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Archive for ‘November, 2011’

Growing Cooperation Between FDA and EMA Highlighted in Recent Ben Venue Inspections

The mutual focus of FDA and EMA on aseptic processing compliance at Ben Venue’s Bedford, Ohio plant – which has resulted in an EMA recommendation to recall three oncology drugs contract-manufactured by Ben Venue and the firm's decision to cease operations at the facility while the issues raised are being addressed – illustrates the increasing level of cooperation among international agencies in the GMP arena....
November 29, 2011 | Posted in Authorities, Contractors/Suppliers, Europe, GMP Deviations/Warning Letters, GMP Enforcement Activity, GMP Policy, Inspections/Info Sharing, International Harmonization, Region/International, The News in Depth, US/Canada | Read More »

USP MAb General Chapters on Fast Track

USP has set an aggressive goal of April, 2012 to complete drafts of a mandatory general chapter (<129>) covering critical quality attributes (CQAs) of recombinant therapeutic monoclonal antibodies (MAbs) and an informational general chapter (<1260>) addressing a broader range of monoclonal manufacturing and control issues....
November 27, 2011 | Posted in Biotech Therapeutics, CMC Standards, Compendial, Region/International, Specific Product Type, The News in Depth, US/Canada, Vaccines/Biologicals | Read More »

EMA Invites Registrations for eSubmission Gateway

The European Medicines Agency (EMA) is inviting pharmaceutical companies to register to take part in a three-month pilot of its “eSubmission Gateway” beginning on January 9, 2012. The eSubmission Gateway is a new electronic submission channel that applicants will be able to use to submit applications for centralized marketing authorizations for human medicines in the Electronic [...]
November 24, 2011 | Posted in CMC Review Policy, Europe, Marketing Application/General, News Brief, Region/International | Read More »

EMA Scales Back its Roadmap Vision to Match Resource Reality

EMA is scaling back the number of projects it will be working on outside of its core business as economic realities and flat staffing levels impact its ability to pursue some longer-term objectives....
November 22, 2011 | Posted in Authorities, CMC Review Policy, Europe, GMP Policy, Inspections/Info Sharing, Internal Agency Management, International Harmonization, Region/International, The News in Depth | Read More »

FDA’s ONDQA Bolsters its QbD Review Effectiveness

FDA is continuing to refine its quality-by-design (QbD ) review framework by creating QbD “CMC lead” and “liaison” positions within the Office of New Drug Quality Assessment (ONDQA), instituting an internal database of QbD application elements for use by reviewers, and increasing collaborative research between ONDQA and academia on QbD-focused topics....
November 21, 2011 | Posted in CMC Review Policy, CMC Standards, ICH Q8-10/QbD, International Harmonization, Marketing Application/General, QbD, Region/International, The News in Depth, US/Canada | Read More »

Hydrochloric Acid Shortage Prompts Testing of Incoming Shipments

A recent shortage of technical grade hydrochloric acid (HCl) is beginning to impact the supply of high purity HCl used in pharma manufacturing, according to the supply chain consortium Rx-360.  It has confirmed the shortage condition and notes that there have been recent reports of specification failures of HCl tested at incoming inspection at some [...]
November 17, 2011 | Posted in Component Supply, News Brief, Region/International, Supply Chain/GDPs, US/Canada | Read More »

European Commission Clarifies Position on Duplicate MAAs

The European Commission has published its position on the “handling of duplicate marketing authorization applications (MAAs),” explaining the circumstances in which duplicate MAAs can be submitted for the same product.  The document notes that duplicates are on the increase “as the use of the centralized procedure rises.” In general, only one MAA can be granted to [...]
November 16, 2011 | Posted in CMC Review Policy, Europe, Marketing Application/General, News Brief, Region/International | Read More »

EDQM Publishes First Monthly Report on Certification of Substances

The European Directorate for the Quality of Medicines (EDQM) has published its first monthly report on the Certification of Substances Division (DCEP) The September report notes that the DCEP received 32 new certification (CEP) requests in September and approved 20.  It also received 122 revisions, including notifications and renewals, and suspended or withdrew five CEPs. Another [...]
November 15, 2011 | Posted in API, Asia, Europe, GMP Enforcement Activity, General, Inspection Initiatives, International, News Brief, Region/International | Read More »

Current Staffing Levels at China’s SFDA May Hinder QbD Submissions; Investigational-Stage Changes and Timelines Also at Issue

International pharma is expressing concern that the ability to put ICH Q8-10 principles into practice in China is hampered by the significant limitations in its current review manpower....
November 14, 2011 | Posted in Asia, CMC Review Policy, CMC Standards, ICH Q8-10/QbD, International Harmonization, Marketing Application/General, QbD, Region/International, The News in Depth | Read More »

China’s CMC Harmonization Efforts Provide Opportunities for Industry Input

The China State Food and Drug Administration (SFDA) initiative to adopt selected international guidelines offers significant opportunities for industry to work closely with the agency to help it move toward a more science and risk-based approach to its CMC review process in line with the ICH model, industry regulatory experts are stressing....
November 13, 2011 | Posted in Asia, CMC Standards, General/Quality, ICH Q11, ICH Q8-10/QbD, International Harmonization, Pharmacopeias, QbD, Region/International, The News in Depth, WHO | Read More »
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