Regulatory Oversight

The author discusses upcoming serialization and transaction data collection regulations including the US Drug Supply Chain Security Act, the European Union Falsified Medicines Directive, and the EU Delegated Regulation.

Serialization and complementary authentication technologies are needed in order to meet DSCSA and FMD regulations.

The agency published an action plan to nurture innovation and drug development by SMEs.

The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.

Approval of breakthrough therapies requires expedited quality assessment.

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.

Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

The company was cited for cGMP violations at its Irvine, California facility.

The agency met with the representatives of the East African Community to discuss the creation of a networking agency.

FDA cited the facility for violations of quality management and data integrity CGMPs.

The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.

A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.

Archana M. Akalkotkar, PhD, research scientist I at Charles River, discusses the use of process validation to ensure quality.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.

The agency released its report on pilot project to involve patients in the assessment of medicines.

User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.

Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.

The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

New study will reveal bio/pharma practices and performance on quality issues.

The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.

Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.

In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.

On April 28, 2017, the European Medicines Agency announced that it met with members of the heads of the National Competent Authorities (NCAs) of the member states of the European Union to discuss the United Kingdom’s exit from the EU (Brexit) and how the agency and the member states will handle the evaluation and monitoring of drugs going forward.

April 24–30, 2017 is European Immunization Week in Europe, and in a statement on the European Medicines Agency (EMA) website dated April 25, 2017, Executive Director Guido Rasi stressed the importance of vaccinations in preventing and controlling disease. Rasi acknowledged that fear created from incorrect information presented by unreliable sources has created a lack of trust in vaccines. But he highlighted that Europe monitors and records information on the safety of medicines, including vaccines.