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Archive for ‘December, 2011’

PIC/S’ Voluntary, Non-Political Status Touted by Regulators Involved

Regulators involved directly in the Pharmaceutical Inspection Cooperation Scheme (PIC/S) continue to view its voluntary, non-political status as a key component of its effectiveness and do not anticipate a move to change that status....
December 29, 2011 | Posted in Authorities, GMP Policy, International, International Harmonization, PIC/S, Region/International, The News in Depth | Read More »

GDPs, APIs, and non-European GMPs on PIC/S Radar Screen as Membership Expands

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) is taking a close look at the developing global guidance on good distribution practice (GDP), including the new guidance that has been emerging from Europe and WHO, in assessing its expansion into the GDP arena. Also on PIC/S’ radar screen are active pharmaceutical ingredients (APIs) and the organization’s relationship to the GMPs of its expanding membership – in particular, those of FDA....
December 29, 2011 | Posted in Authorities, GDP/Supply Chain, GMP Policy, International, International Harmonization, PIC/S, Region/International, The News in Depth | Read More »

Generic Drug User Fee Act Nearing Finalization

The draft of the Generic Drug User Fee Act (GDUFA) entered its last lap in December before going to Congress for approval with a final public airing of FDA’s “goals letter” at its White Oak, Maryland headquarters that produced little public comment. Written comments on the draft “goals letter” are due by January 6, 2012....
December 29, 2011 | Posted in CMC Review Policy, Generic, Generic/Biosimilar, Region/International, Specific Product Type, The News in Depth, US/Canada | Read More »

FDA Releases Biosimilar Authorization Performance Goals for Comment as Efforts to Implement the New Act Continue

FDA has released for comment a draft of its 2012-2017 performance goals for authorizing biosimilar products as called for under the terms of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Comments are due by January 6, 2012....
December 28, 2011 | Posted in Authorities, Biosimilar, Biotech, CMC Review Policy, CMC Standards, GMP Policy, Generic/Biosimilar, Region/International, Specific Product Type, The News in Depth, US/Canada | Read More »

UK’s MHRA Proposes Fee Reductions

In late December, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released a draft document for comment that proposes to reduce industry fees – excluding those paid by blood establishments and blood banks – and consolidate the fees into a single set of comprehensive regulations.  Comments are due by January 31, 2012. In the draft, [...]
December 21, 2011 | Posted in Authorities, Europe, GMP Policy, News Brief, Region/International | Read More »

IPQ Monthly Update — November 2011

The Monthly Update covering key CMC and GMP developments in the US, Europe and internationally during November is now available.......
December 16, 2011 | Posted in Current Issue, Issue Archive, Monthly Update | Read More »

IPQ’s Monthly Update for November is Now Available

China’s CMC and GMP landscape is changing, providing opportunities for the global pharmaceutical community to help shape the outcome. The Monthly Update for November includes a series of four in-depth stories based on the insights provided by key regulatory experts on China at the AAPS and ISPE annual meetings this fall....
December 15, 2011 | Posted in The News in Depth | Read More »

ICH Q11 Nears Final Approval After Comments Prompt Changes in Step 2 Draft

The final version of ICH’s drug substance development and manufacturing guideline Q11 is nearing Step 4 clearance by the regulatory agencies in the three ICH regions following some significant changes the Expert Working Group (EWG) has made to the Step 2 draft based on the comments received....
December 12, 2011 | Posted in API, CMC Review Policy, ICH Q11, International, International Harmonization, Post-approval Changes, Region/International, Specific Product Type, The News in Depth | Read More »

Quality Culture Indicators Explored by UK Veteran Inspector Thrussell at ICH Q10 Conference

Key indicators of a healthy quality culture include a company’s understanding of ● the price of noncomformance ● the difference between change control and change management ● and the value of openness with regulators, UK Medicines and Health products Regulatory Agency (MHRA) Expert GMP Inspector Ian Thrussell stressed at a quality systems/ICH Q10 conference in Arlington, Virginia in early October....
December 8, 2011 | Posted in Authorities, Europe, GMP Policy, International, Region/International, The News in Depth | Read More »

Ben Venue Plant Shutdown Leads to Critical Drug Shortages

Two drugs contract-manufactured by Ben Venue are now in short supply after the firm voluntarily shut down its Bedford, Ohio plant in November to investigate quality and manufacturing issues highlighted in recent FDA and EMA inspections. Doxil – marketed by New Brunswick, New Jersey-based Johnson & Johnson and used to treat ovarian cancer, multiple myeloma and [...]
December 7, 2011 | Posted in GMP Deviations/Warning Letters, GMP Enforcement Activity, Injectable, News Brief, Region/International, Specific Product Type, US/Canada | Read More »
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