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Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

Agency IQ

According to a follow-up document (direct download) concerning a resolution on the EU’s authorization procedure for pesticides, the Commission noted that 21 safeners were “known to be used in plant protection products.” Until now, these substances have been effectively subject to authorization at the member-state level.

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Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

In April 2023, the first update ( link is a direct download) from the ODTF indicated that it was working to develop a definition for orphan device. Other work packages for the ODTF include information about clinical evidence for this device type, conditional certification, and the use of registries to support conformity assessment.

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