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The notified text establishes the regulations governing the process to verify compliance with good manufacturing practices for medicines, with the aim of ensuring the quality of medicines, as one of the factors for the reduction of risks associated with manufacturing. It applies to manufacturing plants belonging to national or foreign laboratories that manufacture or market pharmaceutical products in the national territory, to ensure the quality of medicines.
Link to Draft Text
Concern among members of Congress over the Trump administration’s implementation of the updated federal chemicals law burst across the aisle this week, with both the top Republican and Democrat on a key House environment subcommittee calling for oversight hearings.Rep. Paul Tonko, D-N.Y., chairman of the House Energy and Commerce Committee&rs...
As of 1 January 2019, far reaching new rules apply to the disposal of packaging in Germany. Considerably more packaging must be recycled. New standards define to what extent different types of packaging are actually suitable for recycling. In addition, provisions ensure that all businesses using packaging also pay for their collection and recycling...
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological HealthIn 2018, the FDA’s Center for Devices and Radiological Health achieved several new milestones, including a record-setting year for approvals of novel medical devices. We also focused on advancing several meanin...
ECHA Registry of restriction intentionsScope of the restriction: Restricting the use of intentionally added microplastic particles to consumer or professional use products of any kind.Reason: The Commission has requested ECHA to prepare an Annex XV restriction dossier concerning the use of intentionally added microplastic particles to con...
WASHINGTON — U.S. Reps. Debbie Dingell (D-MI), Dan Kildee (D-MI), and Fred Upton (R-MI) have introduced a House bill to combat toxic pollution from per- and polyfluoroalkyl substances (PFAS). The PFAS Action Act would require the EPA to classify all PFAS chemicals as “hazardous substances” under the Superfund program within a year...
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