is not compromised by the presence of appropriate confidentiality agreements between the exchanging parties and no local legislative impediments to the exchange​."

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