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Set Alert for Manufacturing

FDA Offers New ‘cGMP Declarations’ That Could Fill US Gap In EU GMP Certificates

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.

Compliance Manufacturing Quality

Latest From Manufacturing

Survey Shows Drug Makers Don't Expect To Begin Serializing All Packages By November Deadline

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.

United States Manufacturing

Seqirus Completes Long Journey To Restore Afluria's Pediatric Indication

The key to pediatric approval for a flu vaccine: a manufacturing root cause investigation and subsequent process improvements.


Manufacturing Vaccines

EU GMP Annex 1 Would Give Microbiologists A Greater Role In Sterility Assurance, Rapporteur Says

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.

Europe International

Data Integrity And The Iceberg Concern

US FDA official outlines a number of issues around data integrity lapses, including how they trigger concern around all records of a non-compliant firm and that certain factors, including the limited oversight of sponsors over CMOs, could potentially be linked with data integrity problems.
Manufacturing India

EMA Aims To Carry On With EU GMP Annex 1 Revision Despite Brexit-Related Staff Departures

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.

Europe Manufacturing

EU Policymakers Under Industry Pressure To 'Neuter' SPC Waiver Plan

“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.

Biosimilars Generic Drugs
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