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Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals.

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Article Periodic Thank You Swiss regulators align with EU on chemicals, biocides

Agency IQ

Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

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Article Periodic Thank You What we expect EU chemical regulators to do in June 2024

Agency IQ

What we expect EU chemical regulators to do in June 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Another consultation is closing this month on a draft implementing regulation that is amending the label format for fluorinated greenhouse gases (F-gases) under the new F-gas Regulation (EU) 2024/573.

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Article EMA Thank You The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation

Agency IQ

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

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Drug labeling authority, UDI program reviewed by Harvard-based researchers

The Pharma Data

The team analyzed UDI-approved drugs between January 2006 and July 2020, during which 21 drugs were approved under the program. The initiative was shuttered due to concerns that the price of some legacy drugs in the US market was rising while not generating new clinical data on those drugs. .

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Article Periodic Thank You EU executive consults on proposed update to PIC chemical lists

Agency IQ

EU executive consults on proposed update to PIC chemical lists Regulation (EU) 649/2012 (PIC Regulation) is the main act on the export and import of hazardous chemicals between the European Union and third countries. Part 1 of the annex lists substances that carry the obligation to submit an export notification.

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Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. It also proposed several packaging changes to safeguard against misidentification. The Medical Gas Safety Act , introduced by Rep.

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