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US FDA will send ‘cGMP declarations’ to regulatory authorities in other countries where firms want to market drug products made in the US. There is some hope that the declarations will fill in for EU GMP certificates no longer issued for US manufacturing facilities now that there is a US/EU mutual recognition agreement on inspections.
Latest From Manufacturing
Concerns that the US pharmaceutical industry will not have the necessary serialization systems in place to fully comply with DSCSA product package serialization requirement appear to be bearing fruit, according to a recent survey.
The key to pediatric approval for a flu vaccine: a manufacturing root cause investigation and subsequent process improvements.
A proposed revision of the EU GMP Guide’s Annex 1 calls for microbiologists to get out of the lab and more involved in risk assessments to ensure that sterile products are free from contamination, according to the annex’s rapporteur.
The European Medicines Agency is continuing to work on revising Annex 1 of the EU GMP guideline even as the agency focuses more on core tasks like responding to urgent public health threats amid greater-than-expected staff departures in advance of its Brexit-driven move from London to Amsterdam.
“Vested interests” are pressuring EU policymakers to water down further European Commission plans for an exemption intended to allow generic and biosimilar firms to manufacture their versions of products for export while SPCs are still in effect, claims the industry sector body Medicines for Europe.
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