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FDA’s Center for Veterinary Medicine Using QbR and Other CDER-Tested Approaches to Decrease Review Times; CVM User Fees Drive Guidance Development

The use by FDA’s Center for Veterinary Medicine (CVM) of a question-based review (QbR) approach in CMC submissions over the past three years has resulted in significantly decreased review times for both new and abbreviated new animal drug applications (NADAs and ANADAs) for multiple dosage forms, including sterile products – in many cases with the reviews accomplished in a single cycle....

ICH’s Lifecycle Management Initiative Q12 is Targeting the Tough Regulatory Issues, With Patient Supply a Driving Concern; Analytical QbD Also on Expanded ICH Agenda

The ICH Q12 effort to create a more improvement-friendly and harmonized regulatory approach to pharmaceutical product lifecycle management is being driven by concern about the availability and reliability of supply as well as product quality and will address the “tough” regulatory issues involved, GSK CMC Regulatory Strategy VP Moheb Nasr stressed in an update on the ICH initiative in December. Nasr has been appointed to serve as Q12 rapporteur....

EMA Update on Adaptive Pathways Pilot Project

In an article published in Clinical Pharmacology and Therapeutics in December, EMA and its scientific committee members advocated using adaptive licensing pathways where appropriate in lieu of those used for traditional marketing authorizations. The article notes patients demand for timely access to medicines for unmet needs, a better understanding of pathologies for subgroups of patients, […]

UK Innovative Medicines and MedTech Review

A review is being launched by the UK government to look at speeding up patient access to cost-effective and innovative medicines. The announcement notes that “a fresh approach, made possible by ground-breaking developments in genomics and digital technology, could significantly reduce the time it takes to develop new medicines, devices and diagnostics.”

EFPIA and EGA Release Joint Statement on Europe 2020 Strategy

In mid-December, the European Federation of Pharmaceutical and Industry Associations (EFPIA) and the European Generics Association (EGA) released a joint statement to the European Commission (EC) covering what they believe the EU pharma sector would need to compete globally. The organizations see adopting efficient regulations, promoting a stable pharma market, making Europe attractive for investment […]

EMA Work Program 2015-2016

In mid-December, the EMA Management Board adopted a work program and budget for 2015, as well as a draft program and budget for 2016. The priorities decided upon include facilitating/enhancing: ● quality, regulatory and scientific consistency in assessments ● early stage development of human and vet medicines ● international cooperation within Europe and internationally ● […]

Overview of Comments on EMA Biosimilar Draft Guideline

In December, EMA released an overview of the comments it received on its draft guidance on biosimilars. Comments of note include an accepted comment by the Austrailian Therapeutic Goods Administration (TGA) asking that the phrase “biosimilar” be used to describe “similar biological medicinal Products” and a partly accepted comment by Amgen asking that “posology” be […]

Draft FDA Guidance on Obtaining a REMS Equivalence Letter

In early December, FDA released a draft guidance on how to request a letter stating that a potential applicant’s bioequivalence (BE) study protocol contains safety protections comparable to those in the risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) applicable to the reference listed drug (RLD). Obtaining a REMS equivalence […]

IPQ Monthly Update, November 2014

In focus are the structure, function and impact of two components of the new Office of Pharmaceutical Quality that will be on the front line of its industry/agency interactions: ● the Office of Program and Regulatory Operations (OPRO), which will play a pivotal role in CMC reviews, and ● the Office of Surveillance, which will be spearheading the agency’s effort to more coherently assess a company’s quality management. Included on the international front are stories on: ● how the Europe-based association APIC is mapping API requirements in emerging countries and working with them to make their processes more effective and user friendly, and ● IPEC’s efforts to narrow the excipient maker/user communication gap on visible particles....

APIC is Mapping API Requirements in Emerging Countries and Working with Them to Create More Transparent, Efficient, and Harmonized Regulatory Processes

The Europe-based Active Pharmaceutical Ingredients Council (APIC) is mapping out the current API registration requirements in emerging countries, defining best practices, and developing strategies for working with the various authorities on creating more transparent, efficient and harmonized regulatory processes....
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